Keravive by Hydrafacial for Scalp Health and Enhanced Hair Quality

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

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.

Study Overview

• Status: Completed
• Conditions: Androgenic Alopecia
• Intervention / Treatment: Device: Keravive by Hydrafacial Treatments

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90004
      • Rebecca Fitzgerald MD Inc
    • Sacramento, California, United States, 95816
      • Laser & Skin Surgery Medical Group, Inc
    • Santa Monica, California, United States, 90404
      • ATS Clinical Research
  • Maryland
    • Glenn Dale, Maryland, United States, 20769
      • Callender Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Keravive by Hydrafacial Treatment; Subjects will receive 3 in-office scalp Keravive by Hydrafacial treatments every 4 weeks in combination with daily application of Keravive Peptide Spray.	Device: Keravive by Hydrafacial Treatments; Scalp hydradermabrasion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Scalp Health	Subject-assessed improvement in scalp itchiness, dryness, and flakiness using Likert scales.	Weeks 4, 8, and 20
Hair Appearance	Investigator and subject assessments of hair appearance using Likert scales.	Day 0, Weeks 4, 8, and 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair Health	Subject-assessed improvement in hair health, fullness, evenness, pigment, hair growth and loss using Likert scales.	Weeks 4, 8, and 20

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Incidence and severity of investigator and subject reports of adverse events.	20 weeks

Collaborators and Investigators

• Sponsor: Beauty Health
• Collaborators: Callender Center for Clinical Research; ATS Clinical Research; Skin Surgery Medical Group; Rebecca Fitzgerald MD Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: HF-1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Plan for data to be published in peer-reviewed journal and presented at conferences.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No