Hydraderm for Androgenic Alopecia

NCT ID: NCT05426629

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-14
• Study Completion Date: 2025-04-21

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.

Conditions

Androgenic Alopecia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Venus Glow

Intervention Type: DEVICE

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.

Interventions

Venus 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronda Farah

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

DERM-2021-30436

Identifier Type: -

Identifier Source: org_study_id