Keravive by Hydrafacial for Scalp Health and Enhanced Hair Quality

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hydraderm for Androgenic Alopecia

NCT05426629

Androgenic Alopecia

WITHDRAWN PHASE4

Efficacy of the New Viviscal Professional Strength Oral Supplement in Females With Thinning Hair

NCT02302053

Hair Thinning

COMPLETED NA

Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia

NCT03852992

Male Pattern Hair Loss Androgenetic Alopecia Male Pattern Baldness

WITHDRAWN PHASE2

Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia

NCT04882969

Androgenetic Alopecia

WITHDRAWN NA

A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004512)

NCT01451125

Androgenetic Alopecia Male Pattern Baldness Female Pattern Baldness

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Androgenic Alopecia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Keravive by Hydrafacial Treatments

Intervention Type DEVICE

Scalp hydradermabrasion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Keravive by Hydrafacial Treatments

Scalp hydradermabrasion

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No