[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-cycle, two-sequence, double-crossover fasting bioequivalence study of crisaborole ointment in healthy subjects

主要目的：以药代动力学参数作为主要终点评价指标，比较在空腹状态下外用受试制剂克立硼罗软膏（持证商：河北合渡药业有限公司）与参比制剂克立硼罗软膏（持证商：Anacor Pharmaceuticals, LLC.，商品名：舒坦明®）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：（1）观察受试制剂克立硼罗软膏和参比制剂克立硼罗软膏在健康受试者中的安全性；（2）评价受试制剂克立硼罗软膏和参比制剂克立硼罗软膏对健康受试者的皮肤反应性。

[Translation]

Primary objective: To compare the pharmacokinetic behavior of the test preparation crisaborole ointment (licensed by: Hebei Hedu Pharmaceutical Co., Ltd.) and the reference preparation crisaborole ointment (licensed by: Anacor Pharmaceuticals, LLC., trade name: Sutanming®) in healthy subjects after external application in the fasting state, using pharmacokinetic parameters as the primary endpoint evaluation indicators, and to evaluate the bioequivalence of the two preparations. Secondary objectives: (1) To observe the safety of the test preparation crisaborole ointment and the reference preparation crisaborole ointment in healthy subjects; (2) To evaluate the skin reactivity of the test preparation crisaborole ointment and the reference preparation crisaborole ointment in healthy subjects.

Start Date22 Oct 2024

Sponsor / Collaborator

Hebei Hedu Pharmaceutical Co., Ltd.

CTR20242835 / CompletedNot Applicable

克立硼罗软膏人体生物等效性试验

[Translation] Bioequivalence study of crisaborole ointment in human body

采用单中心、随机、开放、双周期交叉、两制剂、两序列、单次给药设计，比较空腹给药条件下，健民药业集团股份有限公司提供的克立硼罗软膏（规格：2%）与Anacor Pharmaceuticals, Inc.持证的克立硼罗软膏（商品名：舒坦明®/Staquis®，规格：2%）在中国健康人群中吸收程度和吸收速度的差异，并评价健民药业集团股份有限公司提供的克立硼罗软膏（规格：2%）的安全性。

[Translation]

A single-center, randomized, open, two-period crossover, two-drug, two-sequence, single-dose design was used to compare the differences in absorption extent and rate between crisaborole ointment (specification: 2%) provided by Jianmin Pharmaceutical Group Co., Ltd. and crisaborole ointment (trade name: Staquis®/Staquis®, specification: 2%) licensed by Anacor Pharmaceuticals, Inc. in healthy Chinese people under fasting conditions, and to evaluate the safety of crisaborole ointment (specification: 2%) provided by Jianmin Pharmaceutical Group Co., Ltd.

Start Date05 Sep 2024

Sponsor / Collaborator

Jianmin Pharmaceutical Group Co., Ltd.

CTR20243068 / CompletedNot Applicable

健康受试者在空腹状态下单次外用克立硼罗软膏的人体生物等效性试验

[Translation] A human bioequivalence study of a single topical application of crisaborole ointment in healthy subjects in the fasting state

主要目的：以山东百诺医药股份有限公司提供，药源生物科技（启东）有限公司生产的克立硼罗软膏为受试制剂，以Anacor Pharmaceuticals, Inc.持证的克立硼罗软膏（商品名：舒坦明®/Staquis®）为参比制剂，评估健康受试者在空腹状态下单次局部外用受试制剂和参比制剂的药代动力学特征，评价两种制剂的人体生物等效性。次要目的：考察健康受试者使用受试制剂和参比制剂后的安全性。

[Translation]

Main purpose: Using the crisaborole ointment provided by Shandong Bainuo Pharmaceutical Co., Ltd. and produced by Yaoyuan Biotechnology (Qidong) Co., Ltd. as the test preparation, and the crisaborole ointment (trade name: Staquis®/Staquis®) certified by Anacor Pharmaceuticals, Inc. as the reference preparation, the pharmacokinetic characteristics of the test preparation and the reference preparation after single topical application in healthy subjects under fasting state were evaluated, and the human bioequivalence of the two preparations was evaluated. Secondary purpose: To investigate the safety of healthy subjects after using the test preparation and the reference preparation.

