Hair and scalp irritation, cosmetic product safety, hair conditioning efficacy, and user satisfaction in healthy human volunteers. Hair care, Cosmetic safety, Healthy volunteers, Hair irritation, Scalp irritation, Hair conditioning efficacy, User satisfaction, Cocoa butter, Cocoa seed shell extract
Conditions
Interventions
Dosage and Usage
Short hair (around neck length): Use about 0.5 g (approximately the size of a 10-baht coin).
Medium hair (shoulder to mid-back length): Use about 1 g (approximately the size of two
Active Comparator Drug,Placebo Comparator No treatment
hair cream containing cocoa bean shell extract and cocoa butter,Control
Sponsors
National Research Council of Thailand (NRCT)
Eligibility
Sex/Gender
All
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: 1.Age: Volunteers between eighteen and forty-nine years, both female and male 2.General health: Must be in good health, without chronic skin diseases, wounds, or inflammation at the test area (behind the ear); participants with dry, oily, or normal hair are acceptable 3.Ability to comply with study procedures: Willing to cooperate and able to attend follow-up visits as scheduled 4.Voluntary participation: Informed about the study and signed the informed consent form
Exclusion criteria
Exclusion criteria: 1.History of allergy or hypersensitivity to related substances, including cocoa butter, cocoa seed coat extract, or other ingredients in the product, or history of allergy to chemicals in hair care products such as fragrances 2.Presence of skin diseases or conditions that may affect the test results, such as atopic dermatitis, psoriasis, eczema, seborrheic dermatitis, open wounds, infections, or inflammation at the test area (behind the ear) 3.Use of medications or products that may affect the hair, scalp, or test outcomes, such as anti-hair loss treatments (e.g., finasteride, dutasteride, minoxidil), corticosteroids, antihistamines, hormonal drugs, or hair care products with hair growth stimulating or scalp altering effects within three months prior to study participation 4.Health conditions that may interfere with the study, including immunodeficiency disorders such as systemic lupus erythematosus (SLE), uncontrolled diabetes, or history of severe allergy (anaphylaxis) 5.Pregnancy or breastfeeding, due to hormonal changes that may influence skin responses 6.Inability to comply with study requirements, such as failure to attend follow-up visits as scheduled or inability to follow investigator instructions 7.Participation in other product testing during the same period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erythema After using the cream: at 30 minutes and 24 hours, respectively. Examination by digital skin analyzer | — |
Secondary
| Measure | Time frame |
|---|---|
| Satisfaction Assessments were conducted at 14 days after cream application. Self-administered questionnaire | — |
Countries
Thailand
Contacts
Public ContactChutima Limmatvapirat
Faculty of Pharmacy, Silpakorn University
Outcome results
None listed