PMID- 31641421
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200929
IS  - 1941-2789 (Print)
IS  - 1941-2789 (Linking)
VI  - 12
IP  - 9
DP  - 2019 Sep
TI  - Novel Tretinoin 0.05% Lotion for the Once-daily Treatment of Moderate-to-severe 
      Acne Vulgaris in a Preadolescent and Adolescent Population.
PG  - E57-E61
AB  - Background: The efficacy of tretinoin is well documented in adolescent acne, with 
      limited data available in preadolescents. A novel tretinoin 0.05% lotion 
      formulation has been shown to be effective and well tolerated in 
      moderate-to-severe acne. Objective: We sought to evaluate the safety and efficacy 
      of tretinoin 0.05% lotion in preadolescent (</=13 years) and adolescent (14-17 
      years) subjects with acne. Methods: This study involved the post-hoc analysis of 
      two multicenter, randomized, double-blind, vehicle-controlled Phase III studies. 
      Preadolescent (n=154) and adolescent (n=575) subjects were randomized (1:1) to 
      tretinoin 0.05% lotion or vehicle used once daily for 12 weeks. Efficacy 
      assessments included lesion count reductions, treatment success (at least a 
      two-grade reduction in the Evaluator's Global Severity Score and clear/almost 
      clear). Safety, adverse events (AEs), and cutaneous tolerability were evaluated. 
      Results: At Week 12, mean percent reductions in inflammatory and noninflammatory 
      lesion counts were 49.5% and 44.0% in preadolescents and 50.5% and 41.2% in 
      adolescents, compared to 31.4%, 18.8%, 35.9%, and 23.8% for the vehicle, 
      respectively (all p</=0.001). Treatment success was achieved by 23.7% 
      (preadolescent) and 17.5% (adolescent) of subjects by Week 12, compared to 7.2% 
      (p=0.009) and 8.8% (P=0.004) with the vehicle. The majority of AEs were mild and 
      transient; the most frequent occurrences were application site pain and dryness 
      in 5.6% and 2.8% of preadolescents and 3.2% and 3.6% of adolescents. Local 
      cutaneous safety and tolerability assessments were generally mild-to-moderate, 
      with slight transient increases in mean scores at Week 4. Conclusions: Tretinoin 
      0.05% lotion was significantly more effective than the vehicle in achieving 
      treatment success and reducing inflammatory and noninflammatory lesions in 
      preadolescent and adolescent acne. It was well tolerated, and all 
      treatment-related AEs were mild or moderate.
CI  - Copyright (c) 2019. Matrix Medical Communications. All rights reserved.
FAU - St Surin-Lord, Sharleen
AU  - St Surin-Lord S
AD  - Dr. St. Surin-Lord is with Visage Dermatology and Aesthetics Center in Largo, 
      Maryland.
AD  - Dr. Schlesinger is with the Clinical Research Center of the Carolinas in 
      Charleston, South Carolina.
AD  - Dr. Guenin is with Ortho Dermatologics in Bridgewater, New Jersey.
FAU - Schlesinger, Todd E
AU  - Schlesinger TE
AD  - Dr. St. Surin-Lord is with Visage Dermatology and Aesthetics Center in Largo, 
      Maryland.
AD  - Dr. Schlesinger is with the Clinical Research Center of the Carolinas in 
      Charleston, South Carolina.
AD  - Dr. Guenin is with Ortho Dermatologics in Bridgewater, New Jersey.
FAU - Guenin, Eric
AU  - Guenin E
AD  - Dr. St. Surin-Lord is with Visage Dermatology and Aesthetics Center in Largo, 
      Maryland.
AD  - Dr. Schlesinger is with the Clinical Research Center of the Carolinas in 
      Charleston, South Carolina.
AD  - Dr. Guenin is with Ortho Dermatologics in Bridgewater, New Jersey.
LA  - eng
PT  - Journal Article
DEP - 20190901
PL  - United States
TA  - J Clin Aesthet Dermatol
JT  - The Journal of clinical and aesthetic dermatology
JID - 101518173
PMC - PMC6777705
OTO - NOTNLM
OT  - Acne vulgaris
OT  - adolescent
OT  - moderate
OT  - preadolescent
OT  - severe
OT  - topical
OT  - tretinoin
COIS- FUNDING:Ortho Dermatologics funded the preparation of this manuscript. 
      DISCLOSURES:Dr. St. Surin-Lord is a paid consultant for Bausch Health. Dr. Guenin 
      is and employee of Ortho Dermatologics. Dr. Schlesinger has no conflicts of 
      interest relevant to the content of this article.
EDAT- 2019/10/24 06:00
MHDA- 2019/10/24 06:01
PMCR- 2019/09/01
CRDT- 2019/10/24 06:00
PHST- 2019/10/24 06:00 [entrez]
PHST- 2019/10/24 06:00 [pubmed]
PHST- 2019/10/24 06:01 [medline]
PHST- 2019/09/01 00:00 [pmc-release]
PST - ppublish
SO  - J Clin Aesthet Dermatol. 2019 Sep;12(9):E57-E61. Epub 2019 Sep 1.