Factors Affecting Medication Adherence to Topical Acne Medications: a Single-center, Prospective Study Evaluating the Adherence and Patient Satisfaction to Single and Multiple Topical Acne Medications

Acne is a chronic condition that typically requires the use of multiple medications.1 Medication adherence is especially challenging for patients with chronic diseases and often decreases over time, especially for those using topical medications.1 Nonadherence can result in multiple negative effects including treatment failure, increased healthcare costs, and decreased quality of life. Primary nonadherence refers to problems acquiring and starting treatment. Challenges to this form of nonadherence include a lack of knowledge, misunderstanding of usage, poor communication with provider, increased cost, and fear of side effects.2 Secondary nonadherence refers to when the patient does not use the medication as prescribed. Hurdles to secondary nonadherence include delayed results, increased complexity of treatment plan, adverse effects, busy lifestyle, and inconvenience.2

Start Date01 Jul 2024

Sponsor / Collaborator

Wake Forest School of Medicine

[+1]

CTRI/2024/02/062423 / Not yet recruitingNot Applicable

Efficacy and Safety of Topical Adapalene(0.1%W/W) & CLINDAMYCIN(1%W/W) versus Topical Adapalene(0.1%W/W) & Benzoyl peroxide(2.5%W/W) in Inflammatory Acne Vulgaris: A Comparative study

Start Date16 Feb 2024

Sponsor / Collaborator-

NCT06141330 / Not yet recruitingNot ApplicableIIT

Vitamin D Supplementation in Combination With Azithromycin and Topical Retinoid for Acne: A Randomized Controlled Trial

The goal of this clinical trial is to compare in acne vulgaris patients. The main question it aims to answer is:
• To assess the therapeutic benefit of vitamin D supplement in acne vulgaris treatment, following a 2-month treatment regimen that includes vitamin D supplementation compared to conventional (systemic azithromycin and topical retinoid) treatment alone.
Participants will receive vitamin D supplements in addition to capsule Azithromycin and topical retinoid.
Researchers will compare groups to determine efficacy of Vitamin D supplements in the treatment of Acne vulgaris.

Start Date01 Dec 2023

Sponsor / Collaborator-

100 Clinical Results associated with Adapalene

100 Translational Medicine associated with Adapalene

100 Patents (Medical) associated with Adapalene

565

Literatures (Medical) associated with Adapalene

01 Feb 2024·Computational biology and chemistry

Targeting AR-positive breast cancer cells via drug repurposing approach

Article

Author: Sen, Plaboni ; Dutta, Parijat ; Kandasamy, Thirukumaran ; Ghosh, Siddhartha Sankar

Androgen Receptor (AR) is overexpressed in almost all the molecular subtypes of breast cancer. Besides aiding the tumorigenic environment of cancer by abnormal cell proliferation, AR also takes part in promoting cancer signaling pathways, thereby promoting aggressiveness. In this study, AR was selected as the target protein in breast cancer cells. Following this, a library of 1293 FDA-approved drugs was screened via molecular docking, MD simulation, and MMPBSA binding energy. Amongst the library of compounds, Adapalene exhibited the least binding energy of (-10.2 kCal/mol) in comparison to that of the chosen reference compound, Nilutamide (-8.6 kCal/mol). Furthermore, the in vitro efficacy of Adapalene was also determined in two different breast cancer cell lines such as MCF7 (AR-positive/ER-positive) and MDA-MB-231 (AR negative/TNBC). Initially, the cell viability assay (MTT) was performed, which endowed us with a lesser IC₅₀ value of Adapalene in comparison to Nilutamide in both cell lines. The IC₅₀ of Adapalene was found to be 12 μM and 39.4 μM in MCF7 and MDA-MB-231 cells, respectively. Furthermore, Adapalene also induced cellular ROS and apoptosis by 3.5-fold and 26.58% in MCF7 cells. However, the overall effect of Adapalene was significantly lower in the case of MDA-MB-231 cell lines, which could be attributed to its inherent nature of the absence of hormone receptors. Conclusively, Adapalene possesses greater therapeutic efficacy in comparison to the control drug, thereby hinting towards the potential use of Adapalene in the treatment of AR-positive breast cancer.

