PMID- 24918561
OWN - NLM
STAT- MEDLINE
DCOM- 20150209
LR  - 20140612
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 13
IP  - 6
DP  - 2014 Jun
TI  - Cutaneous tolerability to tretinoin shows little variation with Fitzpatrick skin 
      type.
PG  - 706-11
AB  - Determinants of skin irritability are poorly understood. This study aims to 
      assess differences in cutaneous safety/irritation based on Fitzpatrick skin type 
      among patients with acne treated with tretinoin gel microsphere (TGM). This was a 
      phase 4, 12-week, prospective, nonrandomized, open-label, multicenter study. 
      Approximately 500 patients with mild to moderate acne were treated with TGM 0.04% 
      or 0.1% and assessed for cutaneous irritation at baseline and weeks 3, 6, and 12. 
      In this post hoc analysis of patients with Fitzpatrick skin type I-III vs 
      Fitzpatrick skin type IV-VI, there was a general trend toward initial worsening 
      of cutaneous adverse events (AEs) by week 3 across all variables and groups. This 
      was followed by a trend toward improvement and resolution of skin-related AEs 
      from week 3 to week 12 regardless of Fitzpatrick skin type, with a few 
      exceptions. Erythema was the only cutaneous AE that consistently decreased among 
      patients with darker skin. Results from a subsequent 3-group analysis 
      (Fitzpatrick I-II vs Fitzpatrick III-IV vs Fitzpatrick V-VI) generally mirrored 
      those from the 2-group study. Study limitations include patient nonadherence, 
      lack of a placebo arm, and lack of data regarding the impact of concurrent 
      medications on outcomes. There was no correlation between irritation and 
      Fitzpatrick skin type. ABBREVIATIONS USED: adverse event (AE), analysis of 
      variance (ANOVA), benzoyl peroxide (BP), case report form (CRF), modified Global 
      Acne Grading Score (mGAGS), tretinoin gel microsphere (TGM).
FAU - Webster, Guy F
AU  - Webster GF
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Dermatologic Agents)
RN  - 0 (Gels)
RN  - 5688UTC01R (Tretinoin)
SB  - IM
MH  - Acne Vulgaris/*drug therapy
MH  - Administration, Cutaneous
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Dermatologic Agents/administration & dosage/*adverse effects/therapeutic use
MH  - Erythema/*chemically induced/epidemiology
MH  - Female
MH  - Gels
MH  - Humans
MH  - Male
MH  - Microspheres
MH  - Prospective Studies
MH  - Skin Pigmentation
MH  - Time Factors
MH  - Tretinoin/administration & dosage/*adverse effects/therapeutic use
MH  - Young Adult
EDAT- 2014/06/12 06:00
MHDA- 2015/02/11 06:00
CRDT- 2014/06/12 06:00
PHST- 2014/06/12 06:00 [entrez]
PHST- 2014/06/12 06:00 [pubmed]
PHST- 2015/02/11 06:00 [medline]
AID - S1545961614P0706X [pii]
PST - ppublish
SO  - J Drugs Dermatol. 2014 Jun;13(6):706-11.