B S Chandrashekhar1, M Anitha2, Mukesh Ruparelia3, Pradyumna Vaidya4, Riyaz Aamir5, Sunil Shah6, S Thilak7, Sanjeev Aurangabadkar8, Sandeep Pal9, Abir Saraswat10, Jayesh J Sanmukhani11. 1. Consultant Dermatologist, Cutis Clinic , Bangalore, India . 2. Consultant Dermatologist and Cosmetologist, Erode, India . 3. Devarsh Cosmetic Care and Sliming Centre , Rajkot, India . 4. Consultant Dermatologist, Skin & Laser Clinic , Pune, India . 5. Consultant Dermatologist, Skin Care Clinic , Nagpur, India . 6. Consultant Skin specialist, Shriji Skin care Clinic , Ahmedabad, India . 7. Consultant Dermatologist and Cosmetologist, S.V. Clinic , Chennai, India . 8. Consultant Dermatologist, Skin & Laser Clinic , Hyderabad, India . 9. Consultant Hair & Skin Specialist, Orange City Hospital , Nagpur, India . 10. Consultant Dermatologist & Venereologist, Indushree Skin Clinic , Lucknow, India . 11. Clinical Research Department, Cadila Healthcare Ltd ., Ahmedabad, India .
Abstract
BACKGROUND: Conventional topical tretinoin formulation is often associated with local adverse events. Nanogel formulation of tretinoin has good physical stability and enables good penetration of tretinoin into the pilo-sebaceous glands. AIM: The present study was conducted to assess the efficacy and safety of a nanogel formulation of tretinoin as compared to its conventional gel formulation in the treatment of acne vulgaris of the face. MATERIALS AND METHODS: This randomized, active controlled, multicentric, phase IV clinical trial evaluated the treatment of patients with acne vulgaris of the face by the two gel formulations locally applied once daily at night for 12 wk. Acne lesion counts (inflammatory, non-inflammatory & total) and severity grading were carried out on the monthly scheduled visits along with the tolerability assessments. RESULTS: A total of 207 patients were randomized in the study. Reductions in the total (72.9% vs. 65.0%; p = 0.03) and inflammatory (78.1% vs. 66.9%; p = 0.02) acne lesions were reported to be significantly greater with the nanogel formulation as compared to the conventional gel formulation. Local adverse events were significantly less (p = 0.04) in the nanogel group (13.3%) as compared to the conventional gel group (24.7%). Dryness was the most common adverse event reported in both the treatment groups while peeling of skin, burning sensation and photosensitivity were reported in patients using the conventional gel only. CONCLUSION: In the treatment of acne vulgaris of the face, tretinoin nanogel formulation appears to be more effective and better tolerated than the conventional gel formulation.
RCT Entities:
BACKGROUND: Conventional topical tretinoin formulation is often associated with local adverse events. Nanogel formulation of tretinoin has good physical stability and enables good penetration of tretinoin into the pilo-sebaceous glands. AIM: The present study was conducted to assess the efficacy and safety of a nanogel formulation of tretinoin as compared to its conventional gel formulation in the treatment of acne vulgaris of the face. MATERIALS AND METHODS: This randomized, active controlled, multicentric, phase IV clinical trial evaluated the treatment of patients with acne vulgaris of the face by the two gel formulations locally applied once daily at night for 12 wk. Acne lesion counts (inflammatory, non-inflammatory & total) and severity grading were carried out on the monthly scheduled visits along with the tolerability assessments. RESULTS: A total of 207 patients were randomized in the study. Reductions in the total (72.9% vs. 65.0%; p = 0.03) and inflammatory (78.1% vs. 66.9%; p = 0.02) acne lesions were reported to be significantly greater with the nanogel formulation as compared to the conventional gel formulation. Local adverse events were significantly less (p = 0.04) in the nanogel group (13.3%) as compared to the conventional gel group (24.7%). Dryness was the most common adverse event reported in both the treatment groups while peeling of skin, burning sensation and photosensitivity were reported in patients using the conventional gel only. CONCLUSION: In the treatment of acne vulgaris of the face, tretinoin nanogel formulation appears to be more effective and better tolerated than the conventional gel formulation.
Authors: W J Cunliffe; R Caputo; B Dreno; L Förström; M Heenen; C E Orfanos; Y Privat; A Robledo Aguilar; J Meynadier; M Alirezai; S Jablonska; A Shalita; J S Weiss; D K Chalker; C N Ellis; A Greenspan; H I Katz; I Kantor; L E Millikan; J M Swinehart; L Swinyer; C Whitmore; J Czernielewski; M Verschoore Journal: J Am Acad Dermatol Date: 1997-06 Impact factor: 11.527
Authors: Diane Thiboutot; Harald Gollnick; Vincenzo Bettoli; Brigitte Dréno; Sewon Kang; James J Leyden; Alan R Shalita; Vicente Torres Lozada; Diane Berson; Andrew Finlay; Chee Leok Goh; María Isabel Herane; Ana Kaminsky; Raj Kubba; Alison Layton; Yoshiki Miyachi; Montserrat Perez; Jaime Piquero Martin; Marcia Ramos-E-Silva; Jo Ann See; Neil Shear; John Wolf Journal: J Am Acad Dermatol Date: 2009-05 Impact factor: 11.527
Authors: Richard Berger; Ronald Rizer; Alicia Barba; David Wilson; Daniel Stewart; Rachel Grossman; Marge Nighland; Jonathan Weiss Journal: Clin Ther Date: 2007-06 Impact factor: 3.393