01 May 2024·Journal of cosmetic dermatology

Efficacy of ceramides and niacinamide‐containing moisturizer versus hydrophilic cream in combination with topical anti‐acne treatment in mild to moderate acne vulgaris: A split face, double‐blinded, randomized controlled trial

Article

Author: Tempark, Therdpong ; Shem, Andrew ; Lueangarun, Suparuj

Abstract:

Introduction:

Topical therapy is the mainstay treatment of acne, and topical retinoids such as tretinoin, tazarotene, and adapalene are recommended as the first‐line therapy for mild to moderate acne. However, the cutaneous irritations may occur, and the dermocosmetics are recommended to prevent side effects of anti‐acne drugs and adhere to treatment. Thus, this study aims to compare the efficacy and tolerability of ceramides and niacinamide‐containing moisturizer (CCM) versus hydrophilic cream in combination with topical anti‐acne treatment in mild to moderate acne vulgaris.

Methods:

This was an 8‐week, randomized, double‐blinded, split face study in 40 patients assigned for topical anti‐acne medications (5% benzoyl peroxide and 0.1% adapalene gel), then randomly applied CCM or hydrophilic cream. All patients were followed at week 0, 2, 4, and 8 for acne improvement, adverse reactions, biometric, and biophysical evaluation.

Results:

CCM could significantly improve the non‐inflammatory, inflammatory, and total acne lesions compared with hydrophilic cream after week 8 of treatment. Interestingly, there was an improvement of global worst score, hemoglobin index, melanin index, TEWL, skin hydration, sebum production, and skin surface pH, with no statistically significant differences between the two treatments. No serious side effects from clinical application of CCM and hydrophilic cream in mild to moderate acne vulgaris patients.

Conclusion:

Ceramide and niacinamide‐containing moisturizer in combination with anti‐acne medication can significantly improve acne lesions and decrease cutaneous irritations toward a satisfactory treatment outcome of mild to moderate acne vulgaris.

01 Feb 2024·Journal of drugs in dermatology : JDD

Benefit of Topical Combination Therapy for Acne: Analyzing Effect Size Using Number Needed to Treat

Article

Author: Callender, Valerie D ; Han, George ; Bhatia, Neal ; Feldman, Steven R ; Tyring, Stephen K ; Gold, Linda Stein ; Kircik, Leon H ; Zeichner, Joshua A

BACKGROUND:

Topical acne trials often are confounded by high vehicle response rates and differing outcome measures, making it difficult to compare treatments. Number needed to treat (NNT) can be a simple, clinically meaningful way to indirectly compare treatment options without head-to-head data. NNT is the number of patients who need to be treated with an intervention to observe one additional patient successfully achieving a desired outcome versus vehicle/placebo. While treatment attributes such as adverse events may not be captured, lower NNT is a good indicator of a more effective treatment.

METHODS:

Following a search of combination topical treatments for acne vulgaris, all treatments that reported pivotal trial efficacy data consistent with the 2018 FDA definition of success were included in NNT analyses. Results: Of 13 treatments, 7 reported 12-week treatment success rates in 11 phase 3 trials, with similar baseline demographics/disease severity. Treatment success ranged from 26.8% with tretinoin 0.1%/benzoyl peroxide (BPO) 3% cream to 50% with triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel. NNTs for the triple-combination gel were 4 and 5 (from 2 pivotal trials). Adapalene 0.3%/BPO 2.5% gel had an NNT of 5. Tretinoin/BPO had the largest range between trials, with NNTs of 4 and 9. The other 4 treatments had NNTs ranging from 6 to 8.

CONCLUSION:

A comparison of combination topical acne treatment trial data, using the same treatment outcome and similar patient populations, resulted in triple-combination clindamycin phosphate/adapalene/BPO gel and adapalene/BPO gel having the most favorable NNTs.J Drugs Dermatol. 2024;23(2):42-49. doi:10.36849/JDD.7927.

News (Medical) associated with Adapalene

31 Jan 2024

·www.prnewswire.com

AMERICAN ACADEMY OF DERMATOLOGY ISSUES UPDATED GUIDELINES FOR THE MANAGEMENT OF ACNE

Both newly approved and well-established treatments recommended ROSEMONT, Ill., Jan. 31, 2024 /PRNewswire/ -- Acne is the most common skin condition in the United States, affecting nearly 50 million Americans each year, with symptoms usually beginning in puberty. Acne affects 85% of adolescents and can also often begin or continue in adulthood, especially in women. To help ensure that people with acne get the best possible treatment, the American Academy of Dermatology (AAD) has published updated guidelines of care for the management of acne in adults, adolescents, and children over the age of 9 in the Journal of the American Academy of Dermatology. Continue Reading "These guidelines provide important updates to the 2016 AAD acne guidelines, including discussion of new topical medications, which are directly applied to the skin, and systemic treatments, which are taken by mouth," said board-certified dermatologist John S. Barbieri, MD, MBA, FAAD, co-chair of the AAD's Acne Guideline Workgroup. "This update provides evidence-based recommendations for dermatologists and other clinicians caring for patients with acne." Acne affects 85% of adolescents and can also often begin or continue in adulthood, especially in women. Post this Updates to the management of acne vulgaris provides 18 evidence-based recommendations for topical, systemic, and physical treatment methods, including newly approved therapeutic options, and 5 good practice statements. Strong recommendations were made for the use of the following: Topical benzoyl peroxide to reduce the amount of acne-causing bacteria on the skin. Topical retinoids (e.g. adapalene, tretinoin, tazarotene, trifarotene) to help unclog pores and reduce inflammation. Oral antibiotics, such as oral doxycycline, and topical antibiotics to reduce the amount of acne-causing bacteria on the skin and lessen inflammation. Combinations of topical benzoyl peroxide, retinoids, or the above antibiotics. Employing best practices in guideline development, the multidisciplinary workgroup also issued 5 good practice statements. When managing acne with topical medications, the guidelines recommend combining multiple different treatment types, as this can lead to better results. The guidelines recommend limiting use of oral antibiotics when possible to reduce the development of antibiotic resistance and other antibiotic-associated complications. It is recommended that topical and oral antibiotics are used simultaneously with benzoyl peroxide to prevent the development of antibiotic resistance. For patients with larger acne bumps, the guidelines recommend injectable corticosteroids as a potential option for more rapid relief of inflammation and pain. For patients with severe acne or for patients who have failed standard treatment with oral or topical therapy, the guidelines recommend isotretinoin. Additionally, the guidelines provide conditional recommendations. Conditional recommendations apply to most patients, but the most appropriate action may differ depending on individual patient factors. Topical clascoterone, which addresses hormonal causes of acne. Topical salicylic acid to unclog pores and exfoliate the skin. Topical azelaic acid to unclog pores, kill bacteria, and fade dark spots that may continue when an acne spot clears. Oral minocycline or sarecycline to reduce the amount of acne-causing bacteria on the skin and lessen inflammation. Hormonal therapies such as combined oral contraceptives or spironolactone to address hormonal causes of acne. Available evidence was insufficient to develop recommendations for procedures such as chemical peels, laser and light-based devices, microneedling, as well as for dietary changes, or alternative therapies such as vitamins or plant-based products. Additionally, a conditional recommendation against adding broadband light, intense pulsed light, to adapalene 0.3% gel. "Board-certified dermatologists are on the forefront of new and exciting advances in the treatment of acne," said Dr. Barbieri. "We are able to offer our patients with acne more options than ever before as we work to address their concerns and determine the most effective treatment plan possible. Just as important, dermatologists must have access to all available therapeutic options." Since there are a variety of treatment options for acne and treatment plans are not one-size-fits-all, it is important to partner with a board-certified dermatologist to decide which options work best for you. To find a board-certified dermatologist in your area, visit aad.org/findaderm. More Information Acne resource center Acne treatment AAD B-Roll Library About the AAD Headquartered in Rosemont, Ill., the American Academy of Dermatology, founded in 1938, is the largest, most influential and most representative of all dermatologic associations. With a membership of more than 20,800 physicians worldwide, the AAD is committed to advancing the diagnosis and medical, surgical, and cosmetic treatment of the skin, hair, and nails; advocating high standards in clinical practice, education and research in dermatology; and supporting and enhancing patient care because skin, hair, and nail conditions can have a serious impact on your health and well-being. For more information, contact the AAD at (888) 462-DERM (3376) or aad.org. Follow @AADskin on Facebook, TikTok, Pinterest and YouTube and @AADskin1 on Instagram. SOURCE American Academy of Dermatology

