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

Stratpharma

Status: Completed

Conditions: Wounds and Injuries

Treatments: Device: Treatment - Stratamed

Study type: Interventional

Funder types: Industry

Identifiers

NCT03843996

SPASM06

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Treatment left

Experimental group

Description:

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

Treatment:

Device: Treatment - Stratamed

Treatment right

Experimental group

Description:

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

Treatment:

Device: Treatment - Stratamed

Sponsor of this trial

Lead Sponsor

Stratpharma