title: Formulation of tretinoin-loaded topical proniosomes for treatment of acne: in-vitro characterization, skin irritation test and comparative clinical study.
abstract: Tretinoin (TRT) is a widely used retinoid for the topical treatment of acne, photo-aged skin, psoriasis and skin cancer which makes it a good candidate for topical formulation. Yet side effects, like redness, swelling, peeling, blistering and, erythema, in addition to its high lipophilicity make this challenging. Therefore, the aim of this study was the development of TRT-loaded proniosomes to improve the drug efficacy and to increase user acceptability and compliance by reducing its side effects. Nine formulae were prepared according to 3(2) factorial design and were evaluated for their morphology, vesicle size, entrapment efficiency (EE %), and% of drug released after 5 h. Hydrogel of the candidate formula, N8G (proniosomes prepared with 0.025% TRT, and Span60: cholesterol molar ratio of 3:1 and incorporated in 1% carbopol gel) was developed and evaluated for skin irritation test and clinical study in acne patients compared to marketed product. Candidate formula showed higher efficacy and very low irritation potential when compared to marketed product in human volunteers.
authors.affiliation: a National Organization of Drug Control and Research (NODCAR) , Cairo , Egypt .
authors.forename: Salwa Abdel
authors.initials: SA
authors.lastname: Rahman
authors.affiliation: b Department of Pharmaceutics, Faculty of Pharmacy , Cairo University .
authors.forename: Nevine Shawky
authors.initials: NS
authors.lastname: Abdelmalak
authors.affiliation: b Department of Pharmaceutics, Faculty of Pharmacy , Cairo University .
authors.forename: Alia
authors.initials: A
authors.lastname: Badawi
authors.affiliation: a National Organization of Drug Control and Research (NODCAR) , Cairo , Egypt .
authors.forename: Tahany
authors.initials: T
authors.lastname: Elbayoumy
authors.affiliation: c Department of Clinical Pharmacy , Faculty of Pharmacy , and.
authors.forename: Nermeen
authors.initials: N
authors.lastname: Sabry
authors.affiliation: d Department of Dermatology, Faculty of Medecine , Cairo University , Cairo , Egypt.
authors.forename: Amany
authors.initials: A
authors.lastname: El Ramly
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000287:Administration, Topical; D000293:Adolescent; D002152:Calorimetry, Differential Scanning; D002626:Chemistry, Pharmaceutical; D002784:Cholesterol / Q000737:chemistry; D004305:Dose-Response Relationship, Drug; D065546:Drug Liberation; D004534:Egypt; D005260:Female; D006801:Humans; D020100:Hydrogels / Q000737:chemistry; D006863:Hydrogen-Ion Concentration; D007641:Keratolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D008081:Liposomes / Q000737:chemistry*; D008297:Male; D046529:Microscopy, Electron, Transmission; D010316:Particle Size; D012869:Skin Absorption; D023422:Skin Irritancy Tests; D013501:Surface-Active Agents / Q000737:chemistry; D014212:Tretinoin / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D055815:Young Adult
chemical_list: D020100:Hydrogels; D007641:Keratolytic Agents; D008081:Liposomes; D013501:Surface-Active Agents; D014212:Tretinoin; D002784:Cholesterol
keywords: Acne patients; Tretinoin; clinical study; proniosomes; skin irritation