Start Date26 Aug 2024

Sponsor / Collaborator

Shandong Bestcomm Pharmaceutical Co., Ltd.

100 Clinical Results associated with Crisaborole

100 Translational Medicine associated with Crisaborole

100 Patents (Medical) associated with Crisaborole

193

Literatures (Medical) associated with Crisaborole

01 Nov 2024·Journal of Cosmetic Dermatology

Utility of prostaglandin analogues and phosphodiesterase inhibitors as promising last resorts for the treatment of vitiligo: A systematic review, from mechanisms of action to mono‐, combination and comparative therapies

Review

Author: Abtahi‐Naeini, Bahareh ; Pourriyahi, Homa ; Nooshabadi, Mohammadreza Padooiy ; Baradaran, Hamid Reza ; Goodarzi, Azadeh ; Pourriahi, Homayoun ; Hosseini, Nastaran‐Sadat

AbstractBackgroundThe treatment of vitiligo is a persistent challenge in dermatology. New treatments are being offered and studied in this field for those resistant to or intolerant of classical therapies.AimsIn this systematic review, we study the use of prostaglandin analogues (PGAs) and phosphodiesterase inhibitors (PDEIs) in the treatment of vitiligo, as they are known for their pigmentation inducing effects through activating melanocytes.MethodsWe searched four main online databases with the keywords “Vitiligo”, “Prostaglandin analogue” and “Phosphodiesterase inhibitor”.ResultsA total of 42 articles were included, with 1027 cases, studying drugs like bimatoprost, latanoprost, travoprost, dinoprostone, apremilast, crisaborole, etc. Among the included studies, the treatment regimens are commonly once or twice daily for 12–48 weeks, with a mean of 20.61 weeks, and the routes of administration are mainly topical gels or ophthalmic solutions and oral tablets. Side effects are mild and tolerable, namely erythema, itching or burning sensations at application site for topicals, or gastrointestinal problems with apremilast. Repigmentation results are significant in both adult and pediatric patients and progressive or stable vitiligo. PGAs and PDEIs outperform many classical therapies, for example, narrowband ultraviolet B phototherapy (NB‐UVB), tacrolimus, mometasone or methylprednisolone mini‐pulse. PGAs or PDEIs are usually used in combination therapies to either cause synergism or increase drug delivery, and almost always enhance repigmentation, for example, with NB‐UVB, fractional CO2 laser, microneedling, and mometasone.ConclusionMonotherapy or add‐on PGAs and PDEIs can be considered effective treatments for vitiligo and promising last resorts for those resistant to other therapies.

01 Oct 2024·International Journal of Dermatology

Real‐world efficacy of 2% crisaborole ointment on chronic hyperplasia lesions in 49 patients with atopic dermatitis

Article

Author: Liu, Zilian ; Ma, Chuan ; Sun, Jiachen ; Zhang, Chunlei

AbstractBackgroundCrisaborole, as a phosphodiesterase 4 (PDE4) inhibitor (PDE4i), effectively inhibits inflammatory pathways, showing promising results in atopic dermatitis (AD), particularly in chronic hyperplasia lesions.ObjectivesBased on real‐world data from China, this study assesses the effectiveness and safety of 2% PDE4i ointment as monotherapy for chronic hyperplastic AD lesions.Materials and methodsA total of 49 AD patients aged 12 and above with chronic hyperplastic lesions and Investigator's Static Global Assessment scores of mild or moderate were enrolled. They received 2% PDE4i ointment twice daily until the lesions completely cleared. The effectiveness endpoints comprised the onset time of pruritus and lesion remission and the time of complete lesion clearance.ResultsPDE4i demonstrated high effectiveness with minimal irritation, notable improvement in hyperpigmentation, and early remission of pruritus and lesions. The response varied across age groups; elderly patients experienced quicker pruritus relief compared to adolescents and adults, while adolescents showed earlier lesion remission by about 3 days. No significant difference was observed across age groups in the time for complete lesion clearance. Additionally, AD duration (less or more than 3 years) did not significantly impact pruritus or lesion remission.ConclusionsPDE4i monotherapy is effective and safe for chronic hyperplasia lesions in AD across all age groups, and its effectiveness appears to be independent of AD duration.

