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Completed

NCT Number: NCT06112782

Keravive by Hydrafacial for Scalp Health and Enhanced Hair Quality

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.

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Key information

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rebecca Fitzgerald MD Inc, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Keravive by Hydrafacial Treatments

Device

Scalp hydradermabrasion

Primary outcomes

  1. Hair Thinning and Temporal Hairline Recession

    Time frame: Day 0, Weeks 4, 8, and 20

    Investigator assessments of hair thinning and temporal line recession using Likert scales.

  2. Scalp Health

    Time frame: Weeks 4, 8, and 20

    Subject-assessed improvement in scalp itchiness, dryness, and flakiness using Likert scales.

  3. Hair Appearance

    Time frame: Day 0, Weeks 4, 8, and 20

    Investigator and subject assessments of hair appearance using Likert scales.

Secondary outcomes

  1. Hair Health

    Time frame: Weeks 4, 8, and 20

    Subject-assessed improvement in hair health, fullness, evenness, pigment, hair growth and loss using Likert scales.

Other outcomes

  1. Adverse Events

    Time frame: 20 weeks

    Incidence and severity of investigator and subject reports of adverse events.

Sponsors and collaborators

Lead sponsor

Beauty Health

Industry

Collaborators

  • ATS Clinical Research
  • Callender Center for Clinical Research
  • Rebecca Fitzgerald MD Inc.
  • Skin Surgery Medical Group

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2023
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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