Healthy adult
Conditions
Interventions
Using test article for 16 consecutive weeks
Sponsors
ROHTO PHARMACEUTICAL CO.,LTD.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Japanese female subjects aged 40 years or older and younger than 60 years at the time of consent. 2.Subjects who have recently become concerned about hair thinning and/or hair loss. 3.Subjects who perceive a decrease in hair volume and/or experience discomfort in hair manageability (e.g., when running fingers through the hair). 4.Subjects classified as Ludwig classification type I-2 through type II-1. 5.Subjects who have received a sufficient explanation regarding the purpose and details of this study, are capable of providing informed consent, fully understand the information provided, and voluntarily agree in writing to participate in this study.
Exclusion criteria
Exclusion criteria: 1.Subjects who have undergone hair transplantation or who are wearing wigs or hairpieces on the scalp evaluation area. 2.Subjects who present with inflammation or dermatological disease on the scalp evaluation area. 3.Subjects who have factors at the scalp evaluation area that may affect the study results (e.g., urticaria, inflammatory conditions, eczema, trauma, acne, pimples, warts, pigmentation, or residual traces of these conditions). 4.Subjects with a past or current history of atopic dermatitis, or those with an atopic diathesis. 5.Subjects who have previously received aesthetic medical procedures at the scalp evaluation area (e.g., botulinum toxin injections, hyaluronic acid or collagen fillers, photofacial therapy), or who plan to undergo such procedures during the study period. 6.Subjects who have received, within the past 4 weeks, or plan to receive during the study period, special skincare treatments to the scalp evaluation area (e.g., beauty salon treatments, esthetic procedures, head spa). 7.Subjects who are continuously using skincare products, cosmetics, quasi-drugs, health foods, topical preparations (pharmaceuticals or quasi-drugs), or oral medications that claim efficacy similar to or related to the efficacy being investigated in this study (e.g., hair growth effects). 8.Subjects who have used, within the past 4 weeks, health foods or supplements (e.g., products containing saw palmetto or zinc), or hair care products (e.g., shampoos, conditioners, treatments, hair essences, or hair growth agents) that claim hair growth, hair restoration, or anti-hair loss effects (for hair growth agents, within the past 6 months). 9.Subjects who are using cosmetics applied to the scalp evaluation area (e.g., hair tonics). And others (omitted due to overcapacity).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| evaluation of scalp condition | — |
Countries
Japan
Contacts
Public ContactYasunari Sato
ROHTO PHARMACEUTICAL CO.,LTD. External Medicine & Hair Care Product Development Division
Outcome results
None listed