Alopecia Areata, Lichen Planopilaris of Scalp
Conditions
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.
Interventions
DEVICEVenus 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.
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Healthy-experimental |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 26.22 years STANDARD_DEVIATION 5.57 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
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
Time frame: Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy-experimental | Scalp Microbiome Composition | 10 genera | Standard Deviation 0.005 |
Secondary
Post-treatment 1 Right-sided Scalp Health
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)
Time frame: Assessed at day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy-experimental | Post-treatment 1 Right-sided Scalp Health | 1.18 score | Standard Deviation 0.99 |
Secondary
Post-treatment 2 Right-sided Scalp Health
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)
Time frame: Assessed at day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy-experimental | Post-treatment 2 Right-sided Scalp Health | 1.67 score | Standard Deviation 0.93 |
Secondary
Scalp Health
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)
Time frame: Assessed at day 1 (baseline).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy-experimental | Scalp Health | 1.21 score | Standard Deviation 1 |