Tokyo, Oct. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059155) titled 'Clinical Study to Evaluate the Hair Growth Effects of a Hair Growth Agent' on Oct. 14.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - ROHTO PHARMACEUTICAL CO.,LTD.
Condition:
Condition - Healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To study the effectiveness of the hair growth agent for women with thinning hair.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Using test article for 16 consecutive weeks
Eligibility:
Age-lower limit - 40
years-old
Gender - Female
Key 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.
Key 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).
Target Size - 15
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 08 Day
Date of IRB - 2025 Year 09 Month 11 Day
Anticipated trial start date - 2025 Year 10 Month 14 Day
Last follow-up date - 2026 Year 02 Month 03 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067665
Disclaimer: Curated by HT Syndication.
