Delving into the Latest Updates on Clindamycin Phosphate/Tretinoin with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Veltin, Ziana

Target

50S subunit x RARα x RARβ2 x RARγ

Mechanism

50S subunit inhibitors(50S ribosomal subunit inhibitors), RARα agonists(Retinoic acid receptor alpha agonists), RARβ2 agonists(Retinoic acid receptor beta agonists)

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Therapeutic Areas

Skin and Musculoskeletal Diseases

Active Indication

Acne Vulgaris

Inactive Indication-

Originator Organization

Medicis Pharmaceutical Corp.

Active Organization

Almirall LLCBausch Health US LLC

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (07 Nov 2006),

Acne Vulgaris

Regulation-

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Structure/Sequence

Molecular FormulaC38H62ClN2O10PS

InChIKeyRRZFQNYMUQPMHE-HYEGCIPRSA-N

CAS Registry337954-93-5

BACKGROUNDA fixed-dose combination of clindamycin phosphate 1.2% and tretinoin 0.025% gel (VELTIN® (clindamycin phosphate and tretinoin) 1.2%/0.025% Gel [VELTIN]) (clindamycin/tretinoin gel) is currently available for the once-daily topical treatment of acne.OBJECTIVESTwo-phase I studies were conducted to evaluate the phototoxic and photoallergic potential of clindamycin/tretinoin gel.METHODSStudy 1 (phototoxic) (n=37) and Study 2 (photoallergic) (n=58) were single-center, evaluator-blinded, randomized, vehicle-controlled, phase 1 studies conducted in healthy volunteers. In Study 1, clindamycin/tretinoin gel patches, vehicle gel patches and blank patches (no gel) were applied concurrently for 24 hours to naïve sites. After patch removal, sites were irradiated with 16 joules/cm2 of ultraviolet A light (UVA) then 0.75 minimal erythema dose (MED) of UVA/ultraviolet B light (UVB), the same irradiation protocol followed by 15 joules/cm2 of visible light (VIS), or served as non-irradiated controls. Study 2 examined the effect of repeated drug exposure and involved an induction period (6 repeat phases at the same body sites during which clindamycin/tretinoin gel and vehicle gel patches were applied for 24 hours, removed and sites irradiated with UVB +/- VIS), followed by a rest period (10 to 17 days), then a challenge period that used the protocol described for Study 1. In both studies, inflammatory responses and other cutaneous effects were evaluated at 1, 24, 48, and 72 hours after patch removal.RESULTSNo subject experienced any adverse events in Study 1 (phototoxic). One subject in Study 2 (photoallergic) experienced AEs (diffuse erythema; mild application site irritation at one each of UV/VIS-irradiated clindamycin/tretinoin gel and vehicle gel patch sites) considered definitely related to study product that resulted in discontinuation from the study. Data from Study 1 and the challenge phase from Study 2 showed most subjects had no visible inflammatory reaction to clindamycin/tretinoin gel after irradiation.CONCLUSIONSClindamycin/tretinoin gel has a favorable safety profile following UV/visible irradiation and a low potential for phototoxicity and photoallergenicity.

29 Dec 2010·The Medical letter on drugs and therapeuticsQ4 · MEDICINE

Clindamycin-tretinoin (veltin gel) for acne.

Q4 · MEDICINE

Review

01 Mar 2007·SKINmed: Dermatology for the Clinician

Ziana (Clindamycin Phosphate 1.2% and Tretinoin 0.025%)Gel

Article

Author: Gover, Melissa D ; Abramovits, William ; Gupta, Aditya K

100 Deals associated with Clindamycin Phosphate/Tretinoin

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	D10AF51	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Acne Vulgaris	US	Bausch Health US LLC	07 Nov 2006

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01047189 (CTgov)	Phase 4	Acne Vulgaris	26	clindamycin phosphate+Ziana gel+tretinoin (Ziana Gel)	otdvnoxhzq(hvetficptr) = yvhktbavra glyrpstwho (mpwktepbvi, sxirnnbnxo - ouhvequnbr) View more	-	17 Oct 2011
				Tretinoin+Clindamycin (Clindamycin Plus Tretinoin Applied Separately)	otdvnoxhzq(hvetficptr) = wbtlefmunm glyrpstwho (mpwktepbvi, dsbnjcusrx - mcwprumkuy) View more
NCT00891982 (CTgov)	Phase 3	Acne Vulgaris	60	CLINDAMYCIN PHOSPHATE/TRETINOIN+Benzoyl Peroxide (CTGel Plus BPO Wash)	ceztugbpup(gfwfatqdqo) = qbbhzdgjdb gestoonqnq (owcudshbqr, xndkdxrjtm - uorhswxjhy) View more	-	25 Jul 2011
				CTGel (CTGel)	ceztugbpup(gfwfatqdqo) = oxrfgknque gestoonqnq (owcudshbqr, mthcbpqodk - aeiwlqcnse) View more