PMID- 29750047
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220317
IS  - 1178-7015 (Print)
IS  - 1178-7015 (Electronic)
IS  - 1178-7015 (Linking)
VI  - 11
DP  - 2018
TI  - Skin acceptability of a cosmetic moisturizer formulation in female subjects with 
      sensitive skin.
PG  - 213-217
LID - 10.2147/CCID.S157297 [doi]
AB  - PURPOSE: This 3-week, open-label, noncomparative clinical study evaluated the 
      skin acceptability of a cosmetic moisturizer in subjects with sensitive skin, by 
      monitoring adverse events (AEs) and cutaneous discomfort related to normal usage. 
      MATERIALS AND METHODS: Female subjects aged between 18-60 years, with Fitzpatrick 
      phototype classification I-IV and sensitive skin, verified by a positive reaction 
      on the stinging test at screening, were included. Subjects applied the 
      moisturizer to their face and body twice daily for 21+/-2 days at home and recorded 
      study product usage and feelings of cutaneous discomfort (eg, dryness, prickling, 
      stinging, and itching) in a diary; any AEs were reported to the clinic. At study 
      end, skin acceptability of the moisturizer was investigator-assessed based on the 
      nature of AEs and subjects' self-reported feelings of discomfort, and by clinical 
      evaluation of skin reactions in the area of moisturizer application (appearance 
      of erythema, formation of edema, and skin desquamation; scored according to an 
      adapted Draize and Kligman scale). Only subjects with a treatment compliance of 
      >/=80% were included in the final analysis. RESULTS: In total, 35 subjects 
      initiated and completed the study; all were compliant to the minimum study 
      product usage. Per investigator clinical dermatological assessment at study end, 
      none of the 35 subjects had skin reactions in the area of moisturizer application 
      and there were no reported AEs. One subject reported sensations of mild prickling 
      and itching immediately after applying the moisturizer (not classified as AEs), 
      which spontaneously remitted after complete absorption of the product and were 
      noted only in exposed areas. These events were considered by the investigator as 
      being possibly/probably related to the use of study product; however, no clinical 
      signs of skin reaction were observed in the exposed areas. CONCLUSION: This 
      cosmetic moisturizer appears generally well tolerated and suitable for topical 
      use in subjects with sensitive skin.
FAU - Nisbet, Stephanie J
AU  - Nisbet SJ
AD  - Skin Health Medical Affairs, GSK Consumer Healthcare, Weybridge, Surrey, UK.
LA  - eng
PT  - Journal Article
DEP - 20180430
PL  - New Zealand
TA  - Clin Cosmet Investig Dermatol
JT  - Clinical, cosmetic and investigational dermatology
JID - 101543449
PMC - PMC5933397
OTO - NOTNLM
OT  - irritation
OT  - safety testing
OT  - sensitive skin
OT  - skin acceptability
OT  - skin barrier
COIS- Disclosure Stephanie J Nisbet discloses employment with GSK Consumer Healthcare 
      and stock/share ownership in GSK. The author reports no other conflicts of 
      interest in this work.
EDAT- 2018/05/12 06:00
MHDA- 2018/05/12 06:01
PMCR- 2018/04/30
CRDT- 2018/05/12 06:00
PHST- 2018/05/12 06:00 [entrez]
PHST- 2018/05/12 06:00 [pubmed]
PHST- 2018/05/12 06:01 [medline]
PHST- 2018/04/30 00:00 [pmc-release]
AID - ccid-11-213 [pii]
AID - 10.2147/CCID.S157297 [doi]
PST - epublish
SO  - Clin Cosmet Investig Dermatol. 2018 Apr 30;11:213-217. doi: 10.2147/CCID.S157297. 
      eCollection 2018.