Comparison of a Novel Wound Dressing Stratamed Versus Current Clinical Practice After Follicular Unit Extraction Hair Transplantation
Primary Purpose
Wounds and Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment - Stratamed
Sponsored by
About this trial
This is an interventional treatment trial for Wounds and Injuries focused on measuring Stratamed, wound healing, follicular unit extraction hair transplantation
Eligibility 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
Sites / Locations
- New Jersey Plastic Surgery, Montclair, NJ USA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment left
Treatment right
Arm Description
A randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice.
A randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice.
Outcomes
Primary Outcome Measures
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%)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03843996
Brief Title
Comparison of a Novel Wound Dressing Stratamed Versus Current Clinical Practice After Follicular Unit Extraction Hair Transplantation
Official Title
Comparison of a Novel Wound Dressing Stratamed Versus Current Clinical Practice After Follicular Unit Extraction Hair Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
December 14, 2018 (Actual)
Study Completion Date
January 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stratpharma AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries
Keywords
Stratamed, wound healing, follicular unit extraction hair transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Care ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment left
Arm Type
Experimental
Arm Description
A randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice.
Arm Title
Treatment right
Arm Type
Experimental
Arm Description
A randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice.
Intervention Type
Device
Intervention Name(s)
Treatment - Stratamed
Other Intervention Name(s)
wound healing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1)
Description
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%)
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
New Jersey Plastic Surgery, Montclair, NJ USA
City
Montclair
State/Province
New Jersey
ZIP/Postal Code
07042
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
all IPD that underlie results for a publication
Learn more about this trial
Comparison of a Novel Wound Dressing Stratamed Versus Current Clinical Practice After Follicular Unit Extraction Hair Transplantation
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