Comparison of a Novel Wound Dressing Stratamed Versus Current Clinical Practice After Follicular Unit Extraction Hair Transplantation
NCT03843996 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2019-02-18
Summary
Follicular donor sites on the scalp for hair transplantation will be treated with studied products post harvest.
A randomized side of the scalp will be treated with Stratamed, the other side with standard clinical practice.
Subjects will be assessed live immediately post treatment and in 2 sessions during the healing phase post harvest. Subjects will also complete subject reported outcome questionnaires at home between study visits.
Conditions
- Wounds and Injuries
Interventions
- DEVICE
-
Treatment - Stratamed
To determine if Stratamed is more effective than standard of care therapy in limiting severity and duration of signs and symptoms of acute inflammation post follicular harvesting procedure.
Sponsors & Collaborators
-
Stratpharma AG
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-01-03
- Primary Completion
- 2018-12-14
- Completion
- 2019-01-08
- FDA Device
- Yes
Countries
- United States
Study Locations
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