Delving into the Latest Updates on Fluocinolone Acetonide/Hydroquinone/Tretinoin with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Hydroquinone/tretinoin/fluocinolone-acetonide, Tri-Luma

Target

GR x RARα x RARβ2 x RARγ x TYRP1

Action

agonists, inhibitors

Mechanism

GR agonists(Glucocorticoid receptor agonists), RARα agonists(Retinoic acid receptor alpha agonists), RARβ2 agonists(Retinoic acid receptor beta agonists)

+ [2]

Therapeutic Areas

Skin and Musculoskeletal DiseasesOther Diseases

Active Indication

Melanosis

Inactive Indication

Lentigo

Originator Organization

Galderma International SAS

Active Organization

Galderma Laboratories LP

Inactive Organization

Zhejiang Funuo Pharmaceutical Co. Ltd.

Drug Highest PhaseApproved

First Approval Date

United States (18 Jan 2002),

Melanosis

Regulation-

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Structure/Sequence

Molecular FormulaC24H30F2O6

InChIKeyFEBLZLNTKCEFIT-VSXGLTOVSA-N

CAS Registry67-73-2

View All Structures (3)

主要目的：评价维氟醌乳膏治疗中、重度黄褐斑的疗效和安全性。次要目的：以临床终点方法评价维氟醌乳膏与参比制剂的临床等效性；通过监测临床试验中维A酸、氟轻松、氢醌三种成分的系统吸收，明确受试制剂与参比制剂的系统暴露情况。

[Translation]

Primary objective: To evaluate the efficacy and safety of fluocinolone cream in the treatment of moderate to severe chloasma. Secondary objective: To evaluate the clinical equivalence of fluocinolone cream and the reference preparation by clinical endpoint method; to clarify the systemic exposure of the test preparation and the reference preparation by monitoring the systemic absorption of the three components of retinoic acid, fluocinolone acetonide and hydroquinone in clinical trials.

Start Date14 Oct 2020

Sponsor / Collaborator

Zhejiang Funuo Pharmaceutical Co. Ltd.

CTRI/2018/01/011403

/ CompletedPhase 4

Evaluation of â??Quality of Lifeâ?? and in-use tolerance in women with facial melasma, after using a triple combination drug (TRI-LUMA Cream)

Start Date05 Feb 2018

Sponsor / Collaborator

Galderma India Pvt Ltd.

NCT01778179

/ CompletedNot ApplicableIIT

Safety and Efficacy of a Triple Combination Cream as Adjuvant Treatment of Solar Lentigines With Cryotherapy.

To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy.

Start Date01 Apr 2011

Sponsor / Collaborator-

100 Clinical Results associated with Fluocinolone Acetonide/Hydroquinone/Tretinoin

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100 Translational Medicine associated with Fluocinolone Acetonide/Hydroquinone/Tretinoin

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100 Patents (Medical) associated with Fluocinolone Acetonide/Hydroquinone/Tretinoin

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3

Literatures (Medical) associated with Fluocinolone Acetonide/Hydroquinone/Tretinoin

01 Nov 2016·Journal of drugs in dermatology : JDDQ4 · MEDICINE

The Efficacy of Q-Switched ND:YAG 1064 nm Laser in Recalcitrant Macular Amyloidosis: A Case Report.

Q4 · MEDICINE

Article

Author: Khurana, Nevil ; Urman, Christine

Macular amyloidosis typically presents as small, dusky-brown or greyish pigmented macules, the result of altered keratin deposition. Treatment of these hyperpigmented regions with topical and systemic therapies remains challenging, however Q-Switched neodymi- um-doped yttrium aluminum garnet (ND:YAG) laser has proven to be an effective treatment modality to reduce hyperpigmentation. In this case report we investigated the ef cacy of Q-Switched Nd:YAG laser treatment on a 34-year old woman with recalcitrant macular amyloidosis who failed to respond to over-the-counter bleaching creams. The patient was treated with 7 treatment sessions of Q- Switched Nd:YAG laser at one month intervals. According to our photographic analysis and patient self-assessment, the patient ap- peared to improve with each treatment session. Post-recurrence of the lesion after reaction to Triluma ( uocoinolone actetonide 0.01%, hydroquinone 4%, tretinoin 0.05%), the patient has been continuing to respond well to a second round of treatment with Q-switched Nd:YAG laser at 1064 nm. J Drugs Dermatol. 2016;15(11):1456-1458..

01 Jan 2016·Skin therapy letter

Melasma and Post Inflammatory Hyperpigmentation: Management Update and Expert Opinion.