01 Oct 2024·Die Dermatologie

Die Rolle in der Behandlung von Hautkrankheiten

Review

Author: Yazdi, Amir S ; Schmidt, Morna F ; Schmidt, Morna F. ; Yazdi, Amir S. ; Albuscheit, Nicole

BACKGROUNDChronic inflammatory skin diseases are of great social and medical importance and require effective drug therapy. Phosphodiesterase 4 (PDE4) inhibitors represent a possible therapeutic option by regulating inflammatory processes. PDEs cause the release of proinflammatory cytokines by interfering with signaling pathways. The PDE4 inhibitors apremilast (treatment of psoriasis and Behçet's disease), roflumilast (treatment of chronic obstructive pulmonary disease), and crisaborole (treatment of atopic dermatitis) are currently approved in Europe.PSORIASISApremilast is used for second-line treatment of plaque psoriasis and psoriatic arthritis and has a favorable side effect profile. Topical PDE4 inhibitors are currently being researched and have not yet been approved by the European Medicines Agency (EMA).ATOPIC DERMATITISThe topical PDE4 inhibitor crisaborole was approved by the EMA in 2020 as a topical treatment alternative to glucocorticoids and calcineurin inhibitors. Although the substance has shown good tolerability in studies and also alleviates the accompanying itching, it did not find its way onto the German market. BEHçET'S DISEASE: Apremilast is approved for the treatment of Behçet's disease in adults with refractory, severe oral ulcers.OUTLOOKCase studies have also demonstrated the efficacy of systemic PDE4 inhibition in other skin diseases (including blistering autoimmune dermatoses, lichen planus, and acantholytic genodermatoses). The substances are also being researched and used to treat extracutaneous inflammatory diseases.

News (Medical) associated with Crisaborole

29 Aug 2023

·www.fiercepharma.com

Arcutis launches branded Zoryve ad for a 'Cream That Can' as it eyes streaming services for new campaign

Arcutis Biotherapeutics is looking to compete against Amgen's blockbuster rival Otezla. One year after receiving FDA approval, Arcutis Biotherapeutics is launching the first direct-to-consumer ad campaign for its plaque psoriasis therapy Zoryve. The non-steroid drug competes with Amgen's blockbuster Otezla, which generates more than $2 billion annually and has multiple indications. Otezla was the first pill approved for plaque psoriasis. Arcutis aims to distinguish Zoryve from both topical steroids and Otezla by emphasizing its easier method of administration, which can cover all skin areas. This is in contrast to steroidal creams, which may pose safety risks with prolonged use. This focus is evident in its advertisements The commercial features a simple black background with a central focus on people's naked bodies (without showing their faces). A narrator asks, "For plaque psoriasis, why can't there be a steroid-free topical I can use for as long as I need?" Then a new voice comes in, adding: “A cream I can apply, just once a day,” playing on the “Cream That Can” tagline for the campaign. The "Cream That Can" ad will “air across many of the top on-demand video streaming platforms,” the company said in a release, rather than a full focus on TV. Zoryve (roflumilast) works a topical formulation of the PDE4 inhibitor found in AstraZeneca’s chronic obstructive pulmonary disease treatment Daliresp. The psoriasis med crossed the FDA finish line last August, and Arcutis has been ramping up the unbranded awareness campaigns for the dermatology condition before this new DTC. In September 2022, just weeks after the green light for the med, it launched the “Expose Psoriasis” online educational campaign designed to improve the understanding of plaque psoriasis' physical and emotional impact. It also aimed to raise awareness that symptoms may occur anywhere on the body including knees, elbows, torso and sensitive places like the face and genitals. Before that, in April 2022, Arcutis had also released a survey from the Harris Poll that found 75% of people with psoriasis in intertriginous areas, or skin folds, reported a negative impact on their emotional well-being. “The Cream That Can helps make clear skin the hero. No matter where plaque psoriasis may appear on the skin, whether in hard-to-treat areas like knees and elbows, or sensitive areas like the face and skin folds, Zoryve is the cream that can help,” said Ayisha Jeter, interim chief commercial officer at Arcutis, in a press release. Arcutis is hoping to do better than Pfizer’s Eucrisa, which was set to be the next big topical treatment for inflammatory skin diseases, but the ointment never gained traction in psoriasis thanks to side effects and reimbursement hurdles. But Mizuho analysts are bullish on Zoryve's prospects, which works differently to Eucrisa, and believes the Arcutis med can, with other approvals, hit peak annual sales of between $1.8 billion and $3.8 billion in 2030. In the current psoriasis treatment landscape, next-gen biologics such as Novartis’ Cosentyx, Eli Lilly’s Taltz and AbbVie’s Skyrizi have demonstrated remarkable efficacy in psoriasis. But in an interview with Fierce Pharma last year, Arcutis CEO Frank Watanabe said Zoryve isn’t positioned as a competitor to the biologics but rather as being complementary to them.

