NCT06357169|TerminatedResultsFDA Device
Study Stopped
There was only one participant
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There was only one participant
Effect of Mechanical Intervention on the Scalp Microbiome: Setting the Stage for the Future Management of Cicatricial Alopecias
Sponsor study identifier
interventional
23
1 country
1
Study Start
January 13, 2023
Actual (reported)Primary Completion
June 30, 2023
Actual (reported)Study Completion
January 13, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 13, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 13, 2023
Actual (reported)February 27, 2023
Actual (reported)June 30, 2023
Actual (reported)January 13, 2024
Actual (reported)April 10, 2024
Actual (reported)February 12, 2025
Actual (reported)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
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Minnesota
Minneapolis, Minnesota, 55455, United States
The limitations of the trial are as follows: small sample size, short interim between treatment sessions, no scalp/hair disease group.
Ronda Farah, MD
University of Minnesota
Maria Hordinsky, MD
University of Minnesota
23 participants (actual enrollment reported by the registry).
First Submitted
February 27, 2023
First Posted
April 10, 2024
Study Start
January 13, 2023
Actual (reported)Methotrexate Versus Triamcinilone Acetonide in Treatment of Recalcitrant Alopecia Areata
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2023
Actual (reported)Study Completion
January 13, 2024
Actual (reported)Last Updated
February 12, 2025
Results First Posted
February 12, 2025
Record last verified: 2025-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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