Avotermin for scar improvement following scar revision surgery: a randomized, double-blind, within-patient, placebo-controlled, phase II clinical trial.

Abstract

BACKGROUND:

Skin scarring is associated with psychosocial distress and has a negative effect on quality of life. The transforming growth factor (TGF)-β family of cytokines plays a key role in scarring. TGF-β3 improves scar appearance in a range of mammalian species. This study was performed to assess the efficacy of intradermal avotermin (TGF-β3) for the improvement of scar appearance following scar revision surgery.

METHODS:

Sixty patients (35 men and 25 women; age, 19 to 78 years; 53 Caucasians; scar length, 5 to 21 cm) received intradermal avotermin (200 ng/100 μl/linear cm wound margin) and placebo to outer wound segments immediately after, and again 24 hours after, complete (group 1) or staged (group 2) scar revision surgery. A within-patient design was chosen to control for interindividual factors that affect scarring. The primary efficacy variable was a total scar score derived from a visual analogue scale, scored by a lay panel from standardized photographs from months 1 through 7 following treatment.

RESULTS:

: Primary endpoint data from the combined surgical groups showed that avotermin significantly improved scar appearance compared with placebo (total scar score difference, 21.93 mm; p = 0.04). Profilometry showed a greater reduction in scar surface area from baseline with avotermin treatment compared with placebo, significant in group 2 at months 7 and 12 (difference, 41.99 mm and 25.85 mm, respectively; p = 0.03 for both comparisons). Histologic analysis from group 2 showed that, compared with placebo treatment, collagen organization in avotermin-treated scars more closely resembled normal skin in 14 of 19 cases. Avotermin was well tolerated.

CONCLUSION:

Avotermin administration following scar revision surgery is well tolerated and significantly improves scar appearance compared with placebo.

CLINICAL QUESTION/LEVEL OF EVIDENCE:

Therapeutic, I.(Figure is included in full-text article.).

• Authors: Karen So, Duncan A McGrouther, James A Bush, Piyush Durani, Lisa Taylor, Gaynor Skotny, Tracey Mason, Anthony Metcalfe, Sharon O'Kane, Mark W J Ferguson
• Journal: Plastic and reconstructive surgery (Plast Reconstr Surg) Vol. 128 Issue 1 Pg. 163-172 (Jul 2011) ISSN: 1529-4242 [Electronic] United States
• PMID: 21701333 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• TGFB3 protein, human
• Transforming Growth Factor beta3

Topics

• Adult
• Aged
• Cicatrix (prevention & control, surgery)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Reoperation
• Transforming Growth Factor beta3 (therapeutic use)
• Young Adult