Drug Approval

12 Jan 2023

·www.prnewswire.com

AMERICAN ACADEMY OF DERMATOLOGY ISSUES UPDATED GUIDELINES FOR THE MANAGEMENT OF ATOPIC DERMATITIS IN ADULTS WITH TOPICAL THERAPIES

Both well-established and newer topical treatments addressed ROSEMONT, Ill., Jan. 12, 2023 /PRNewswire/ -- Often called eczema or atopic eczema, atopic dermatitis is a common skin condition, affecting 1 in 10 Americans1. Although atopic dermatitis occurs most frequently in children, it also affects adults and can have a significant impact on patients' quality of life. To help ensure that adult patients with atopic dermatitis receive the best possible treatment, the American Academy of Dermatology (AAD) has published updated guidelines of care for the management of atopic dermatitis in adults with topical therapies in the Journal of the American Academy of Dermatology. Continue Reading This is the second in a series of updated guidelines the AAD is producing on the condition. The updates, which outline best practices for topical treatment of the disease, were developed by an expert workgroup of 12 physicians, including 11 dermatologists, an allergist/pediatrician and one patient representative. The AAD published updated guidelines of care for the management of atopic dermatitis in adults with topical therapies Tweet this "Atopic dermatitis is the most common type of eczema, and it can interfere with a person's daily life without proper treatment," said board-certified dermatologist Robert Sidbury, MD, MPH, FAAD, co-chair of the AAD's Atopic Dermatitis Guideline Workgroup. "The guidelines provide evidence-based recommendations for dermatologists to use in caring for their adult atopic dermatitis patients with topical treatments, which have come a long way since the guidelines were last revised in 2014. This update reflects the latest advances in topical medications that are now available to help adults with atopic dermatitis." Atopic dermatitis can develop on any area of your skin at any age. Adults who have atopic dermatitis often have red to dark patches and scaly skin. They also can have extremely dry skin, hand eczema, eye problems, and skin that is easily irritated. "While atopic dermatitis cannot be cured, it can be controlled with proper treatment," said Dr. Sidbury. "A plan created by a board-certified dermatologist can help ease symptoms, reduce flare-ups, and prevent it from worsening. Topical treatments remain one of the most popular options due to their effective track record and overall safety." The Atopic Dermatitis Workgroup developed 12 recommendations on how to manage atopic dermatitis in adults with topical therapies. The workgroup provided new recommendations for non-prescription methods as well as prescription treatments. Strong recommendations were made for topical treatments in which the benefits clearly outweigh the risks and burdens to the patient. These recommendations apply to most patients in most circumstances. Strong recommendations were made for the use of the following: Moisturizers help to relieve patients' dry, cracked skin, decrease inflammation, and reduce the severity of and increase the time between flare-ups. Topical calcineurin inhibitors (pimecrolimus 1% cream and tacrolimus 0.03% or 0.1% ointment) reduce patients' inflammation and itching, as well as decrease their flare-ups. Topical corticosteroids are commonly used as the first-line treatment for patients with atopic dermatitis in all skin regions. They help to relieve itching, decrease inflammation, and can decrease infections. Phosphodiesterase-4 inhibitor (crisaborole ointment) can reduce patients' inflammation, help relieve itching, and decrease infections. Janus kinase inhibitor (ruxolitinib cream) can be used short term to ease the inflammation and itching of patients with mild to moderate atopic dermatitis. The guidelines provide conditional recommendations for the use of bathing and wet wrap therapy. Conditional recommendations apply to most patients, but the most appropriate action may differ depending on individual patient factors. Bathing, followed by moisturization , helps patients hydrate the skin. Bleach baths can help patients prevent infection and get rid of bacteria on their skin. Wet wrap therapy utilizes wet bandages to help hydrate and soothe patients' skin. This treatment provides a barrier against scratching, helps to decrease redness and inflammation, and can reduce the bacteria on patients' skin. "These recommendations are based on the latest evidence-based research on the most effective topical treatments for our patients," said Dawn Davis, MD, FAAD, co-chair of the AAD's Atopic Dermatitis Guideline Workgroup. "These recommended treatments can be used individually or in combination with other treatments." The guidelines made conditional recommendations against the use of topical antimicrobials, antiseptics, and antihistamines due to the low certainty of evidence, which means the true effect may be substantially different from the estimated effect. "These guidelines were updated to enable dermatologists to optimize topical treatments to provide adult atopic dermatitis patients with expert care," said board-certified dermatologist Mark D. Kaufmann MD, FAAD, president of the AAD. "Since each patient's atopic dermatitis is unique, board-certified dermatologists can determine the treatments that will work best for them. I'm very grateful to our workgroup for providing these important updates to help patients worldwide." To find a board-certified dermatologist in your area, visit aad.org/findaderm. More information: Eczema Types: Atopic Dermatitis Overview Eczema Types: Atopic Dermatitis Symptoms Guidelines of care for the management of atopic dermatitis in adults with topical therapies About the AAD 1938, is the largest, most influential and most representative of all dermatologic associations. With a membership of more than 20,000 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, Pinterest and YouTube and @AADskin1 on Instagram. About JAAD The Journal of the American Academy of Dermatology is the most widely read dermatology journal in the world, according to Kantar Media. JAAD was the first most-cited dermatology journal in 2021, according to impact factor rankings from Clarivate's Journal Citation Reports (JCR) Web of Science Group. JAAD also has two open-access companion titles: JAAD Case Reports and JAAD International. Follow @JAADJournals on Facebook, Twitter, and Instagram. SOURCE American Academy of Dermatology

