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

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ClinicalTrials.gov Identifier: NCT03843996
Recruitment Status : Completed
First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Stratpharma AG

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.


Condition or disease Intervention/treatment Phase
Wounds and Injuries Device: Treatment - Stratamed Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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).
Masking: Triple (Care Provider, 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.
Primary Purpose: Treatment
Official Title: Comparison of a Novel Wound Dressing Stratamed Versus Current Clinical Practice After Follicular Unit Extraction Hair Transplantation
Actual Study Start Date : January 3, 2018
Actual Primary Completion Date : December 14, 2018
Actual Study Completion Date : January 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment left
A randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice.
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.
Other Name: wound healing

Experimental: Treatment right
A randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice.
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.
Other Name: wound healing




Primary Outcome Measures :
  1. Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1) [ Time Frame: 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%)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843996


Locations
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United States, New Jersey
New Jersey Plastic Surgery, Montclair, NJ USA
Montclair, New Jersey, United States, 07042
Sponsors and Collaborators
Stratpharma AG

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Responsible Party: Stratpharma AG
ClinicalTrials.gov Identifier: NCT03843996     History of Changes
Other Study ID Numbers: SPASM06
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: all IPD that underlie results for a publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Stratpharma AG:
Stratamed
wound healing
follicular unit extraction hair transplantation

Additional relevant MeSH terms:
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Wounds and Injuries