Efficacy of Verapamil/ Verapamil-Kenacort injection versus Kenacort injection in Scar Treatment

Phase 2

Completed

Conditions: hypertrophic/keloid scar
raised scar
10014982
10040795

Registration Number: NL-OMON43777

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

- Hypertrophic scar
Definition: Excessive overgrowth of dense collagen tissue, often red, pink, or purple in appearance, at the site of a healed skin defect. It resembles a keloid but is usually
temporary, most often regresses without treatment, and remains confined to the site of injury.( http://medical-dictionary.thefreedictionary.com/hypertrophic+scarring)
- Keloid scar
Definition: A nodular, firm, often linear mass of hypertrophic thickish scar tissue,
consisting of irregularly distributed bands of collagen; occurs in the dermis, usually
after trauma, surgery, burn, or a severe cutaneous disease. (http://medicaldictionary.thefreedictionary.com/keloid)
- >= 18 years old

Exclusion Criteria

- Hypertrophic or keloid scar on ear and scalp
- Hypertrophic or keloid scar with a treatment history of radio-, brachy- or cryotherapy, or steroid- or other intralesional therapies in the passed year
- Allergy or intolerance to corticosteroids or Verapamil
- Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the difference in volume of the hypertrophic or<br /><br>keloid scar, measured by a three-dimensional volume measurement technique using<br /><br>the Vectra XT 3D imaging system. (Canfield Imaging Systems, Fairfield, N.J.) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The first secondary study endpoint is difference in POSAS score. The POSAS<br /><br>consists of two parts: a Patient Scale and an Observer Scale. The other<br /><br>secondary study endpoint is the occurrence of any complications/side effects. </p><br>