Clinical trial NCT06422026: Evaluated the Efficacy and Safety of APCP on Hair Health
Official title: A 24 Week, Randomized, Double Blind, Placebo Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of APCP on Hair Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Damage
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2024-05-20
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in hair tensile strength
timeFrame: Baseline, 24 week
Secondary outcomes:
measure: Change from baseline in hair gloss
timeFrame: Baseline, 24 week
measure: Change from baseline in hair density
timeFrame: Baseline, 24 week
measure: Change from baseline in hair volume
timeFrame: Baseline, 24 week
measure: Change from baseline in satisfaction survey
timeFrame: Baseline, 24 week
measure: Change from baseline in scalp moisture
timeFrame: Baseline, 24 week
measure: Change from baseline in scalp percutaneous moisture loss
timeFrame: Baseline, 24 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
References: