Androgenic AlopeciaPhase 4NCT05426629
Hydraderm for Androgenic Alopecia
A Phase 4 study testing Venus Glow in people with Androgenic Alopecia, run by University of Minnesota at 1 site in United States.
Trial summary
The study will be focused on evaluating the use of hydradermabrasion on the scalp. The study aims to assess the effect of this treatment on scalp health and hair growth. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- Venus Glow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2022to 21 Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who can give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPAA Authorization
- Participants who have androgenetic alopecia
- Healthy men and women, ages 18 - 65 years of age
- Participants who understand the study and can follow study instructions and are willing to attend the required study visits
- Participants who agree to be photographed for research purposes and their identity may not be concealed in these photographs.
- Participants who agree to continue their same treatment they are on at the baseline visit for androgenetic alopecia, for the entire duration of the study without plans to stop, change or add additional treatments.
- Participants who agree to use the same shampoo for the duration of the study
Who cannot join
- Participants who have not had a change to hair loss treatment for 4 months prior to study enrollment
- Participants who have an active or known skin inflammation or infection within the treatment area.
- Participants who have an active or known acute skin allergies
- Participants who have any other scalp conditions including eczema, psoriasis, infection, or scars within the treatment area
- Participants of child-bearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy, or bilateral oophorectomy.
- Participants who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy.
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- Immunosuppression
- Participants who are HIV+ / Hepatitis B + / Hepatitis C+
- Participants who have been diagnosed or have a known history of any hematopathology disorders
- Participants who have been diagnosed or have a known history of haemostasis disorders
- Participants who have been diagnosed or have a known history of an autoimmune diseases
- Participants who are undergoing chemotherapy
- Participants with a history of any skin cancer on the scalp
- Participants who have had skin biopsy or procedure on scalp in last month
- Participants who have an implantable devices such as a deep brain stimulator in or other implantable device on or near treatment area
- Non-English speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: The Use of Hydradermabrasion in the Scalp to Improve Scalp Health and Improve Outcomes in Androgenetic Alopecia
The study will be focused on evaluating the use of hydradermabrasion on the scalp. The study aims to assess the effect of this treatment on scalp health and hair growth.
- Conditions
- Androgenic Alopecia
- Being tested
- Venus Glow
- Keywords
- alopecia, hair loss, pattern hair loss, hydradermabrasion, female pattern hair loss, male pattern hair loss, dermatology
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venus GlowDevice
The Venus Glow hydradermabrasion device is a class 1 device trimodality dermal system consisting of vacuum, 360 degrees rotating tip and two jet streams of saline.
Adjustable vacuum deep cleanses the pores by pulling up daily dirt and debris, dry and dead skin cells, and excess sebum from the stratum corneum. It helps increase the microcirculation.
The 360-degree rotation helps in spreading the saline evenly, which is expelled from two ultra-fine jet streams. This micro massaging helps in faster release of nutrients from the skin. The jet stream is smaller than the average pore size measuring 50- 70 microns each, enabling the jet stream to deep clean each pore.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 4 sessions of treatment at 1-week interval for first 4 weeks 3 sessions of treatment each 4 weeks apart, at week 8, week 12 and week 16
1 Follow-up visit: Follow up 4 weeks after the last treatment at week 20 Receives: Device: Venus Glow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scalp Health- Erythema
Primary endpoints will be changes in the Erythema score from baseline to Visit 8. Erythema score is a scale from 0 to 4.
Measured: Assessed at Visit 8
Scalp Health- ASFS
Primary endpoints will be changes in the Adherent Scalp Flaking Score (ASFS) from baseline to Visit 8. ASFS is a scale 0 to 10.
Measured: Assessed at Visit 8
Scalp Health- Folliculitis
Primary endpoints will be changes in the folliculitis score from baseline to Visit 8. Foliculitis score is a scale from 0 to 3.
Measured: Assessed at Visit 8
Hair Changes
HairMetrix scale evaluates degree of improvement hair density, total hair count per sq cm and patient sensory assessment of scalp and hair from baseline to after each treatment and the follow up visit. The global assessment scales are a scale from 0 to 3.
Measured: Assessed at Visit 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start14 Mar 2022
- Primary completion21 Apr 2025 (estimated)
- Study completion21 Apr 2025 (estimated)
Why it stopped: IRB closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Every participant will receive the same treatment
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronda Farah, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426629
- Sponsor's protocol ID
- DERM-2021-30436
- Status last verified
- Jan 2025
- First submitted
- 29 Mar 2022
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Hydradermabrasion in the Scalp to Improve Scalp Health and Improve Outcomes in Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT05426629
- Acronym / sponsor ID
- DERM-2021-30436
- Conditions
- Androgenic Alopecia
- Keywords
- alopecia, hair loss, pattern hair loss, hydradermabrasion, female pattern hair loss, male pattern hair loss, dermatology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB closed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 21 Apr 2025 (estimated)
- Study completion
- 21 Apr 2025 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be focused on evaluating the use of hydradermabrasion on the scalp. The study aims to assess the effect of this treatment on scalp health and hair growth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Every participant will receive the same treatment
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Venus Glow4 sessions of treatment at 1-week interval for first 4 weeks 3 sessions of treatment each 4 weeks apart, at week 8, week 12 and week 16 1 Follow-up visit: Follow up 4 weeks after the last treatment at week 20 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants who can give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPAA Authorization
- Participants who have androgenetic alopecia
- Healthy men and women, ages 18 - 65 years of age
- Participants who understand the study and can follow study instructions and are willing to attend the required study visits
- Participants who agree to be photographed for research purposes and their identity may not be concealed in these photographs.
Key exclusion criteria (16 listed)
- Participants who have not had a change to hair loss treatment for 4 months prior to study enrollment
- Participants who have an active or known skin inflammation or infection within the treatment area.
- Participants who have an active or known acute skin allergies
- Participants who have any other scalp conditions including eczema, psoriasis, infection, or scars within the treatment area
- Participants of child-bearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy, or bilateral oophorectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venus GlowThe Venus Glow hydradermabrasion device is a class 1 device trimodality dermal system consisting of vacuum, 360 degrees rotating tip and two jet streams of saline. Adjustable vacuum deep cleanses the pores by pulling up daily dirt and debris, dry and dead skin cells, and excess sebum from the stratum corneum. It helps increase the microcirculation. The 360-degree rotation helps in spreading the saline evenly, which is expelled from two ultra-fine jet streams. This micro massaging helps in faster release of nutrients from the skin. The jet stream is smaller than the average pore size measuring 50- 70 microns each, enabling the jet stream to deep clean each pore. | Device | Treatment |
Primary outcome
Scalp Health- Erythema
Time frame: Assessed at Visit 8
Primary endpoints will be changes in the Erythema score from baseline to Visit 8. Erythema score is a scale from 0 to 4.
Scalp Health- ASFS
Time frame: Assessed at Visit 8
Primary endpoints will be changes in the Adherent Scalp Flaking Score (ASFS) from baseline to Visit 8. ASFS is a scale 0 to 10.
Scalp Health- Folliculitis
Time frame: Assessed at Visit 8
Primary endpoints will be changes in the folliculitis score from baseline to Visit 8. Foliculitis score is a scale from 0 to 3.
Hair Changes
Time frame: Assessed at Visit 8
HairMetrix scale evaluates degree of improvement hair density, total hair count per sq cm and patient sensory assessment of scalp and hair from baseline to after each treatment and the follow up visit. The global assessment scales are a scale from 0 to 3.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronda Farah principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Venus Glow in people with Androgenic Alopecia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scalp Health- Erythema (time frame: Assessed at Visit 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.