Androgenic Alopecia
Conditions
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.
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.
Interventions
DEVICEKeravive by Hydrafacial Treatments
Scalp hydradermabrasion
Sponsors
Skin Surgery Medical Group
ATS Clinical Research
Callender Center for Clinical Research
Rebecca Fitzgerald MD Inc.
Beauty Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hair Thinning and Temporal Hairline Recession | Day 0, Weeks 4, 8, and 20 | Investigator assessments of hair thinning and temporal line recession using Likert scales. |
| Scalp Health | Weeks 4, 8, and 20 | Subject-assessed improvement in scalp itchiness, dryness, and flakiness using Likert scales. |
| Hair Appearance | Day 0, Weeks 4, 8, and 20 | Investigator and subject assessments of hair appearance using Likert scales. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hair Health | Weeks 4, 8, and 20 | Subject-assessed improvement in hair health, fullness, evenness, pigment, hair growth and loss using Likert scales. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 20 weeks | Incidence and severity of investigator and subject reports of adverse events. |
Countries
United States
Outcome results
None listed