Mechanical Intervention on the Scalp Microbiome: Setting the Stage for the Future Management of Cicatricial Alopecias

Not Applicable

Terminated

Conditions: Lichen Planopilaris of Scalp
Alopecia Areata

Interventions: Device: Venus Glow

Registration Number: NCT06357169

Lead Sponsor: University of Minnesota

Brief 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 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 23

Inclusion Criteria

All individuals between 18-35 years of age
Ability to understand study procedures and to comply with them

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy-experimental	Venus Glow	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.

Primary Outcome Measures

Name	Time	Method
Scalp Microbiome Composition	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

Secondary Outcome Measures

Name	Time	Method
Scalp Health	Assessed at day 1 (baseline).	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)
Post-treatment 1 Right-sided Scalp Health	Assessed at day 7	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)
Post-treatment 2 Right-sided Scalp Health	Assessed at day 14	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)