Study of trolamine-containing topical emulsion for wound healing after shave biopsy.
The efficacy and safety of trolamine-containing topical emulsion (Biafine) for enhancing wound healing after shave biopsy were evaluated in a single-center, open-label, single-group study. Fifteen participants applied trolamine-containing topical emulsion twice daily to the entire wound area for 4 weeks. Twelve of 15 participants (80%) completed the study. Wound healing was evaluated at weeks 1, 2, and 4. After 1 week of treatment with trolamine-containing topical emulsion, wound size was reduced by half. Complete healing occurred by week 4. Intention-to-treat (ITT) analysis of the investigators global assessment (IGA) of efficacy (primary end point) over time showed trolamine-containing topical emulsion was moderately to very effective in 80% of participants (12/15) at week 1, 86.7% (13/15) at week 2, and 80% (12/15) at week 4; corresponding figures for the perprotocol analysis were 85.7% (12/14), 100% (13/13), and 100% (12/12), respectively. Treatment was well-tolerated with, mild or moderate application-site signs (ie, erythema, erosion, inflammation, crusting) present during the first 2 weeks of treatment; mild or moderate subjective symptoms (ie, irritation, itchiness, burning, tenderness, pain) were present predominantly during the first 2 weeks of treatment. One participant withdrew from the study because of application-site erythema/burning probably related to trolamine-containing topical emulsion. These data indicate that 4 weeks of treatment with trolamine-containing topical emulsion promotes rapid healing and is safe and well-tolerated in patients who undergo shave biopsies.
Kircik
Leon H
LH
Mount Sinai Medical Center, New York, New York, USA. dermresearch@wedoderm.com
D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001706:Biopsy / Q000009:adverse effects / Q000379:methods; D004655:Emulsions; D004983:Ethanolamines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012867:Skin / Q000187:drug effects* / Q000293:injuries; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*; D055815:Young Adult
D004655:Emulsions; D004983:Ethanolamines; C009546:triethanolamine