12 Jan 2023

·www.biospace.com

American Academy of Dermatology Issues Updated Guidelines for the Management of Atopic Dermatitis in Adults With Topical Therapies

Both well-established and newer topical treatments addressed ROSEMONT, Ill., Jan. 12, 2023 /PRNewswire/ -- Often called eczema or atopic eczema, atopic dermatitis is a common skin condition, affecting 1 in 10 Americans1. Although atopic dermatitis occurs most frequently in children, it also affects adults and can have a significant impact on patients' quality of life. To help ensure that adult patients with atopic dermatitis receive the best possible treatment, the American Academy of Dermatology (AAD) has published updated guidelines of care for the management of atopic dermatitis in adults with topical therapies in the Journal of the American Academy of Dermatology. The AAD published updated guidelines of care for the management of atopic dermatitis in adults with topical therapies This is the second in a series of updated guidelines the AAD is producing on the condition. The updates, which outline best practices for topical treatment of the disease, were developed by an expert workgroup of 12 physicians, including 11 dermatologists, an allergist/pediatrician and one patient representative. "Atopic dermatitis is the most common type of eczema, and it can interfere with a person's daily life without proper treatment," said board-certified dermatologist Robert Sidbury, MD, MPH, FAAD, co-chair of the AAD's Atopic Dermatitis Guideline Workgroup. "The guidelines provide evidence-based recommendations for dermatologists to use in caring for their adult atopic dermatitis patients with topical treatments, which have come a long way since the guidelines were last revised in 2014. This update reflects the latest advances in topical medications that are now available to help adults with atopic dermatitis." Atopic dermatitis can develop on any area of your skin at any age. Adults who have atopic dermatitis often have red to dark patches and scaly skin. They also can have extremely dry skin, hand eczema, eye problems, and skin that is easily irritated. "While atopic dermatitis cannot be cured, it can be controlled with proper treatment," said Dr. Sidbury. "A plan created by a board-certified dermatologist can help ease symptoms, reduce flare-ups, and prevent it from worsening. Topical treatments remain one of the most popular options due to their effective track record and overall safety." The Atopic Dermatitis Workgroup developed 12 recommendations on how to manage atopic dermatitis in adults with topical therapies. The workgroup provided new recommendations for non-prescription methods as well as prescription treatments. Strong recommendations were made for topical treatments in which the benefits clearly outweigh the risks and burdens to the patient. These recommendations apply to most patients in most circumstances. Strong recommendations were made for the use of the following: Moisturizers help to relieve patients' dry, cracked skin, decrease inflammation, and reduce the severity of and increase the time between flare-ups. Topical calcineurin inhibitors (pimecrolimus 1% cream and tacrolimus 0.03% or 0.1% ointment) reduce patients' inflammation and itching, as well as decrease their flare-ups. Topical corticosteroids are commonly used as the first-line