Tretinoin Nanogel 0.025% Versus Conventional Gel 0.025% in Patients with Acne Vulgaris: A Randomized, Active Controlled, Multicentre, Parallel Group, Phase IV Clinical Trial.
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.


OBJECTIVE
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.


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.


CONCLUSIONS
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.
Consultant Dermatologist, Cutis Clinic , Bangalore, India .
B S
BS
Chandrashekhar
Consultant Dermatologist and Cosmetologist, Erode, India .
M
M
Anitha
Devarsh Cosmetic Care and Sliming Centre , Rajkot, India .
Mukesh
M
Ruparelia
Consultant Dermatologist, Skin & Laser Clinic , Pune, India .
Pradyumna
P
Vaidya
Consultant Dermatologist, Skin Care Clinic , Nagpur, India .
Riyaz
R
Aamir
Consultant Skin specialist, Shriji Skin care Clinic , Ahmedabad, India .
Sunil
S
Shah
Consultant Dermatologist and Cosmetologist, S.V. Clinic , Chennai, India .
S
S
Thilak
Consultant Dermatologist, Skin & Laser Clinic , Hyderabad, India .
Sanjeev
S
Aurangabadkar
Consultant Hair & Skin Specialist, Orange City Hospital , Nagpur, India .
Sandeep
S
Pal
Consultant Dermatologist & Venereologist, Indushree Skin Clinic , Lucknow, India .
Abir
A
Saraswat
Clinical Research Department, Cadila Healthcare Ltd ., Ahmedabad, India .
Jayesh J
JJ
Sanmukhani
Acne vulgaris; Nanogel; Tretinoin