Keravive by Hydrafacial for Scalp Health and Enhanced Hair Quality

NCT06112782 | Completed

• 1 other identifier: HF-1801
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 4

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.

Conditions

Androgenic Alopecia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Hair Health

  Weeks 4, 8, and 20

Other Outcomes (1)

• Adverse Events

  20 weeks

Study Arms (1)

Keravive by Hydrafacial Treatment

OTHER

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

Interventions

Keravive by Hydrafacial Treatments DEVICE

Scalp hydradermabrasion

Keravive by Hydrafacial Treatment

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beauty Health: lead
• Skin Surgery Medical Group: collaborator
• ATS Clinical Research: collaborator
• Callender Center for Clinical Research: collaborator
• Rebecca Fitzgerald MD Inc.: collaborator

Study Sites (4)

Rebecca Fitzgerald MD Inc

Los Angeles, California, 90004, United States

Location

Laser & Skin Surgery Medical Group, Inc

Sacramento, California, 95816, United States

Location

ATS Clinical Research

Santa Monica, California, 90404, United States

Location

Callender Center for Clinical Research

Glenn Dale, Maryland, 20769, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 1, 2023
• Study Start: July 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)