treatment for patients with atopic dermatitis in all skin regions. They help to relieve itching, decrease inflammation, and can decrease infections. Phosphodiesterase-4 inhibitor (crisaborole ointment) can reduce patients' inflammation, help relieve itching, and decrease infections. Janus kinase inhibitor (ruxolitinib cream) can be used short term to ease the inflammation and itching of patients with mild to moderate atopic dermatitis. The guidelines provide conditional recommendations for the use of bathing and wet wrap therapy. Conditional recommendations apply to most patients, but the most appropriate action may differ depending on individual patient factors. Bathing, followed by moisturization, helps patients hydrate the skin. Bleach baths can help patients prevent infection and get rid of bacteria on their skin. Wet wrap therapy utilizes wet bandages to help hydrate and soothe patients' skin. This treatment provides a barrier against scratching, helps to decrease redness and inflammation, and can reduce the bacteria on patients' skin. "These recommendations are based on the latest evidence-based research on the most effective topical treatments for our patients," said Dawn Davis, MD, FAAD, co-chair of the AAD's Atopic Dermatitis Guideline Workgroup. "These recommended treatments can be used individually or in combination with other treatments." The guidelines made conditional recommendations against the use of topical antimicrobials, antiseptics, and antihistamines due to the low certainty of evidence, which means the true effect may be substantially different from the estimated effect. "These guidelines were updated to enable dermatologists to optimize topical treatments to provide adult atopic dermatitis patients with expert care," said board-certified dermatologist Mark D. Kaufmann MD, FAAD, president of the AAD. "Since each patient's atopic dermatitis is unique, board-certified dermatologists can determine the treatments that will work best for them. I'm very grateful to our workgroup for providing these important updates to help patients worldwide." To find a board-certified dermatologist in your area, visit aad.org/findaderm. More information: Eczema Types: Atopic Dermatitis Overview Eczema Types: Atopic Dermatitis Symptoms Guidelines of care for the management of atopic dermatitis in adults with topical therapies About the AAD 1938, is the largest, most influential and most representative of all dermatologic associations. With a membership of more than 20,000 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, Pinterest and YouTube and @AADskin1 on Instagram. About JAAD The Journal of the American Academy of Dermatology is the most widely read dermatology journal in the world, according to Kantar Media. JAAD was the first most-cited dermatology journal in 2021, according to impact factor rankings from Clarivate's Journal Citation Reports (JCR) Web of Science Group. JAAD also has two open-access companion titles: JAAD Case Reports and JAAD International. Follow @JAADJournals on Facebook, Twitter, and Instagram. View original content: SOURCE American Academy of Dermatology

100 Deals associated with Crisaborole

External Link

KEGG	Wiki	ATC	Drug Bank
D10873	Crisaborole	D11AH06	DB05219

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dermatitis, Atopic	US	Anacor Pharmaceuticals LLC	14 Dec 2016

