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A Randomized, Double-blind, Placebo-Controlled Trial

Willem M. van der Veer, MS; Xander E. Jacobs, MD; Ingmar E. Waardenburg, MD; Magda M. Ulrich, PhD; Frank B. Niessen, MD, PhD

Arch Dermatol. 2009;145(11):1269-1275.

Objectives  To evaluate the efficacy of topical application of calcipotriol to healing wounds in preventing or reducing hypertrophic scar formation and to investigate the biochemical properties of the epidermis associated with hypertrophic scar formation.

Design  Randomized, double-blind, placebo-controlled trial using the reduction mammoplasty wound-healing model.

Setting  University Medical Center Groningen.

Patients  Thirty women who underwent bilateral reduction mammoplasty.

Interventions  For 3 months, scar segments were treated with either topical calcipotriol or placebo.

Main Outcome Measures  Three weeks, 3 months, and 12 months postoperatively, the scars were evaluated and punch biopsy samples were collected for immunohistochemical analysis.

Results  No significant difference in the prevalence of hypertrophic scars was observed between the placebo- and calcipotriol-treated scars. Only scars with activated keratinocytes 3 weeks postoperatively became hypertrophic (P = .001).

Conclusions  Topical application of calcipotriol during the first 3 months of wound healing does not affect the incidence of hypertrophic scar formation. We observed a strong association between keratinocyte activation and hypertrophic scar formation.

Trial Registration  trialregister.nl Identifier: NTR1486

Author Affiliations: Department of Plastic and Reconstructive Surgery, VU University Medical Center, Amsterdam (Mr van der Veer and Drs Jacobs, Ulrich, and Niessen); Department of Plastic and Reconstructive Surgery, University Medical Center Groningen, Groningen (Dr Waardenburg); and Association of Dutch Burn Centers, Beverwijk (Dr Ulrich), the Netherlands.

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