Hair Damage
Conditions
Brief summary
This study is designed to evaluate the efficacy and safety of APCP in promoting hair health in adult with mild to moderate hair damage, compared to a placebo control.
Interventions
DIETARY_SUPPLEMENTAPCP I
Each subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 3 g.
DIETARY_SUPPLEMENTAPCP II
Each subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 4 g.
DIETARY_SUPPLEMENTPlacebo
Each subject takes one active bottle per day for 24 weeks.
Sponsors
Amorepacific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Glossy scores according to the visual evaluation classification method correspond to 1 point or more and 3 points or less and a total hair damage score of less than 18 points evaluated according to exposure to risk factors * A person capable of maintaining the same hair shape and color during this human body application test * A person who has agreed to participate in this human application test before the start of the human application test and filled out the Informed Consent Form
Exclusion criteria
* A person currently being treated for infectious diseases and malignant tumors, including severe cardiovascular system, immune system, respiratory system, hepatometer, kidney and urology system, nervous system, musculoskeletal system, psychosis, skin, etc * As of Visit 1, those who currently have dull dermatitis, scalp psoriasis, and scalp infection * A person who plans to manage and operate hair supplies, hair products during this human body application test * A person who has taken oral Dutasteride or Finasteride within 6 months of visit 1 * A person who has applied topical hair growth agents, wool, and hair growth agents for the last 1 month (30 days) or more as of Visit 1 * Those who have been administered systemic steroids, cell death agents, vasodilators, antihypertensive agents, antiepileptic agents, beta receptor blockers, bronchodilators, diuretics, Cimetidine, Diazoxide, Cyclosporine, and Ketoconazole for the last 1 month or more (30 days) * A person who has applied topical steroids to the scalp for the last 1 month (30 days) or more as of Visit 1 * A person who has participated in other interventional clinical trials (including human application tests) within one month (30 days) of visit 1 or plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test * A person who is pregnant or who has a plan to become pregnant during the nursing mother or during this human body application test * A person who is sensitive to or allergic to food ingredients for this human body application test * A person who is deemed inappropriate by the tester for other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in hair tensile strength | Baseline, 24 week | Hair tensile strength measured by UTM(Universal Testing Machine) etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in hair density | Baseline, 24 week | Hair density measured by Folliscope |
| Change from baseline in hair volume | Baseline, 24 week | Hair volume measured by I Max-plus |
| Change from baseline in hair gloss | Baseline, 24 week | Hair gloss measured by Glossymeter etc. |
| Change from baseline in scalp moisture | Baseline, 24 week | scalp moisture measured by DermaLab Hydration Pin Probe |
| Change from baseline in scalp percutaneous moisture loss | Baseline, 24 week | scalp percutaneous moisture loss measured by Tewameter TM Nano |
| Change from baseline in satisfaction survey | Baseline, 24 week | Satisfaction surveys are evaluated on a 10-point scale. Survey items are evaluated on a scale from '0 - Not at all' to '10 - Very much so' (although scoring may be reversed depending on the question). |
Countries
South Korea
Outcome results
None listed