Wounds and InjuriesNCT03843996
Comparison of a Novel Wound Dressing Stratamed Versus Current Clinical Practice After Follicular Unit Extraction Hair Transplantation
A study testing Treatment - Stratamed in people with Wounds and Injuries, run by Stratpharma AG at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Treatment - Stratamed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2018to 8 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Able to provide informed consent
- Planning to undergo follicular unit extraction hair restoration
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
New Jersey Plastic Surgery, Montclair, NJ USA
Montclair, New Jersey, 07042
About this study
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.
- Conditions
- Wounds and Injuries
- Being tested
- Treatment - Stratamed
- Keywords
- Stratamed, wound healing, follicular unit extraction hair transplantation
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment - StratamedDevice
Also called wound healing
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment left | Experimental | A randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice. Receives: Device: Treatment - Stratamed |
| Treatment right | Experimental | A randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice. Receives: Device: Treatment - Stratamed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Measured: duration of the studybe evaluated and rated on days 1 (+1) and 7 (±1) post procedure for both the investigational and standard treatment products
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start3 Jan 2018
- Primary completion14 Dec 2018
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stratpharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843996
- Sponsor's protocol ID
- SPASM06
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2019
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: all IPD that underlie results for a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Novel Wound Dressing Stratamed Versus Current Clinical Practice After Follicular Unit Extraction Hair Transplantation
- ClinicalTrials.gov ID
- NCT03843996
- Acronym / sponsor ID
- SPASM06
- Conditions
- Wounds and Injuries
- Keywords
- Stratamed, wound healing, follicular unit extraction hair transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stratpharma AGIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Treatment left | Experimental | Device: Treatment - StratamedA randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice. |
| Treatment right | Experimental | Device: Treatment - StratamedA randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old
- Able to provide informed consent
- Planning to undergo follicular unit extraction hair restoration
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment - StratamedAlso: wound healingTo 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. | Device | Treatment left, Treatment right |
Primary outcome
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%)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Individual participant dataSharing planned: No. all IPD that underlie results for a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment - Stratamed in people with Wounds and Injuries, run by Stratpharma AG at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.