Keravive by Hydrafacial for Scalp Health and Enhanced Hair Quality

Androgenic Alopecia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06112782
• Other study ID #: HF-1801
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: October 2023
• Source: Beauty Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenic Alopecia

Intervention

Device:
• Keravive by Hydrafacial Treatments
Scalp hydradermabrasion

Locations

Country	Name	City	State
United States	Callender Center for Clinical Research	Glenn Dale	Maryland
United States	Rebecca Fitzgerald MD Inc	Los Angeles	California
United States	Laser & Skin Surgery Medical Group, Inc	Sacramento	California
United States	ATS Clinical Research	Santa Monica	California

Sponsors (5)

Lead Sponsor	Collaborator
Beauty Health	ATS Clinical Research, Callender Center for Clinical Research, Rebecca Fitzgerald MD Inc., Skin Surgery Medical Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Incidence and severity of investigator and subject reports of adverse events.	20 weeks
Primary	Hair Thinning and Temporal Hairline Recession	Investigator assessments of hair thinning and temporal line recession using Likert scales.	Day 0, Weeks 4, 8, and 20
Primary	Scalp Health	Subject-assessed improvement in scalp itchiness, dryness, and flakiness using Likert scales.	Weeks 4, 8, and 20
Primary	Hair Appearance	Investigator and subject assessments of hair appearance using Likert scales.	Day 0, Weeks 4, 8, and 20
Secondary	Hair Health	Subject-assessed improvement in hair health, fullness, evenness, pigment, hair growth and loss using Likert scales.	Weeks 4, 8, and 20