Evaluation of the Efficacy, Tolerability, and Patient Acceptance of Dermatix Q for the Prevention and Management of Scars

Innovative Medical

Status and phase: Completed; Phase 4

Conditions: Scars

Treatments: Drug: Dermatix Q

Study type: Interventional

Funder types: Industry

Identifiers

NCT00450775

5299

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and patient acceptance of Dermatix Q for the prevention and treatment of scarring.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female or male patients at least 18 years of age
• Patients who are at serious risk of hypertrophic scarring (due to family history, race, recent surgery, etc)
• Able and willing to provide informed consent and likely to complete all study visits
• All Fitzpatrick skin types will be evaluated

Exclusion criteria

• Known contraindications to Dermatix or any of its components
• Age of scar is > 4 months
• Keloid scars (scars with increased fibroblastic activity that has exceeded the boundaries of the original scar)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

1

Other group

Treatment:

Drug: Dermatix Q