Hydraderm for Androgenic Alopecia | NCT05426629

NCT05426629

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases