Clinical trial NCT06357169: Mechanical Intervention on the Scalp Microbiome: Setting the Stage for the Future Management of Cicatricial Alopecias
Official title: Effect of Mechanical Intervention on the Scalp Microbiome: Setting the Stage for the Future Management of Cicatricial Alopecias
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lichen Planopilaris of Scalp
Alopecia Areata
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Scalp Microbiome Composition
timeFrame: Day 14
Secondary outcomes:
measure: Scalp Health
timeFrame: Assessed at day 1 (baseline).
measure: Post-treatment 1 Right-sided Scalp Health
timeFrame: Assessed at day 7
measure: Post-treatment 2 Right-sided Scalp Health
timeFrame: Assessed at day 14
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ronda Farah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Maria Hordinsky, MD
role: PRINCIPAL_INVESTIGATOR
References: