Hydraderm for Androgenic Alopecia

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Brief Title

Hydraderm for Androgenic Alopecia

Official Title

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

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.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Scalp Health- Erythema


Condition

Androgenic Alopecia

Intervention

Venus Glow

Study Arms / Comparison Groups

 Treatment
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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

40

Start Date

March 14, 2022

Completion Date

March 21, 2024

Primary Completion Date

March 21, 2024

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

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Ronda Farah, 612-624-5721, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05426629

Organization ID

DERM-2021-30436


Responsible Party

Sponsor

Study Sponsor

University of Minnesota


Study Sponsor

Ronda Farah, Principal Investigator, University of Minnesota


Verification Date

June 2022