Comparison of a Novel Wound Dressing Stratamed Versus Current Clinical Practice After Follicular Unit Extraction Hair Transplantation

NCT03843996 | Completed FDA Device

• 1 other identifier: SPASM06
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds and Injuries

Keywords

Stratamed; wound healing; follicular unit extraction hair transplantation

Outcome Measures

Primary Outcomes (1)

• Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1)

  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%)

  duration of the studybe evaluated and rated on days 1 (+1) and 7 (±1) post procedure for both the investigational and standard treatment products

Study Arms (2)

Treatment left

EXPERIMENTAL

A randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice.

Device: Treatment - Stratamed

Treatment right

EXPERIMENTAL

A randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice.

Device: Treatment - Stratamed

Interventions

Treatment - Stratamed DEVICE

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.

Also known as: wound healing

Treatment left; Treatment right

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old
• Able to provide informed consent
• Planning to undergo follicular unit extraction hair restoration

You may not qualify if:

• 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

Sponsors & Collaborators

• Stratpharma AG: lead

Study Sites (1)

New Jersey Plastic Surgery, Montclair, NJ USA

Montclair, New Jersey, 07042, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 18, 2019
• Study Start: January 3, 2018
• Primary Completion: December 14, 2018
• Study Completion: January 8, 2019
• Last Updated: February 18, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)