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

February 13, 2019 updated by: Stratpharma AG

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Montclair, New Jersey, United States, 07042
        • New Jersey Plastic Surgery, Montclair, NJ USA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • wound healing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%)
duration of the studybe evaluated and rated on days 1 (+1) and 7 (±1) post procedure for both the investigational and standard treatment products

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stratpharma AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2018

Primary Completion (Actual)

December 14, 2018

Study Completion (Actual)

January 8, 2019

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 13, 2019

First Posted (Actual)

February 18, 2019

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPASM06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

all IPD that underlie results for a publication

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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