Review

Author: Prado, G ; Sofen, B ; Emer, J

Dyschromia is a leading cause for cosmetic consultation, especially in those with diverse skin types (mixture of ethnicities) and with the rise of non-core and untrained physicians performing cosmetic procedures. Melasma and post-inflammatory hyperpigmentation (PIH) account for the majority of cases and are characterized by pigmented macules and patches distributed symmetrically in sun-exposed areas of the forehead, cheeks, and chin in melasma, and irregularly in areas of inflammation or an inciting traumatic event with PIH. Treatment is challenging and focused on a variety of mechanisms to stop, hinder, and/or prevent steps in the pigment production (melanocytic hyperactivity) process, breaking down deposited pigment for internal removal or external release, exfoliating cells to enhance turnover, and decreasing inflammation. Topical lightening therapy in combination with sun protection is essential for potential improvement. The most commonly prescribed and researched topical lightening agents are hydroquinone (HQ), azelaic acid (AzA), and retinoids - although only HQ and a triple combination cream (Tri-Luma®; fluocinolone acetonide 0.01%, HQ 4%, tretinoin 0.05%) are US FDA-approved for "bleaching of hyperpigmented skin" (HQ) and "melasma" (Tri-Luma®). Numerous non-HQ brightening/lightening agents, including antioxidant and botanical cosmeceuticals, have recently flooded the market with improvements that claim less irritant potential, as well as avoiding the stigmata associated with HQ agents such as carcinogenesis and cutaneous ochronosis. Combining topical therapy with procedures such as chemical peels, intense pulsed light (IPL), fractional non-ablative lasers or radiofrequency, pigment lasers (microsecond, picosecond, Q-switched), and microneedling, enhances results. With proper treatment, melasma can be controlled, improved, and maintained; alternatively, PIH can be cured in most cases. Herein, we review treatments for both conditions and provide an opinion on proper management for enhanced results.

01 Apr 2004·Methods and findings in experimental and clinical pharmacology

Gateways to clinical trials.

Author: Prous, J R ; Rabasseda, X ; Bayés, M

Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies Knowledge Area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: ABI-007, adalimumab, adefovir dipivoxil, alefacept, alemtuzumab, 3-AP, AP-12009, APC-8015, L-Arginine hydrochloride, aripiprazole, arundic acid, avasimibe; Bevacizumab, bivatuzumab, BMS-181176, BMS-184476, BMS-188797, bortezomib, bosentan, botulinum toxin type B, BQ-123, BRL-55730, bryostatin 1; CEP-1347, cetuximab, cinacalcet hydrochloride, CP-461, CpG-7909; D-003, dabuzalgron hydrochloride, darbepoetin alfa, desloratadine, desoxyepothilone B, dexmethylphenidate hydrochloride, DHA-paclitaxel, diflomotecan, DN-101, DP-b99, drotrecogin alfa (activated), duloxetine hydrochloride, duramycin; Eculizumab, Efalizumab, EKB-569, elcometrine, enfuvirtide, eplerenone, erlotinib hydrochloride, ertapenem sodium, eszopiclone, everolimus, exatecan mesilate, ezetimibe; Fenretinide, fosamprenavir calcium, frovatriptan; GD2L-KLH conjugate vaccine, gefitinib, glufosfamide, GTI-2040; Hexyl insulin M2, human insulin, hydroquinone, gamma-Hydroxybutyrate sodium; IL-4(38-37)-PE38KDEL, imatinib mesylate, indisulam, inhaled insulin, ixabepilone; KRN-5500; LY-544344; MDX-210, melatonin, mepolizumab, motexafin gadolinium; Natalizumab, NSC-330507, NSC-683864; 1-Octanol, omalizumab, ortataxel; Pagoclone, peginterferon alfa-2a, peginterferon alfa-2b, pemetrexed disodium, phenoxodiol, pimecrolimus, plevitrexed, polyphenon E, pramlintide acetate, prasterone, pregabalin, PX-12; QS-21; Ragaglitazar, ranelic acid distrontium salt, RDP-58, recombinant glucagon-like peptide-1 (7-36) amide, repinotan hydrochloride, rhEndostatin, rh-Lactoferrin, (R)-roscovitine; S-8184, semaxanib, sitafloxacin hydrate, sitaxsentan sodium, sorafenib, synthadotin; Tadalafil, tesmilifene hydrochloride, theratope, tipifarnib, tirapazamine, topixantrone hydrochloride, trabectedin, traxoprodil, Tri-Luma; Valdecoxib, valganciclovir hydrochloride, vinflunine; Ximelagatran; Ziconotide.

100 Deals associated with Fluocinolone Acetonide/Hydroquinone/Tretinoin

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Melanosis	United States	Galderma Laboratories LP	18 Jan 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Melanosis	Preclinical	China	Zhejiang Funuo Pharmaceutical Co. Ltd.	14 Oct 2020
Lentigo	Preclinical	Chile	-	01 Aug 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01778179 (CTgov)	Not Applicable	Lentigo	50	Cryotherapy (CRY-AC3® device)+Tri-luma (Group 1)	wbcskpzotl(qxrmkquxsp) = irjhoohvwy vlxddmqtvh (gectkkxlci, nwruxckclj - uydxbqflfs) View more	-	17 Sep 2020
				Cryotherapy (CRY-AC3® device) (Group 2)	wbcskpzotl(qxrmkquxsp) = wqgfksmxry vlxddmqtvh (gectkkxlci, jlvewrmbms - rfedkazsxp) View more
NCT00669071 (CTgov)	Phase 4	Melanosis	56	Tri-Luma (Intense Pulsed Light (IPL) / Tri-Luma® Cream)	rziuhalsxe(jerrddsjoz) = xuyqnbjcho lozvjvuvjz (wamrkmbnff, hwvpdmwnln - rqmtxxsdnp) View more	-	11 Jan 2010
				Cetaphil (Intense Pulsed Light (IPL) / Inactive Control Cream)	rziuhalsxe(jerrddsjoz) = huatfwezhb lozvjvuvjz (wamrkmbnff, jleyzsazca - wjbhsimhxu) View more