Hair growth trial

UMIN ID: UMIN000054607

Registered date:11/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adult men
• Date of first enrollment: 2024/06/11
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Take test food for 12 weeks+2 days.

Outcome(s)

• Primary Outcome: Photo Trichogram (Hair diameter, Hair growth rate, Anagen hair percentage)
• Secondary Outcome: General clinical examinations, Questionnaire survey, Head photography (top of head), Adverse event investigation

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 60years-old
• Gender: Male
• Exclude criteria: (1)Persons with inflammation or skin disease at the evaluation site (scalp). (2)Persons with factors that may affect the results of the test at the evaluation site (disease such as hives,inflammation,eczema,external wound,acne,pustules,warts,pigmented spots,etc.,or traces thereof). (3)Persons with a past medical history or current medical history of atopic dermatitis or persons with a predisposition to atopic dermatitis. (4)Persons who have received, or plan to receive during the study period, medical cosmetic treatment (Botox injections, hyaluronic acid or collagen injections, photo facials, etc.) to the evaluation site. (5)Persons who have undergone or will undergo within the past 4 weeks or during the study period any special skin care treatment (beauty salon, beauty treatment, head spa, etc.) for the evaluation site. (6)Persons are continuously using skin care products, cosmetics, quasi-drugs or health foods, topical products (pharmaceuticals and quasi-drugs), and oral medications (pharmaceuticals) with efficacy claims (hair growth efficacy) similar to or related to the efficacy studied in this study for the evaluation site. (7)Persons who have used health foods and basic skin care cosmetics, health foods and supplements (saw palmetto, zinc, etc.) used in the evaluation site or shampoos/conditioners/treatments that claim to be effective for hair growth, hair loss, or hair loss within the past 4 weeks. (8)Persons using cosmetics (hair tonic, etc.) on the evaluated site. (9)Persons who have been exposed to ultraviolet radiation beyond daily activities such as prolonged outdoor work, exercise, swimming, leisure activities, etc., within the past 4 weeks or plan to do so during the study period. (10)Persons working night shifts and day/night shifts. And others (omitted due to overcapacity).

Related Information

• Primary Sponsor: Oryza Oil&Fat Chemical.,Ltd.
• Source(s) of Monetary Support: Oryza Oil&Fat Chemical.,Ltd.