Hydraderm for Androgenic Alopecia

NCT05426629 | Withdrawn Phase 4 DMC FDA Device

• 1 other identifier: DERM-2021-30436
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

alopecia; hair loss; pattern hair loss; hydradermabrasion; female pattern hair loss; male pattern hair loss; dermatology

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Assessed at Visit 8

Study Arms (1)

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

Device: Venus Glow

Interventions

Venus Glow 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.

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronda Farah

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Every participant will receive the same treatment

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: June 22, 2022
• Study Start: March 14, 2022
• Primary Completion: April 21, 2025
• Study Completion: April 21, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)