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WithdrawnNCT05426629Updated Jan 27, 2025

Hydraderm for Androgenic Alopecia

A Phase 4 interventional study of Venus Glow in Androgenic Alopecia, sponsored by University of Minnesota. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-27.

Sponsored by University of Minnesota · Phase 4, Interventional, and Treatment

Why this study was withdrawn
IRB closed
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Androgenic Alopecia

Keywords

  • alopecia
  • hair loss
  • pattern hair loss
  • hydradermabrasion
  • female pattern hair loss
  • male pattern hair loss
  • dermatology
03

In context

Alopecia

609 studies on the registry are indexed under Alopecia; 131 are open to participants now.

Browse Alopecia studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Treatment

    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

    Device: Venus Glow

Interventions

  • DeviceVenus Glow

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Assessed at Visit 8

  2. 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.

    Time frame: Assessed at Visit 8

  3. 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.

    Time frame: Assessed at Visit 8

  4. 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.

    Time frame: Assessed at Visit 8

07

Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05426629
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Jun 22, 2022
Start date
Mar 14, 2022
Primary completion
Apr 21, 2025 (estimated)
Completion
Apr 21, 2025 (estimated)
Last update
Jan 27, 2025

Study contacts

Ronda Farah
principal investigator · University of Minnesota

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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