30 Jan 2024

·www.biospace.com

CABTREO(TM) (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel for the Treatment of Acne Vulgaris Now Available in the U.S.

LAVAL, QC / ACCESSWIRE / January 30, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its dermatology business, Ortho Dermatologics, today announced the U.S. launch of CABTREO™ (clindamycin, adapalene, benzoyl peroxide) Topical Gel, 1.2%/0.15%/3.1% indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. "With today's launch of CABTREO, millions of Americans who suffer from acne each year have access to a new once-daily triple-combination topical acne treatment," Thomas J. Appio, Chief Executive Officer, said. "In many instances, acne treatment requires using multiple products and dosing regimens, which can pose a number of challenges for patients. CABTREO has the potential to simplify dosing with a once daily topical acne treatment regimen." CABTREO Topical Gel is the first and only U.S. Food and Drug Administration-approved fixed-dose, once-daily triple-combination topical treatment for acne and offers three mechanisms of action, combining an antibiotic, retinoid and antibacterial, to provide a proven, safe and effective treatment. The FDA approved CABTREO Topical Gel on Oct. 20, 2023, based on data from two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies that demonstrated CABTREO Topical Gel resulted in statistically significant reductions in both inflammatory and non-inflammatory lesions compared to vehicle. At week 12, 50.0% of participants achieved treatment success with CABTREO versus 22.6% with vehicle gel (P<0.001). CABTREO resulted in >70% reductions in inflammatory and noninflammatory lesions at week 12 (77.9%% and 73.0%, respectively), which were significantly greater than vehicle (57.9% and 48.2%; P<0.001, both). The most common adverse reactions (occurring in >1% of the CABTREO group and greater than the vehicle group) were application site reactions, pain, erythema, dryness, irritation, exfoliation, and dermatitis. About Acne Vulgaris Acne is the most common skin problem in the United States, which occurs when hair follicles become obstructed with sebum and skin cells, resulting in the formation of whiteheads, blackheads, or pimples on the face, forehead, chest, upper back and shoulders.1,2 Up to 50 million Americans have acne.2 Depending on its severity, acne can cause emotional distress and scar the skin.2 What is CABTREO? CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1% is a prescription medicine used on the skin only (topical use) to treat acne vulgaris in adults and children 12 years of age and older. Do not use CABTREO in your mouth, eyes, or vagina. IMPORTANT SAFETY INFORMATION Do not use CABTREO if you have had an allergic reaction to clindamycin, adapalene, benzoyl peroxide, lincomycin, or any of the ingredients in CABTREO or have Crohn's disease, ulcerative colitis, inflammation of the colon (colitis), or severe diarrhea with antibiotic use. Before using CABTREO, tell your healthcare provider about all your medical conditions, including if you: plan to have surgery, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed, have other skin problems, including cuts, abrasions, sunburn, or eczema; or use other skin and topical acne products that may increase the irritation of your skin when used with CABTREO. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and if you take or use a medicine that contains erythromycin. CABTREO should not be used with products that contain erythromycin. What should I avoid while using CABTREO? Avoid or limit your time in sunlight, including use of sunlamps or tanning beds during treatment with CABTREO as it can make you more sensitive, and you could get severe sunburn. Use sunscreen and wear clothes including a hat that covers the treated areas of your skin if you have to be in sunlight. Cold weather and wind may irritate skin treated with CABTREO. Avoid applying CABTREO to areas with skin problems including, cuts, abrasions, sunburned skin, or eczema. Avoid skin products that may dry or irritate your skin. Avoid the use of "waxing" as a hair removal method on skin treated with CABTREO. What are the possible serious and most common side effects of CABTREO? Tell your doctor right away if you experience side effects, including: Allergic reactions: Stop using CABTREO if you have hives, rash, severe itching, swelling of your face, eyes, lips, tongue or throat, trouble breathing, throat tightness, feeling faint, dizzy, or lightheaded. Inflammation of the colon (colitis): Stop using CABTREO if you have severe stomach (abdominal) cramps, watery diarrhea, or bloody diarrhea during treatment, and within several weeks after treatment with CABTREO. Sensitivity to sunlight. See "What should I avoid while using CABTREO". Skin irritation at the application site is common with CABTREO and may include redness, scaling, dryness, stinging, burning, itching, and swelling. These are not all the possible side effects of CABTREO. Call your doctor for medical advice about side effects. You may report side effects to Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA- 1088 or Please click here for full Prescribing Information, Patient Information and Instructions for Use. About Ortho Dermatologics Ortho Dermatologics is one of the largest prescription and aesthetic dermatology businesses dedicated to helping patients in the treatment of a range of conditions, including psoriasis, onychomycosis, actinic keratosis, acne, atopic dermatitis and other dermatoses. More information can be found at . About Bausch Health Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch +Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit and connect with us on Twitter and LinkedIn. Forward-Looking Statements This news release may contain forward-looking statements about the future performance of Bausch Health which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. References 1. American Academy of Dermatology. (2020). Skin conditions by the numbers. Retrieved from . Accessed March13, 2023. 2. Mayo Clinic. (2020). Acne. Retrieved from . Accessed March 13, 2023. Investor Contact: ir@bauschhealth.com (877) 281-6642 (toll free) Media Contact: Kevin Wiggins corporate.communications@bauschhealth.com (848) 541-3785 ### CABTREO™ is a trademark of Ortho Dermatologics' affiliated entities. Ortho Dermatologics is a trademark of Ortho Dermatologics' affiliated entities. © 2024 Ortho Dermatologics' affiliated entities. CAB.0025.USA.24 SOURCE: Bausch Health Companies Inc. View the original press release on accesswire.com

Phase 3Clinical ResultDrug Approval

20 Oct 2023

·www.biospace.com

FDA Approves Cabtreo(TM) (Clindamycin Phosphate, Adapalene and Benzoyl Peroxide) Topical Gel for the Treatment of Acne Vulgaris in Patients Twelve Years of Age and Older