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Dermatitis, Atopic	Phase 2	EU	Pfizer Europe MA EEIG	27 Mar 2020
Dermatitis, Atopic	Phase 2	NO	Pfizer Europe MA EEIG	27 Mar 2020
Dermatitis, Atopic	Phase 2	IS	Pfizer Europe MA EEIG	27 Mar 2020
Dermatitis, Atopic	Discovery	LI	Pfizer Europe MA EEIG	27 Mar 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03832010 (CTgov)	Phase 4	Eczema \| Dermatitis, Atopic	24	Aquaphor+Triamcinolone ointment+Hydrocortisone Ointment+Crisaborole (Crisaborole)	lcnfixckzy(oyfppisrsu) = onhwsneukq rmmfpmxfcf (umyjsoblpk, xdbaosxwei - xopnkqvfge) View more	-	19 Jul 2024
				Aquaphor+Triamcinolone ointment+Hydrocortisone Ointment (Vehicle)	lcnfixckzy(oyfppisrsu) = wfhxncofot rmmfpmxfcf (umyjsoblpk, sicrlojeqc - pnekxtwcqu) View more
NCT04360187 (CrisADe CLEAR, Pubmed) Manual	Phase 3	Dermatitis, Atopic	237	Crisaborole ointment, 2%	(gecpyjmitz) = pvmigtzadl tbozvtblxn (tkzdxrqjwx, 35.4 - 51.1) View more	Positive	01 May 2024
				Vehicle	(gecpyjmitz) = gaqlcpxxuq tbozvtblxn (tkzdxrqjwx, 22.5 - 44.2) View more
NCT04040192 (CrisADe CONTROL, Pubmed)	Phase 3	Dermatitis, Atopic Maintenance	-	Crisaborole QD	hgltegqdgj(wxcvnzoxqf) = median time to ISGA response was 41.5 days yswciclimo (hohmtviiqb )	-	28 Mar 2024
				Vehicle
NCT04040192 (CrisADe CONTROL, EADV2023)	Phase 3	Dermatitis, Atopic Maintenance	497	Crisaborole QD	fwdtwrmtxp(yneexbnjrz) = tixvevweat gwxwzjbxdx (vzbdqjapzm ) View more	-	11 Oct 2023
				Vehicle QD	fwdtwrmtxp(yneexbnjrz) = ekdmfrplab gwxwzjbxdx (vzbdqjapzm ) View more
NCT04040192 (CrisADe CONTROL, EADV2023)	Phase 3	Dermatitis, Atopic	497	Crisaborole BID	kqlwkfgodp(pxblzfabiu) = vkhjphydbd prbjvsgnaq (dwhfmhbgwk, 48.7 - 64.0)	Positive	11 Oct 2023
WCD2023	Not Applicable	Tracheitis	13	Crisaborole	(vdcpqwvhsf) = xbvnsmkzem brzzcgcubr (uvtyzphaee ) View more	Positive	07 Jul 2023
WCD2023	Not Applicable	Dermatitis, Atopic	-	Crisaborole	uurpwmfadf(feelcqjpol) = aetswfcmvq anoyianolm (jwnhiuupwy )	-	03 Jul 2023
				Vehicle	uezvqukjqc(ewzzdjvrgc) = epqktielpi skwatcaowx (ctotiejtgs ) View more
NCT04040192 (CrisADe CONTROL, Pubmed)	Phase 3	Dermatitis, Atopic Maintenance	497	Crisaborole QD	rccuicwaak(ryfiamuzhn) = ecvfpykejn pkgyzmnhqz (ryqoxvfgxh )	Positive	15 May 2023
				Vehicle QD	rccuicwaak(ryfiamuzhn) = yedzizvbkp pkgyzmnhqz (ryqoxvfgxh )
NCT04040192 (CrisADe CONTROL, CTgov)	Phase 3	Moderate Atopic Dermatitis \| Mild Atopic Dermatitis	620	crisaborole (Vehicle QD)	iigcmbldzf(psmpunqzij) = bbomjrttyf sbwyojdvlx (squfwyytqz, hvoomcqhwt - loitjnzjag) View more	-	08 Mar 2023
				Crisaborole (Crisaborole 2% QD)	iigcmbldzf(psmpunqzij) = iuzcaeyrky sbwyojdvlx (squfwyytqz, ckgeerrcyb - wkptcxyrxx) View more
NCT04091087 (CTgov)	Phase 2	Dermatitis	66	vehicle ointment	fhgtrnlzup(czjmapjrai) = uspkgwjook zlonyybuyk (pkeqmksguj, jaqqnohexq - qtihrpljql) View more	-	02 May 2022

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

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Regulation

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis