Evaluated the Efficacy and Safety of APCP on Hair Health
Not Applicable
Completed
- Conditions
- Hair Damage
- Interventions
- Dietary Supplement: APCP IIDietary Supplement: PlaceboDietary Supplement: APCP I
- Registration Number
- NCT06422026
- Lead Sponsor
- Amorepacific Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description APCP II APCP II - Placebo Placebo - APCP I APCP I -
- Primary Outcome Measures
Name Time Method Change from baseline in hair tensile strength Baseline, 24 week Hair tensile strength measured by UTM(Universal Testing Machine) etc.
- Secondary Outcome Measures
Name Time Method Change from baseline in hair density Baseline, 24 week Hair density measured by Folliscope
Change from baseline in scalp moisture Baseline, 24 week scalp moisture measured by DermaLab Hydration Pin Probe
Change from baseline in hair gloss Baseline, 24 week Hair gloss measured by Glossymeter etc.
Change from baseline in hair volume Baseline, 24 week Hair volume measured by I Max-plus
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).
Trial Locations
- Locations (1)
Yonsei University Health System, Severance Hospital
🇰🇷Seoul, Korea, Republic of