Keravive by Hydrafacial Treatments
DeviceScalp hydradermabrasion
NCT Number: NCT06112782
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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Notify Me30 year–55 year
All sexes
Interventional
Not applicable
Rebecca Fitzgerald MD Inc, Los Angeles, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Scalp hydradermabrasion
Time frame: Day 0, Weeks 4, 8, and 20
Investigator assessments of hair thinning and temporal line recession using Likert scales.
Time frame: Weeks 4, 8, and 20
Subject-assessed improvement in scalp itchiness, dryness, and flakiness using Likert scales.
Time frame: Day 0, Weeks 4, 8, and 20
Investigator and subject assessments of hair appearance using Likert scales.
Time frame: Weeks 4, 8, and 20
Subject-assessed improvement in hair health, fullness, evenness, pigment, hair growth and loss using Likert scales.
Time frame: 20 weeks
Incidence and severity of investigator and subject reports of adverse events.
Beauty Health
Industry
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
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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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