Back to Search
Start Over
Novel tretinoin 0.05% lotion for the once-daily treatment of moderate-to-severe acne vulgaris in a preadolescent population.
- Source :
-
Pediatric dermatology [Pediatr Dermatol] 2019 Mar; Vol. 36 (2), pp. 193-199. Date of Electronic Publication: 2019 Jan 18. - Publication Year :
- 2019
-
Abstract
- Background: Acne vulgaris (acne) is a common skin condition in children and adolescents. Efficacy of tretinoin is well documented in studies that included pediatric patients (12-18 years of age). With acne routinely presenting in younger patients, data are needed in this important group. Lotion formulations are commonly used across dermatology and are well liked by patients.<br />Objective: To evaluate the safety and efficacy of a novel once-daily tretinoin 0.05% lotion in preadolescent subjects (≤ 13 years) with moderate-to-severe acne.<br />Methods: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies in moderate-to-severe acne. Preadolescent subjects (N = 154) randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory/noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator's Global Severity Score [EGSS] and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability evaluated throughout.<br />Results: At Week 12, mean percent reduction in inflammatory and noninflammatory lesion counts were 49.5% and 44.0% compared with 31.4% and 18.8% with vehicle (both P = 0.001). Treatment success was achieved by 23.7% of subjects by Week 12, compared with 7.2% (P = 0.009). The majority of AEs were mild and transient: most frequently were application site pain (5.6%) and application site dryness (2.8%). Local cutaneous safety and tolerability assessments were generally mild-to-moderate and improved by Week 12.<br />Conclusions: Tretinoin 0.05% lotion was significantly more effective than vehicle in achieving treatment success and reducing inflammatory and noninflammatory lesions in preadolescent acne. It was well tolerated, with all treatment-related AEs deemed mild or moderate.<br /> (© 2019 The Authors. Pediatric Dermatology Published by Wiley Periodicals, Inc.)
- Subjects :
- Administration, Cutaneous
Adolescent
Child
Double-Blind Method
Female
Humans
Keratolytic Agents adverse effects
Male
Patient Satisfaction statistics & numerical data
Quality of Life
Severity of Illness Index
Skin pathology
Treatment Outcome
Tretinoin adverse effects
Acne Vulgaris drug therapy
Keratolytic Agents administration & dosage
Tretinoin administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1525-1470
- Volume :
- 36
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Pediatric dermatology
- Publication Type :
- Academic Journal
- Accession number :
- 30656753
- Full Text :
- https://doi.org/10.1111/pde.13744