Hydraderm for Androgenic Alopecia

The Use of Hydradermabrasion in the Scalp to Improve Scalp Health and Improve Outcomes in Androgenetic Alopecia

Sponsors

Lead Sponsor: University of Minnesota

Source 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.

Overall Status Recruiting
Start Date 2022-03-14
Completion Date 2024-03-21
Primary Completion Date 2024-03-21
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Scalp Health- Erythema Assessed at Visit 8
Scalp Health- ASFS Assessed at Visit 8
Scalp Health- Folliculitis Assessed at Visit 8
Hair Changes Assessed at Visit 8
Enrollment 40
Condition
Intervention

Intervention Type: Device

Intervention Name: Venus Glow

Description: 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.

Arm Group Label: Treatment

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Ronda Farah Principal Investigator University of Minnesota
Overall Contact

Last Name: Irmina Wallander

Phone: 612-624-5721

Email: [email protected]

Location
Facility: Status: Contact: University of Minnesota Irmina Wallander 612-624-5721 [email protected]
Location Countries

United States

Verification Date

2022-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Treatment

Type: Experimental

Description: 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

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Every participant will receive the same treatment

Primary Purpose: Treatment

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News