First and only FDA-approved fixed-dose, triple-combination topical treatment LAVAL, QC / ACCESSWIRE / October 20, 2023 / Bausch Health Companies Inc. (NYSE:BHC) (TSX:BHC) ("Bausch Health") and its dermatology business, Ortho Dermatologics, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for CABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, indicated for the topical treatment of acne vulgaris in patients twelve years of age and older. CABTREO is the first and only FDA-approved fixed-dose, triple-combination topical treatment for acne. CABTREO is expected to be available to patients in Q1 2024. "With today's approval of CABTREO, millions of Americans who suffer from acne each year have a new triple-combination topical acne treatment," said Thomas J. Appio, Chief Executive Officer, Bausch Health. "Acne treatment often requires using multiple products and dosing regimens, which can pose a number of challenges for patients. CABTREO has the potential to simplify dosing with a once daily topical acne treatment regimen." CABTREO offers three mechanisms of action, combining an antibiotic, retinoid and antibacterial, to provide a proven, safe and effective treatment. "While most acne treatments currently available utilize multiple therapies and regimens, we are excited to see that the triple combination in CABTREO has resulted in significant treatment success and reduction in both the inflammatory and noninflammatory lesions typically associated with acne," said Julie C. Harper, MD., Dermatology & Skin Care Center of Birmingham, Birmingham, AL. "With the approval of CABTREO, physicians can now offer patients an acne treatment that has the potential to be a simple, once daily dosing option." CABTREO Comprehensive Clinical Data CABTREO was studied in two Phase 3 multicenter, randomized, placebo controlled clinical trials in 363 patients with acne vulgaris. Both studies met all co-primary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count, and percentage of patients achieving treatment success (2 grade reduction of the EGSS (evaluators global severity score) from baseline with an EGSS score of clear (0) or almost clear (1)). Combined efficacy results for both trials for CABTREO achieved approximately 50% treatment success and approximately 75% reduction in both inflammatory and noninflammatory lesions at Week 12. In Study 1, 49.6% of participants achieved treatment success with CABTREO compared to 24.9% with vehicle. Mean percent reduction for inflammatory lesions was 75.7% (27.7 mean absolute reduction) vs. 59.6% (21.7 mean absolute reduction) with vehicle. Mean percent reduction for non-inflammatory lesions was 72.7% (35.4 mean absolute reduction) vs. 47.6% (23.5 mean absolute reduction) with vehicle. In Study 2, 50.5% of participants achieved treatment success with CABTREO compared to 20.5% with vehicle. Mean percent reduction for inflammatory lesions was 80.1% (30.1 mean absolute reduction) vs. 56.2% (20.8 mean absolute reduction) with vehicle. Mean percent reduction for non-inflammatory lesions was 73.3% (35.2 mean absolute reduction) vs. 49.0% (22.0 mean absolute reduction) with vehicle. The most common adverse reactions (occurring in >1% of the CABTREO group and greater than the vehicle group) were application site reactions, pain, erythema, dryness, irritation, exfoliation, and dermatitis. About Acne Vulgaris Acne is the most common skin problem in the United States, which occurs when hair follicles become obstructed with sebum and skin cells, resulting in the formation of whiteheads, blackheads, or pimples on the face, forehead, chest, upper back and shoulders.1,2 Up to 50 million Americans have acne.2 Depending on its severity, acne can cause emotional distress and scar the skin.2 What is CABTREO? CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1% is