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

NCT06357169 | Terminated Results FDA Device

• 1 other identifier: Venus Glow
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Lichen Planopilaris of Scalp; Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• 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

  Day 14

Secondary Outcomes (3)

• Scalp Health

  Assessed at day 1 (baseline).

• Post-treatment 1 Right-sided Scalp Health

  Assessed at day 7

• Post-treatment 2 Right-sided Scalp Health

  Assessed at day 14

Study Arms (1)

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.

Device: Venus Glow

Interventions

Venus Glow DEVICE

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.

Healthy-experimental

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Non-English speakers
• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The limitations of the trial are as follows: small sample size, short interim between treatment sessions, no scalp/hair disease group.

Results Point of Contact

• Title: Ronda Farah
• Organization: University of Minnesota

rfarah@umn.edu

(612) 625-8625

Study Officials

• Ronda Farah, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Maria Hordinsky, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: April 10, 2024
• Study Start: January 13, 2023
• Primary Completion: June 30, 2023
• Study Completion: January 13, 2024
• Last Updated: February 12, 2025
• Results First Posted: February 12, 2025

Record last verified: 2025-01

Locations

US (1)