Evaluated the Efficacy and Safety of APCP on Hair Health

A 24 Week, Randomized, Double Blind, Placebo Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of APCP on Hair Health

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.

Study Overview

• Status: Completed
• Conditions: Hair Damage
• Intervention / Treatment: Dietary supplement: APCP I; Dietary supplement: APCP II; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University Health System, Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Each subject takes one active bottle per day for 24 weeks.
Active Comparator: APCP I	Dietary supplement: APCP I; Each subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 3 g.
Active Comparator: APCP II	Dietary supplement: APCP II; Each subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 4 g.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in hair tensile strength	Hair tensile strength measured by UTM(Universal Testing Machine) etc.	Baseline, 24 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in hair gloss	Hair gloss measured by Glossymeter etc.	Baseline, 24 week
Change from baseline in hair density	Hair density measured by Folliscope	Baseline, 24 week
Change from baseline in hair volume	Hair volume measured by I Max-plus	Baseline, 24 week
Change from baseline in scalp moisture	scalp moisture measured by DermaLab Hydration Pin Probe	Baseline, 24 week
Change from baseline in scalp percutaneous moisture loss	scalp percutaneous moisture loss measured by Tewameter TM Nano	Baseline, 24 week
Change from baseline in satisfaction survey	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).	Baseline, 24 week

Collaborators and Investigators

• Sponsor: Amorepacific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2023
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AP-PV-2022-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No