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| Name | Class |
|---|---|
| Skin Surgery Medical Group | OTHER |
| ATS Clinical Research | OTHER |
| Callender Center for Clinical Research | OTHER |
| Rebecca Fitzgerald MD Inc. |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Keravive by Hydrafacial Treatments | Device | Scalp hydradermabrasion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hair Health | Subject-assessed improvement in hair health, fullness, evenness, pigment, hair growth and loss using Likert scales. | Weeks 4, 8, and 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Incidence and severity of investigator and subject reports of adverse events. | 20 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rebecca Fitzgerald MD Inc | Los Angeles | California | 90004 | United States | ||
| Laser & Skin Surgery Medical Group, Inc |
Plan for data to be published in peer-reviewed journal and presented at conferences.
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| UNKNOWN |
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| Sacramento |
| California |
| 95816 |
| United States |
| ATS Clinical Research | Santa Monica | California | 90404 | United States |
| Callender Center for Clinical Research | Glenn Dale | Maryland | 20769 | United States |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |