Topical application of calcipotriol for preventive treatment of hypertrophic scars: a randomized, double-blind, placebo-controlled trial

Completed

Conditions: Hypertrophic scars, keloidsLittekenhypertrofie

Registration Number: NL-OMON27742

Lead Sponsor: VU University Medical Center, Amsterdam.This investigation was supported by a grant of the Dutch Burns Foundation and the Cornelis Visser Foundation.

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

Women aged above 18 years that were planned for bilateral reduction mammoplasty at the University Medical Center of Groningen received written information about the study prior to surgery.

Exclusion Criteria

Exclusion criteria for participation were current or planned pregnancy in the first year following surgery and postoperative complications (e.g. haematoma, infection).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluations took place under standardized circumstances at 3 weeks, 3 months and 12 months following surgery and were performed by the same observer (IEW). <br />During all evaluations, the scar’s clinical aspect was scored as normotrophic (when flat) or hypertrophic (when raised above surrounding skin level). Scoring and measuring was done at 3 cm from the scars lateral and medial extremes.<br /><br>To quantify the scar’s macroscopic properties, its thickness was measured ultrasonographically at 3 and 12 months postoperative, using a 7,5 MHz-probe (SSD-680 EX/STD, Aloka Co., Ltd., Japan). In order to obtain a reliable image, a gel pad (Aquaflex®, Parker Laboratories Inc., Fairfield, USA) was placed between the probe and the skin. The distance (in mm) between the echogenic stratum corneum and subcutaneous tissue (appearing as a ‘black circle’) was measured. This method has proven to be valuable in the morphological assessment of the skin, but also in distinguishing normal from hypertrophic scars.<br>

Secondary Outcome Measures