Lichen Planopilaris of ScalpNCT06357169
Mechanical Intervention on the Scalp Microbiome: Setting the Stage for the Future Management of Cicatricial Alopecias
A study testing Venus Glow in people with Lichen Planopilaris of Scalp and Alopecia Areata, run by University of Minnesota at 1 site in United States.
Trial summary
The objective of this study is to assess the effect of standardized scalp care, specifically mechanical cleansing with the Venus Glow™ Device and water, on the scalp microbiome. This study also seeks to characterize the microbiome of the normal, healthy scalp, thereby providing a baseline for which the scalp affected… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Lichen Planopilaris of Scalp, Alopecia Areata
- What is being tested?
- Venus Glow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2023to 13 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All individuals between 18-35 years of age
- Ability to understand study procedures and to comply with them
Who cannot join
- Non-English speakers
- Exclusion related to pregnancy, lactation, or has plans to become pregnant over the course of the study, Based on self-report from the participant
- Current scalp or hair disease diagnosis
- Using oral or topical antimicrobial medication 4 weeks prior to their baseline visit or in the duration of the study
- Current clinical condition that, in the opinion of the site investigator, would interfere with adherence to study requirements
- Inability or unwillingness of individual to give written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Effect of Mechanical Intervention on the Scalp Microbiome: Setting the Stage for the Future Management of Cicatricial Alopecias
The objective of this study is to assess the effect of standardized scalp care, specifically mechanical cleansing with the Venus Glow™ Device and water, on the scalp microbiome. This study also seeks to characterize the microbiome of the normal, healthy scalp, thereby providing a baseline for which the scalp affected by hair and scalp disease can be compared.
Read the detailed description
The study will assess the effect of mechanical cleansing with the Venus GlowTM Device and water on the scalp microbiome over the course of five in-person visits, each lasting approximately 30-45 minutes. We will test if cleansing the scalp with a mechanical cleansing device changes the composition of the scalp microbiome and improves scalp health. The scalp was swabbed for DNA extraction. Subjects will avoid shampooing, chemical, or heat treatments, but will be able to wet their hair during the study. We also seek to characterize the microbiome of the normal, healthy scalp to provide a baseline for which the scalp affected by hair and scalp disease (e.g., cicatricial alopecia) can be compared.
The first visit will consist of questionnaires about demographics, participants' current hair and scalp practices, skin type, and hair type. The study staff will also swab the mid-frontal regions of the scalp on the right and left sides and take HairMetrix photography. The participant will subsequently undergo Venus GlowTM treatment #1 on the right side of the scalp only. After the treatment, the study staff will re-swab the right side of the scalp. HairMetrix photography in the two swab sites will be taken after each subsequent treatment discussed below.
Visit 2, three days after visit 1, will assess adverse effects, if applicable, from the first treatment. The right side of the scalp will be treated with the Venus GlowTM device again.
Visit 3, three days after visit 2, will also assess adverse effects, if applicable from the second treatment. The study staff will swab the mid-frontal regions of the scalp on the right and left sides. The participant will subsequently undergo Venus GlowTM treatment #3 on the right side of the scalp only. After the treatment, the study staff will re-swab the right side of the scalp.
Visit 4, three days after visit 3, will begin with the adverse effects assessment/check-in. Then, the participant will undergo Venus GlowTM treatment #4 on the right side of the scalp.
Visit 5, approximately two weeks after Visit 1, is the follow-up visit. No treatment will be performed at this last visit. An adverse effects assessment will take place, and the study staff will swab both the right and left mid-frontal regions of the scalp.
- Conditions
- Lichen Planopilaris of Scalp, Alopecia Areata
- Being tested
- Venus Glow
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venus GlowDevice
two treatments over a one week period. At the first visit they will complete an initial questionnaire regarding current scalp care practices, skin type, and hair type. An initial baseline scalp swab and HairMetrix photography in the two swab sites will be taken at the beginning of this visit. Treatment with the Venus Glow™ device will also occur. To treat, the scalp will be divided into four quadrants. Swab samples will be collected at the first baseline and concurrent treatment session, second treatment session and 3-6 days after the last treatment when participants have returned to their usual cleansing routine.
| Study group | Role | What they receive |
|---|---|---|
| Healthy-experimental | Experimental | Healthy participants who have not been diagnosed with scalp or hair disease will be followed over a period of 2 weeks to assess their scalp microbiome and see how well the investigational device works on decreasing the microbe burden of the scalp. Receives: Device: Venus Glow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scalp Microbiome Composition
as assessed by relative abundance of genera from scalp swab DNA extraction of the right and left mid-frontal scalp. Kruskal-Wallis will be used to assess variation in microbiome composition between treatment groups
Measured: Day 14
Secondary outcomes (3)
Scalp Health
Blinded scalp health ratings of standardized scalp photos of 15x magnification were completed by two board-certified dermatologists using the Adherent Scalp Flaking Score (0=no scales, 1=thin scales, 2=diffused thin scales, 3=thick heaped-up scales but not forming plaques, 4=diffused thick heaped-up scales but not forming plaques, 5=very thick heaped-up scales forming plaques)
Measured: Assessed at day 1 (baseline).
