Clinical trial NCT05426629: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Androgenic Alopecia
Keywords: alopecia
hair loss
pattern hair loss
hydradermabrasion
female pattern hair loss
male pattern hair loss
dermatology
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Every participant will receive the same treatment
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Scalp Health- Erythema
timeFrame: Assessed at Visit 8
measure: Scalp Health- ASFS
timeFrame: Assessed at Visit 8
measure: Scalp Health- Folliculitis
timeFrame: Assessed at Visit 8
measure: Hair Changes
timeFrame: Assessed at Visit 8
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ronda Farah
role: PRINCIPAL_INVESTIGATOR
References: