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Hydraderm for Androgenic Alopecia

Primary Purpose

Androgenic Alopecia

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Venus Glow
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenic Alopecia focused on measuring alopecia, hair loss, pattern hair loss, hydradermabrasion, female pattern hair loss, male pattern hair loss, dermatology

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm 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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2022
Last Updated
June 21, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05426629
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
March 21, 2024 (Anticipated)
Study Completion Date
March 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenic Alopecia
Keywords
alopecia, hair loss, pattern hair loss, hydradermabrasion, female pattern hair loss, male pattern hair loss, dermatology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Every participant will receive the same treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Venus Glow
Intervention 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.
Primary Outcome Measure Information:
Title
Scalp Health- Erythema
Description
Primary endpoints will be changes in the Erythema score from baseline to Visit 8. Erythema score is a scale from 0 to 4.
Time Frame
Assessed at Visit 8
Title
Scalp Health- ASFS
Description
Primary endpoints will be changes in the Adherent Scalp Flaking Score (ASFS) from baseline to Visit 8. ASFS is a scale 0 to 10.
Time Frame
Assessed at Visit 8
Title
Scalp Health- Folliculitis
Description
Primary endpoints will be changes in the folliculitis score from baseline to Visit 8. Foliculitis score is a scale from 0 to 3.
Time Frame
Assessed at Visit 8
Title
Hair Changes
Description
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.
Time Frame
Assessed at Visit 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irmina Wallander
Phone
612-624-5721
Email
dermresearch@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronda Farah
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irmina Wallander
Phone
612-624-5721
Email
dermresearch@umn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hydraderm for Androgenic Alopecia

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