Hydraderm for Androgenic Alopecia

Phase 4

Withdrawn

• Conditions: Androgenic Alopecia
• Interventions: Device: Venus Glow

• Registration Number: NCT05426629
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-14
• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Primary Completion: 2025-04-21
• Study Completion: 2025-04-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 40

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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Venus Glow	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

Primary Outcome Measures

Name	Time	Method
Scalp Health- ASFS	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- Erythema	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- Folliculitis	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	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States