Clinical trial NCT06112782: Keravive by Hydrafacial for Scalp Health and Enhanced Hair Quality
Official title: Efficacy and Safety of Keravive by Hydrafacial for Scalp Health and Enhanced Hair Quality in Patients With Androgenic Alopecia a Take-Home Hair Care Product and an In-Clinic Scalp Stimulating Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenic Alopecia
Lead sponsor: Beauty Health
Sponsor class: INDUSTRY
Collaborators: name: Skin Surgery Medical Group
name: ATS Clinical Research
name: Callender Center for Clinical Research
name: Rebecca Fitzgerald MD Inc.
First posted: 2023-11-01
Enrollment: 44
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to assess the efficacy and safety of Keravive by Hydrafacial treatments and Keravive Peptide Spray for scalp health and enhancing hair quality in patients with androgenic alopecia. This study is intended to be a single arm study. Suitable subjects who meet all inclusion criteria and consented will undergo 3 in-office Keravive by Hydrafacial treatments at Day 0 and Weeks 4 and 8 in combination with daily application on Keravive Peptide Spray at home.

Subjects will be assessed at Day 0, and Weeks 4, 8, and 20 by investigators using the Norwood Scale (males), Ludwig Classification (females), and a series of Likert scales for ranking improvement in scalp health and hair quality.

Detailed description: This study is intended to be a single arm study. Suitable subjects who meet all inclusion criteria and consented will undergo 3 in-office Keravive by Hydrafacial treatments at baseline and Weeks 4 and 8 in combination with daily application on Keravive Peptide Spray at home.

Subjects will be assessed at baseline, and Weeks 4, 8, and 20 by investigators using the Norwood Scale (males), Ludwig Classification (females), and a series of Likert scales for ranking improvement in scalp health and hair quality.

Efficacy will be assessed through a series of dynamic and static questionnaires. Investigators will complete static questionnaires at Day 0 and Weeks 4, 8 and 20 rating the subjects' hair appearance, thinning, and temporal line recession using Likert scales. Subjects will complete dynamic questionnaires at Weeks 4, 8 and 20 to compare their current state to their baseline condition for scalp symptoms (itchiness, dryness, and flakiness) and hair quality (overall health, fullness, evenness, pigment, hair growth, and hair loss) using Likert scales. Subjects will also rank their hair appearance at Day 0, Week 4, 8, and 20. Photography will be performed at each study visit. Safety assessments will include investigator- and subject-reported adverse events (AEs) during the study.

Eligibility criteria: Inclusion Criteria:

* Norwood Scale score of 2, 3 or 3 Vertex (males) and Ludwig Classification of Type I-1, I-2 or I-3 (females).

Exclusion Criteria:

* Non-study hair loss treatments (e.g., dutasteride, finasteride, minoxidil, nutraceuticals, PRP therapy, laser or LED scalp treatments, etc.)
* Salon treatments such as straightening, perms or coloring.

Primary outcomes:
measure: Hair Thinning and Temporal Hairline Recession
timeFrame: Day 0, Weeks 4, 8, and 20
measure: Scalp Health
timeFrame: Weeks 4, 8, and 20
measure: Hair Appearance
timeFrame: Day 0, Weeks 4, 8, and 20
Secondary outcomes:
measure: Hair Health
timeFrame: Weeks 4, 8, and 20
Other outcomes:
measure: Adverse Events
timeFrame: 20 weeks
Locations:
city: Los Angeles
country: United States
facility: Rebecca Fitzgerald MD Inc
state: California
city: Sacramento
country: United States
facility: Laser & Skin Surgery Medical Group, Inc
state: California
city: Santa Monica
country: United States
facility: ATS Clinical Research
state: California
city: Glenn Dale
country: United States
facility: Callender Center for Clinical Research
state: Maryland
Study officials:
References: