Scalp Serum Paired With HydraFacial HydraScalp Keravive™ Treatment in Patients With Self-Perceived Hair Thinning
A Single-Center, Open-Label Case Study to Assess Scalp Serum Paired With HydraFacial HydraScalp Keravive™ Treatment in Patients With Self-Perceived Hair Thinning
Briefly, this study will evaluate a procedure-pairing regimen consisting of three (3) HydraScalp Keravive™ treatments, administered approximately one (1) month apart, paired with once-daily at-home use of a scalp serum (IP). The IP will also be applied at the study site immediately after each HydraScalp Keravive™ treatment to replace the HydraScalp™ Peptide Complex Spray. Prospective Candidates will be consented and screened at Visit 1/Baseline (V1/BL). After being accepted into the study, subjects will be instructed to stop the use of all products on their scalp per Inclusion Criterion for the duration of the study.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
At V1/BL, Subjects will report to a Dermatologist, who will classify their hair loss using the Ludwig Scale (females) or Norwood Scale (males) and make BL evaluations of Redness, Dryness, Flaking/Dandruff, and Bumps. Subjects will then rate the Itching, Burning, and Stinging of their scalp and complete a Quality of Life (QOL) questionnaire. A Technician will take standardized clinical photographs and Canfield HairMetrix® images of the scalp before treatment. Subjects will then receive their first HydraScalp Keravive™ treatment, followed immediately application of the IP, after which post-treatment photographs and HairMetrix images will be taken. A Technician will provide the Subject with the IP, Subject Instructions (including treatment instructions), and a Daily-Use Diary before the visit ends. At Visit 2 (V2), Subjects will report to the study site approximately 4 weeks (W4) after their BL visit. Dermatologist and Subject tolerability assessments will be performed, followed by pre-treatment clinical photography and HairMetrix imaging. Subjects will receive their second HydraScalp Keravive™ treatment followed by IP application, and post-treatment clinical photography and HairMetrix imaging will be performed. Subjects will complete an SAQ before the visit ends. At Visit 3 (V3), Subjects will report to the study site approximately 8 weeks (W8) after their BL visit. The same procedures will be performed as at the W4 visit, including the third and final HydraScalp Keravive™ treatment.
At Visit 4 (V4), Subjects will report to the study site approximately 12 weeks (W12) after their BL visit. No HydraScalp Keravive™ treatment will be performed at this visit. Dermatologist and Subject tolerability assessments, clinical photography, and HairMetrix imaging will be performed. Subjects will complete a final SAQ, QOL questionnaire, product attributes questionnaire, and testimonial. Subject's participation in the study will end.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Female or male, 30 to 50 years of age.
- Fitzpatrick skin types I-VI.
- Is in good general health (physical, mental, and social well-being; not merely the absence of disease); as determined by the PI, based on medical history reported by the Subject.
- Has self-perceived moderate to severe thinning hair, either in one area of the scalp or in several areas of the scalp.
- Female Subjects: has a score of "I-2" through "Frontal" on the Ludwig Scale, as confirmed by a board-certified dermatologist.
- Male Subjects: has a score of "2" through "4" on the Norwood Scale, as confirmed by a board-certified dermatologist.
- Has mild to moderate scalp irritation, defined as a score of 1 (mild) or 2 (moderate) on a 4-point scale for Redness, Dryness, Flaking or Dandruff, and Bumps, as determined by a board-certified dermatologist.
- Willing to receive three (3) HydraScalp Keravive™ treatments spaced approximately one (1) month apart (BL, W4, and W8).
- Willing to use only the study scalp serum on the scalp throughout the study, once daily (morning or evening) plus after every HydraScalp Keravive™ treatment, and to not use any other scalp serum (cosmeceutical or physician-dispensed products).
Exclusion Criteria:
- Has scalp severe Redness, Dryness, Flaking, or Bumps scores of 3 (severe) on a 4-point scale, confirmed by a board-certified dermatologist.
- Has a scalp severe Itching, Burning, or Stinging score of 3 (severe) on a 4-point scale, as reported by the Subject.
- Has any active scalp disease as determined by the Dermatologist (e.g., scalp psoriasis, seborrheic dermatitis, tinea capitis, folliculitis) or any other disease which may interfere, in the Dermatologist's judgement.
- Mild to moderate flaking/dandruff meeting Inclusion Criterion 7 is not exclusionary.
- Has been diagnosed with Alopecia Areata.
- Has hair extensions, weaves, or tight hair styles.
- Regularly wears their hair braided or pulled tightly back.
- Regularly wears wigs and is unwilling to not wear a wig during the study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Scalp Serum
Scalp Serum to be applied immediately after HydraScalp Treatment and once daily in the AM or PM on Wet or Dry hair. |
Subjects will receive 3 Hydrascalp Keravive Treatments spaced 1 month apart perofrmed by a licensed aesthetician |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Improvement in the appearance of thicker, fuller hair, as measured by clinical photography
Časové okno: Week 4, Week 8, and Week 12.
|
Improvement in the appearance of thicker, fuller hair will be measured by Canfield HairMetrix® image analysis and clinical photography at Weeks 4, 8, and 12 compared to baseline, following three (3) HydraScalp Keravive™ treatments paired with once-daily use of the Sponsor's scalp serum. Clinical photography will be assessed for visual improvement in thicker, fuller hair. Canfield HairMetrix images will be analyzed for improvements in hair density, where an increase in score indicates improvement. |
Week 4, Week 8, and Week 12.
|
|
Improvement in hair and scalp attributes measured by subjects through a self-assessment questionnaire
Časové okno: Week 4, Week 8, and Week 12.
|
Subjects will complete a self-assessment questionnaire to evaluate perceived improvement in hair and scalp attributes at Weeks 4, 8, and 12. Subjects will be asked to rate a series of statements on a 5 point scale: 1-completely disagree, 2-slightly disagree, 3- neither disagree or agree, 4- agree, and 5-completely agree. The best outcome is to Completely Agree with the statement / question being asked. |
Week 4, Week 8, and Week 12.
|
|
Improvement in subject quality of life measured by a questionnaire
Časové okno: Week 12
|
Improvement in Quality of Life (QOL) questionnaire at Week 12 compared to baseline. Subjects will be asked to rate a series of statements on a 5 point scale: 1-completely disagree, 2-slightly disagree, 3- neither disagree or agree, 4- agree, and 5-completely agree. A shift from score 4 - 5 at baseline to score 1 - 3 at post baseline timepoints would indicate an improvement. |
Week 12
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Scalp tolerability measured by objective and subjective parameters on a 4 point scale
Časové okno: Week 4, 8, and 12
|
Scalp tolerability will be assessed for signs and symptoms of the following objective and subjective irritation parameters. Objective irritation (clinically graded): erythema, dryness, flaking/ dandruff, and bumps. Subjective irritation (assessed by subjects): burning, stinging, and itching. Tolerability will be evaluated using a 4-point scale (0 = none to 3 = severe) at Weeks 4, 8, and 12 compared to baseline. A decrease in value indicates an improvement. |
Week 4, 8, and 12
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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