Wounds and Injuries
Conditions
Keywords
Stratamed, wound healing, follicular unit extraction hair transplantation
Brief 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.
Interventions
DEVICETreatment - 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
Stratpharma AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
This is an randomized, single-blind, split-scalp study, such that subjects will know what side of the scalp the investigational and standard treatment products are applied. The PI will evaluate efficacy and safety blinded.
Intervention model description
This Phase IV, post-marketing, single center study will be a single-blind, within subject split scalp efficacy comparison of Stratamed® and standard clinical practice, Bacitracin, post FUE. Twenty subjects desiring to undergo FUE for hair restoration will apply Stratamed® on one half of the donor area on the back of the scalp and Bacitracin on the other side at least twice a day for a week post procedure. The side of the scalp receiving each product will be randomized, and the evaluating physician will be blinded. Subjects will be evaluated, photographed, and will fill out subject reported questionnaires live at days 1 (+1) and 7 (±1) post procedure. Subjects will also fill out the subject reported questionnaires at home in between live study visits (days 2, 3, 4, 5, and 6).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Over 18 years old * Able to provide informed consent * Planning to undergo follicular unit extraction hair restoration
Exclusion criteria
* Significant medical or surgical conditions * Unable to give informed consent * Patient unable to apply topical device * Allergy or intolerance to ingredients or excipients of the formulation of studied products * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1) | duration of the studybe evaluated and rated on days 1 (+1) and 7 (±1) post procedure for both the investigational and standard treatment products | Stratamed will improve the healing response vs. current standard of care therapy. Healing Response (4 point ordinal scale) LEFT SIDE * Not healed at all (0%) * Mildly healed (33%) * Moderately healed (66%) * Completely healed (100%) RIGHT SIDE * Not healed at all (0%) * Mild healing (33%) * Moderately healed (66%) * Completely healed (100%) |
Countries
United States
Outcome results
None listed