PMID- 30656753
OWN - NLM
STAT- MEDLINE
DCOM- 20190401
LR  - 20210109
IS  - 1525-1470 (Electronic)
IS  - 0736-8046 (Print)
IS  - 0736-8046 (Linking)
VI  - 36
IP  - 2
DP  - 2019 Mar
TI  - Novel tretinoin 0.05% lotion for the once-daily treatment of moderate-to-severe 
      acne vulgaris in a preadolescent population.
PG  - 193-199
LID - 10.1111/pde.13744 [doi]
AB  - 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. 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. 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. 
      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. 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.
CI  - (c) 2019 The Authors. Pediatric Dermatology Published by Wiley Periodicals, Inc.
FAU - Eichenfield, Lawrence F
AU  - Eichenfield LF
AUID- ORCID: 0000-0002-2760-0474
AD  - Departments of Dermatology and Pediatrics, University of California, San Diego 
      School of Medicine and Rady Children's Hospital, San Diego, California.
FAU - Sugarman, Jeffrey L
AU  - Sugarman JL
AD  - University of California, San Francisco, California.
FAU - Guenin, Eric
AU  - Guenin E
AD  - Ortho Dermatologics, Bridgewater, New Jersey.
FAU - Harris, Susan
AU  - Harris S
AD  - Bausch Health, Bridgewater, New Jersey.
FAU - Bhatt, Varsha
AU  - Bhatt V
AD  - Dow Pharmaceutical Sciences Inc., Petaluma, California.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20190118
PL  - United States
TA  - Pediatr Dermatol
JT  - Pediatric dermatology
JID - 8406799
RN  - 0 (Keratolytic Agents)
RN  - 5688UTC01R (Tretinoin)
SB  - IM
MH  - Acne Vulgaris/*drug therapy
MH  - Administration, Cutaneous
MH  - Adolescent
MH  - Child
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Keratolytic Agents/*administration & dosage/adverse effects
MH  - Male
MH  - Patient Satisfaction/statistics & numerical data
MH  - Quality of Life
MH  - Severity of Illness Index
MH  - Skin/pathology
MH  - Treatment Outcome
MH  - Tretinoin/*administration & dosage/adverse effects
PMC - PMC6590503
OTO - NOTNLM
OT  - acne vulgaris
OT  - preadolescents
OT  - topical
OT  - tretinoin
COIS- LFE and JLS were study investigators and are advisors for Ortho Dermatologics. 
      EG, SH, and VB are employees of Bausch Health.
EDAT- 2019/01/19 06:00
MHDA- 2019/04/02 06:00
PMCR- 2019/06/24
CRDT- 2019/01/19 06:00
PHST- 2019/01/19 06:00 [pubmed]
PHST- 2019/04/02 06:00 [medline]
PHST- 2019/01/19 06:00 [entrez]
PHST- 2019/06/24 00:00 [pmc-release]
AID - PDE13744 [pii]
AID - 10.1111/pde.13744 [doi]
PST - ppublish
SO  - Pediatr Dermatol. 2019 Mar;36(2):193-199. doi: 10.1111/pde.13744. Epub 2019 Jan 
      18.