Post-treatment 1 Right-sided Scalp Health
Blinded scalp health ratings of standardized scalp photos of 15x magnification were completed by two board-certified dermatologists using the Adherent Scalp Flaking Score (0=no scales, 1=thin scales, 2=diffused thin scales, 3=thick heaped-up scales but not forming plaques, 4=diffused thick heaped-up scales but not forming plaques, 5=very thick heaped-up scales forming plaques)
Measured: Assessed at day 7
Post-treatment 2 Right-sided Scalp Health
Blinded scalp health ratings of standardized scalp photos of 15x magnification were completed by two board-certified dermatologists using the Adherent Scalp Flaking Score (0=no scales, 1=thin scales, 2=diffused thin scales, 3=thick heaped-up scales but not forming plaques, 4=diffused thick heaped-up scales but not forming plaques, 5=very thick heaped-up scales forming plaques)
Measured: Assessed at day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start13 Jan 2023
- Primary completion30 Jun 2023
- Study completion13 Jan 2024
Why it stopped: There was only one participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lichen Planopilaris of ScalpStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronda Farah, MD, Principal investigator, University of MinnesotaMaria Hordinsky, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357169
- Sponsor's protocol ID
- Venus Glow
- Status last verified
- Jan 2025
- First submitted
- 27 Feb 2023
- Last updated
- 12 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mechanical Intervention on the Scalp Microbiome: Setting the Stage for the Future Management of Cicatricial Alopecias
- ClinicalTrials.gov ID
- NCT06357169
- Acronym / sponsor ID
- Venus Glow
- Conditions
- Lichen Planopilaris of Scalp, Alopecia Areata
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There was only one participant
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 13 Jan 2024 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Posted 12 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the effect of standardized scalp care, specifically mechanical cleansing with the Venus Glow™ Device and water, on the scalp microbiome. This study also seeks to characterize the microbiome of the normal, healthy scalp, thereby providing a baseline for which the scalp affected by hair and scalp disease can be compared.
Detailed description
The study will assess the effect of mechanical cleansing with the Venus GlowTM Device and water on the scalp microbiome over the course of five in-person visits, each lasting approximately 30-45 minutes. We will test if cleansing the scalp with a mechanical cleansing device changes the composition of the scalp microbiome and improves scalp health. The scalp was swabbed for DNA extraction. Subjects will avoid shampooing, chemical, or heat treatments, but will be able to wet their hair during the study. We also seek to characterize the microbiome of the normal, healthy scalp to provide a baseline for which the scalp affected by hair and scalp disease (e.g., cicatricial alopecia) can be compared.
The first visit will consist of questionnaires about demographics, participants' current hair and scalp practices, skin type, and hair type. The study staff will also swab the mid-frontal regions of the scalp on the right and left sides and take HairMetrix photography. The participant will subsequently undergo Venus GlowTM treatment #1 on the right side of the scalp only. After the treatment, the study staff will re-swab the right side of the scalp. HairMetrix photography in the two swab sites will be taken after each subsequent treatment discussed below.
Visit 2, three days after visit 1, will assess adverse effects, if applicable, from the first treatment. The right side of the scalp will be treated with the Venus GlowTM device again.
Visit 3, three days after visit 2, will also assess adverse effects, if applicable from the second treatment. The study staff will swab the mid-frontal regions of the scalp on the right and left sides. The participant will subsequently undergo Venus GlowTM treatment #3 on the right side of the scalp only. After the treatment, the study staff will re-swab the right side of the scalp.
Visit 4, three days after visit 3, will begin with the adverse effects assessment/check-in. Then, the participant will undergo Venus GlowTM treatment #4 on the right side of the scalp.
Visit 5, approximately two weeks after Visit 1, is the follow-up visit. No treatment will be performed at this last visit. An adverse effects assessment will take place, and the study staff will swab both the right and left mid-frontal regions of the scalp.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy-experimental | Experimental | Device: Venus GlowHealthy participants who have not been diagnosed with scalp or hair disease will be followed over a period of 2 weeks to assess their scalp microbiome and see how well the investigational device works on decreasing the microbe burden of the scalp. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All individuals between 18-35 years of age
- Ability to understand study procedures and to comply with them
Key exclusion criteria (6 listed)
- Non-English speakers
- Exclusion related to pregnancy, lactation, or has plans to become pregnant over the course of the study, Based on self-report from the participant
- Current scalp or hair disease diagnosis
- Using oral or topical antimicrobial medication 4 weeks prior to their baseline visit or in the duration of the study
- Current clinical condition that, in the opinion of the site investigator, would interfere with adherence to study requirements
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 |
|---|---|---|
| Venus Glowtwo treatments over a one week period. At the first visit they will complete an initial questionnaire regarding current scalp care practices, skin type, and hair type. An initial baseline scalp swab and HairMetrix photography in the two swab sites will be taken at the beginning of this visit. Treatment with the Venus Glow™ device will also occur. To treat, the scalp will be divided into four quadrants. Swab samples will be collected at the first baseline and concurrent treatment session, second treatment session and 3-6 days after the last treatment when participants have returned to their usual cleansing routine. | Device | Healthy-experimental |
Primary outcome
Scalp Microbiome Composition
Time frame: Day 14
as assessed by relative abundance of genera from scalp swab DNA extraction of the right and left mid-frontal scalp. Kruskal-Wallis will be used to assess variation in microbiome composition between treatment groups
3 secondary outcomes
Scalp Health
Time frame: Assessed at day 1 (baseline).
Post-treatment 1 Right-sided Scalp Health
Time frame: Assessed at day 7
Post-treatment 2 Right-sided Scalp Health
Time frame: Assessed at day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Ronda Farah, MD principal investigator
University of Minnesota
Maria Hordinsky, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venus Glow in people with Lichen Planopilaris of Scalp and Alopecia Areata, run by University of Minnesota 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 12 Feb 2025. 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?
Yes. Results are posted in the registry (first posted 12 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Scalp Microbiome Composition (time frame: Day 14). 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 12 Feb 2025.