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

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03843996
• Other study ID #: SPASM06
• Status: Completed
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: January 8, 2019

Study information

• Verified date: February 2019
• Source: Stratpharma AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 8, 2019
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	New Jersey Plastic Surgery, Montclair, NJ USA	Montclair	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Stratpharma AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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