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

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.

Study Overview

• Status: Completed
• Conditions: Alopecia Areata; Lichen Planopilaris of Scalp
• Intervention / Treatment: Device: Venus Glow

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Healthy-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.

Device: Venus Glow; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Days 1, 7, and 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
scalp health	as assessed from HairMetrix photography and clinician ratings of photos, which depict the scalp and hair in 15x magnification	Days 1, 7, and 14

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Maria Hordinsky, MD, University of Minnesota; Principal Investigator: Ronda Farah, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): January 13, 2024

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Skin Diseases, Papulosquamous; Hypotrichosis; Hair Diseases; Lichenoid Eruptions; Alopecia; Alopecia Areata; Lichen Planus
• Other Study ID Numbers: Venus Glow

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes