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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06112782
Other study ID # HF-1801
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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