Laser Treatment for the Improvement of Scars and Scleroderma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Scars
- Scleroderma
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The investigators will be performing a randomized-controlled split-lesion study, where each subject will act as his or her own control. One half or side of the lesion will be randomized to receive laser treatment only.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study is designed to evaluate the efficacy of laser treatment for the improvement of the clinical appearance of disorders of collagen metabolism, including hypertrophic scars and scleroderma. The investigators will be performing a randomized-controlled split-lesion study, where each patient wil...
This study is designed to evaluate the efficacy of laser treatment for the improvement of the clinical appearance of disorders of collagen metabolism, including hypertrophic scars and scleroderma. The investigators will be performing a randomized-controlled split-lesion study, where each patient will act as his or her own control. One half or side of the lesion will be randomized to receive laser treatment only. The investigators plan to have 20 patients (10 patients with hypertrophic scars and 10 patients with scleroderma) complete the study. Subjects must be equal to greater than 18 years old, but may be any gender or Fitzpatrick skin type. They must have one of the following: at least one extragenital hypertrophic scar, or at least one extragenital area of scleroderma . Subjects must not have received any prescription or in-clinic medications or treatments, such as intralesional corticosteroids or excision, on the eligible scars/scleroderma in the previous 3 months. Those on anti-inflammatory or immunosuppressive medications will also be excluded.
Tracking Information
- NCT #
- NCT04567537
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Dieter Manstein, MD, PhD Massachusetts General Hospital Principal Investigator: Neera Nathan, MD, MSHS Massachusetts General Hospital