a prescription medicine used on the skin only (topical use) to treat acne vulgaris in adults and children 12 years of age and older. Do not use CABTREO in your mouth, eyes, or vagina. IMPORTANT SAFETY INFORMATION Before using CABTREO, tell your healthcare provider about all your medical conditions, including if you: plan to have surgery, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed, have other skin problems, including cuts, abrasions, sunburn, or eczema; or use other skin and topical acne products that may increase the irritation of your skin when used with CABTREO. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and if you take or use a medicine that contains erythromycin. CABTREO should not be used with products that contain erythromycin. Do not use CABTREO if you have had an allergic reaction to clindamycin, adapalene, benzoyl peroxide, lincomycin, or any of the ingredients in CABTREO or have Crohn's disease, ulcerative colitis, inflammation of the colon (colitis), or severe diarrhea with antibiotic use. What should I avoid while using CABTREO? Avoid or limit your time in sunlight, including use of sunlamps or tanning beds during treatment with CABTREO as it can make you more sensitive, and you could get severe sunburn. Use sunscreen and wear clothes including a hat that covers the treated areas of your skin if you have to be in sunlight. Cold weather and wind may irritate skin treated with CABTREO. Avoid applying CABTREO to areas with skin problems including, cuts, abrasions, sunburned skin, or eczema. Avoid skin products that may dry or irritate your skin. Avoid the use of "waxing" as a hair removal method on skin treated with CABTREO. What are the possible serious and most common side effects of CABTREO? Tell your doctor right away if you experience side effects, including: Allergic reactions: Stop using CABTREO if you have hives, rash, severe itching, swelling of your face, eyes, lips, tongue or throat, trouble breathing, throat tightness, feeling faint, dizzy, or lightheaded. Inflammation of the colon (colitis): Stop using CABTREO if you have severe stomach (abdominal) cramps, watery diarrhea, or bloody diarrhea during treatment, and within several weeks after treatment with CABTREO. Sensitivity to sunlight. See "What should I avoid while using CABTREO". Skin irritation at the application site is common with CABTREO and may include redness, scaling, dryness, stinging, burning, itching, and swelling. These are not all the possible side effects of CABTREO. Call your doctor for medical advice about side effects. You may report side effects to Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or . Please click here for full Prescribing Information, Patient Information and Instructions for Use. About Ortho Dermatologics Ortho Dermatologics is one of the largest prescription and aesthetic dermatology businesses dedicated to helping patients in the treatment of a range of conditions, including psoriasis, onychomycosis, actinic keratosis, acne, atopic dermatitis and other dermatoses. More information can be found at . About Bausch Health Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit and connect with us on Twitter and LinkedIn. References American Academy of Dermatology. (2020). Skin conditions by the numbers. Retrieved from . Accessed March 13, 2023. Mayo Clinic. (2020). Acne. Retrieved from . Accessed March 13, 2023. ### CABTREOTM is a trademark of Ortho Dermatologics' affiliated entities. Ortho Dermatologics is a trademark of Ortho Dermatologics' affiliated entities. © 2023 Ortho Dermatologics' affiliated entities. CAB.0055.USA.23 Bausch Health Investor Contact: ir@bauschhealth.com Bausch Health Media Contact: Kevin Wiggins corporate.communications@bauschhealth.com SOURCE: Bausch Health Companies Inc. View source version on accesswire.com:

