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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27742
Enrollment
35
Registered
2008-10-09
Start date
2002-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic scars, keloids Littekenhypertrofie

Interventions

Ten days following surgery (after reepithelialization had been established), participants received a pair of ointment packages, marked ‘R’ and ‘L’, which were kindly provided by Leo Pharmaceutical Pro

Sponsors

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

Eligibility

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Evaluations took place under standardized circumstances at 3 weeks, 3 months and 12 months following surgery and were performed by the same observer (IEW). 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. 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.

Secondary

MeasureTime frame
During all evaluations 3 mm punch biopsies were collected, consecutively at 5 cm, 4 cm and 3 cm from the lateral confines of both lateral scars after local anaesthesia with 5 ml lidocaine HCL (10 mg/ml) combined with epinephrine (0.01 mg/ml). Prior to immunohistochemical staining, the frozen biopsy samples were further processed into 5 ìm cryostat sections, embedded on glass slides. Monoclonal antibodies were used for staining the sections. The number of epidermal layers (acanthosis) was counted in the haematoxylin-eosin stained sections. The percentage of proliferating basal keratinocytes was evaluated in anti-Ki-67 stained sections, by counting both the total number of basal keratinocytes (heamatoxilin-stained) and the number of Ki-67-positive basal keratinocytes. The presence or absence of activated keratinocytes was evaluated in anti-keratin-16 stained sections, by scoring suprabasal staining as absent or present. The percentage of epidermal Langerhans cells was calculated using computer-assisted microscopic evaluation using NIS-Elements AR, version 2.3 (Nikon Inc.). After a representative part of the epidermis was outlined, running from basal membrane to stratum corneum, the surface area of CD1a-positive tissue within the selection was expressed as a percentage of the total area in the selection.

Contacts

Public ContactF.B. Niessen

VU University Medical Center Department of Plastic and Reconstructive Surgery PO Box 7057

fb.niessen@vumc.nl+31 (0)20 4443261

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)