Novel tretinoin 0.05% lotion for the once-daily treatment of moderate-to-severe acne vulgaris: assessment of safety and tolerability in subgroups

Background: Topical tretinoin's role in acne has been established through evidence-based guidelines. Cutaneous irritation and potential to cause or exacerbate postinflammatory hyperpigmentation (PIH) may limit use. Objective: Evaluate safety and tolerability of novel polymeric formulation of tr...

Full description

Saved in:
Bibliographic Details
Published in:The Journal of dermatological treatment 2020-02, Vol.31 (2), p.160-167
Main Authors: Harper, Julie C, Roberts, Wendy E, Zeichner, Joshua A, Guenin, Eric, Bhatt, Varsha, Pillai, Radhakrishnan
Format: Article
Language:English
Subjects:
Acne
Acne Vulgaris - drug therapy
Acne Vulgaris - pathology
Adolescent
Adult
Child
Double-Blind Method
Drug Administration Schedule
Drug Tolerance
Female
Humans
Hyperpigmentation - pathology
Keratolytic Agents - therapeutic use
Male
Middle Aged
Pain - etiology
Placebo Effect
polymeric emulsion
Pruritus - pathology
Severity of Illness Index
tolerability
Treatment Outcome
tretinoin
Tretinoin - therapeutic use
Young Adult
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Background: Topical tretinoin's role in acne has been established through evidence-based guidelines. Cutaneous irritation and potential to cause or exacerbate postinflammatory hyperpigmentation (PIH) may limit use. Objective: Evaluate safety and tolerability of novel polymeric formulation of tretinoin 0.05% lotion in moderate-to-severe acne. Methods: One thousand six hundred and forty patients randomized to tretinoin 0.05% lotion or vehicle in two double-blind placebo-controlled 12-week studies. Investigator-evaluated cutaneous safety (erythema and scaling) and patient-reported tolerability (itching, burning/stinging) assessed using a scale of 0 (none) to 3 (severe). Hyper- and hypo-pigmentation evaluated at each study visit. A number of subpopulations were investigated. Results: Tretinoin 0.05% lotion was considered safe and very well tolerated. Only application site pain (3.1%), dryness (3.7%) and erythema (1.4%) were reported by >1% or patients. Treatment-related adverse events were particularly rare (≤2%) in Hispanic and male subpopulations, and lower in adult females. The severity of cutaneous safety and tolerability scores remained
ISSN:0954-6634
1471-1753
DOI:10.1080/09546634.2019.1587884