PMID- 30811141
OWN - NLM
STAT- MEDLINE
DCOM- 20190606
LR  - 20190606
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 18
IP  - 2
DP  - 2019 Feb 1
TI  - Novel Tretinoin 0.05% Lotion for the Once-daily Treatment of Moderate-to-Severe 
      Acne Vulgaris in an Adult and Adolescent Female Population.
PG  - 178-188
LID - S1545961619P0178X [pii]
AB  - Background: Acne vulgaris (acne) is a common dermatological condition typically 
      associated with adolescents, affecting about 85% of young people. However, it is 
      also prevalent and persistent into adulthood, particularly in females. The 
      efficacy of tretinoin in acne is well documented with large pivotal studies. The 
      first lotion formulation of tretinoin was developed to provide an important 
      alternative option to treat acne patients who may be sensitive to the irritant 
      effects of other tretinoin formulations. Objective: To determine whether efficacy 
      and safety of tretinoin 0.05% lotion was similar in adolescent (<18 years) and 
      adult (>=18 years) women with moderate-to-severe acne. Methods: Post hoc analysis 
      of two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies 
      in moderate or severe acne. Female subjects (aged 9 to 58 years, N=909) 
      randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 
      weeks. Efficacy assessments included changes in baseline inflammatory and 
      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 were evaluated throughout. Results: At 
      week 12, mean percent reduction in inflammatory and noninflammatory lesion counts 
      in female subjects were 56.9% and 51.7%, respectively, compared with 47.1% and 
      34.9% with vehicle (P=<0.001). Similar results were seen in adult and adolescent 
      females in terms of reduction in inflammatory lesion counts with tretinoin 0.05% 
      lotion; reduction in noninflammatory lesions was significantly greater in adult 
      females (P=0.002). Treatment success was achieved by 23.6% of female subjects by 
      week 12, compared with 13.5% on vehicle (P<0.001). Although treatment success was 
      somewhat greater in adult females (24.6% versus 21.6%), the difference was not 
      significant. The majority of AEs were mild and transient. There were five serious 
      AEs (SAEs) reported (4/1, adult/adolescent, respectively). The most frequently 
      reported treatment related AEs with tretinoin 0.05% lotion were application site 
      pain (3.0%/5.7%), and application site dryness (4.9%/6.4%). Local cutaneous 
      safety and tolerability assessments were generally mild-to-moderate and improved 
      by week 12. Slight increases in mean scores were observed for scaling, burning 
      and stinging within the first four weeks and appeared to be transient. 
      Conclusions: Tretinoin 0.05% lotion was significantly more effective than its 
      vehicle in achieving treatment success and reducing inflammatory and 
      noninflammatory lesions in female acne. Noninflammatory lesion count reduction 
      was significantly greater in adult females compared with adolescent females. The 
      new lotion formulation was well-tolerated. J Drugs Dermatol. 2019;18(2):178-188.
FAU - Kircik, Leon H
AU  - Kircik LH
FAU - Baldwin, Hilary
AU  - Baldwin H
FAU - Lain, Edward
AU  - Lain E
FAU - Guenin, Eric
AU  - Guenin E
FAU - Harris, Susan
AU  - Harris S
FAU - Bhatt, Varsha
AU  - Bhatt V
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Keratolytic Agents)
RN  - 5688UTC01R (Tretinoin)
SB  - IM
MH  - Acne Vulgaris/*diagnosis/*drug therapy
MH  - Administration, Topical
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Compounding
MH  - Female
MH  - Humans
MH  - Keratolytic Agents/*administration & dosage/chemistry
MH  - Middle Aged
MH  - *Severity of Illness Index
MH  - Treatment Outcome
MH  - Tretinoin/*administration & dosage/chemistry
MH  - Young Adult
EDAT- 2019/02/28 06:00
MHDA- 2019/06/07 06:00
CRDT- 2019/02/28 06:00
PHST- 2019/02/28 06:00 [entrez]
PHST- 2019/02/28 06:00 [pubmed]
PHST- 2019/06/07 06:00 [medline]
AID - S1545961619P0178X [pii]
PST - ppublish
SO  - J Drugs Dermatol. 2019 Feb 1;18(2):178-188.