Clinical ResultPhase 3Drug Approval

100 Deals associated with Adapalene

External Link

KEGG	Wiki	ATC	Drug Bank
D01112	Adapalene	D10AD03	DB00210

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Acne Vulgaris	US	Galderma Laboratories LP	31 May 1996

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Photodamaged skin	Phase 3	BR	Galderma Brasil Ltda.	01 Jan 2013
Skin aging	Phase 3	BR	Galderma Brasil Ltda.	01 Jan 2013
Atrophic acne scar	Phase 2	US	Galderma Holding SA	01 Mar 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed	Phase 3	Acne Vulgaris	-	Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% gel (CAB)	tigqfctoxv(nxbnhvtttr) = Most TEAEs were of mild-moderate severity, and < 3% of CAB-treated participants discontinued study/treatment because of AEs fqfdulrkak (wisezgoxrb ) View more	Positive	09 May 2024
				Vehicle gel
NCT00422240 (CTgov)	Phase 3	Acne Vulgaris	1,668	Adapalene/Benzoyl Peroxide (Adapalene/Benzoyl Peroxide Gel)	gbxctprkut(wjdxoknjup) = xcmfuljtlr lwgilivldc (aandwxpbhm, jnqfkfnmmp - atabikocut) View more	-	15 Apr 2024
				Adapalene Gel, 0.1% (Adapalene Gel, 0.1%)	gbxctprkut(wjdxoknjup) = schoxdvxmd lwgilivldc (aandwxpbhm, mbiruwgign - qrazifqwmp) View more
AAD2023	Not Applicable	-	-	Adapalene 0.1% gel	ovowulgfrn(lhpcihktpa) = bmivulovif aptelmeukb (xryvuynusz ) View more	-	17 Mar 2023
				Tretinoin	ovowulgfrn(lhpcihktpa) = tcdcemvxmq aptelmeukb (xryvuynusz ) View more
EADV2022	Not Applicable	Moderate to severe acne	47	Dapsone 7.5% gel	yaieyngmca(zhamtgbxug) = uumcwmtsth hjuyrebddz (numozobsow ) View more	Positive	12 May 2022
				Adapalene 0.1% gel	yaieyngmca(zhamtgbxug) = cnueqeilto hjuyrebddz (numozobsow ) View more
NCT02525549 (CTgov)	Phase 3	Acne Vulgaris	903	Adapalene+Benzoyl Peroxide Gel (Test Product)	lgcjbggcbe(wbfcehuunw) = ehoxsbhimr tqhvlwnucf (vjkdburzzi, ppbxunjgtj - xlgstyywxj) View more	-	20 Jan 2021
				Adapalene (Reference Product)	lgcjbggcbe(wbfcehuunw) = xkzjmfvboa tqhvlwnucf (vjkdburzzi, wogcifrtzl - bmdvflynhb) View more
NCT03393494 (CTgov)	Phase 3	Acne Vulgaris	825	Adapalene+Benzoyl Peroxide Topical Gel (Perrigo Active)	qnpaeozbuj(gxcbappgsv) = zoczorpyog ttjjuajjso (dmjcctqidk, wcacvtwkzf - mhaztbpmdt) View more	-	05 Jan 2021
				Epiduo Topical Product (Reference Active)	qnpaeozbuj(gxcbappgsv) = atujdwwpdm ttjjuajjso (dmjcctqidk, hcktzmbyrc - kccawqagqp) View more
NCT02651220 (CTgov)	Phase 3	Acne Vulgaris	1,001	Adapalene+Benzoyl Peroxide Gel (Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w)	odnvjchknz(kkdufmmiin) = toaaaqfufa zruqniioex (pyidfmriym, yvjbxkxspc - nggrdfcyko) View more	-	23 Jun 2020
				Epiduo® Forte Gel (Epiduo® Forte Gel 0.3%/2.5% w/w)	odnvjchknz(kkdufmmiin) = ooxzgsdhvf zruqniioex (pyidfmriym, quhmiamtrx - tzsttdobsm) View more
ERS2018	Not Applicable	Skin Diseases First line EGFR-activating mutations	-	Adapalene	gztuwjeipm(ghmnwcdslm) = sgfdqxakhm mlhniwzzwm (bvucyuamfd )	Positive	15 Sep 2018
				Erlotinib+TNF-a+IL-1b	gztuwjeipm(ghmnwcdslm) = tsxpxceurf mlhniwzzwm (bvucyuamfd )
NCT00671749 (CTgov)	Phase 4	Acne Vulgaris	100	Differin+Duac	hxpgzteolu(aswumwulyd) = rdwqxonkbu zjxsjfxkxg (fhaxprhbky, upkezocqdq - bgizsxhdyy) View more	-	16 Mar 2016
NCT01231334 (CTgov)	Phase 4	Acne Vulgaris	286	adapalene+Dapsone (Aczone® Gel 5% Plus Differin® 0.3% Gel)	jukgkrsoxf(awjmhkaqnl) = hacztbvxsg dwgphvbyzy (bldgrrvftn, rudozaurxp - wgxlwoxlht) View more	-	27 Jul 2012
				Adapalene+Dapsone (Duac® Topical Gel Plus Differin® 0.3% Gel)	jukgkrsoxf(awjmhkaqnl) = objyztjmdt dwgphvbyzy (bldgrrvftn, ehbwjsboug - sqfbiwviys) View more

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