## Protocol Section
### Identification Module
**NCT ID:** NCT06422026

**Brief Title:** 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

#### Organization Study ID Info
**ID:** AP-PV-2022-02
#### Organization
**Class:** INDUSTRY
**Full Name:** Amorepacific Corporation
### Status Module
#### Completion Date
**Date:** 2024-04-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-01-30

**Type:** ACTUAL

#### Start Date
**Date:** 2023-03-16

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Amorepacific Corporation

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Hair Damage

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 150

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Dietary Supplement: APCP I

**Label:** APCP I

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Dietary Supplement: APCP II

**Label:** APCP II

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Intervention Names:**

- Dietary Supplement: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- APCP I

**Description:** Each subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 3 g.

**Name:** APCP I

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- APCP II

**Description:** Each subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 4 g.

**Name:** APCP II

**Type:** DIETARY_SUPPLEMENT

#### Intervention 3

**Arm Group Labels:**

- Placebo

**Description:** Each subject takes one active bottle per day for 24 weeks.

**Name:** Placebo

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Hair tensile strength measured by UTM(Universal Testing Machine) etc.

**Measure:** Change from baseline in hair tensile strength

**Time Frame:** Baseline, 24 week

#### Secondary Outcomes

**Description:** Hair gloss measured by Glossymeter etc.

**Measure:** Change from baseline in hair gloss

**Time Frame:** Baseline, 24 week

**Description:** Hair density measured by Folliscope

**Measure:** Change from baseline in hair density

**Time Frame:** Baseline, 24 week

**Description:** Hair volume measured by I Max-plus

**Measure:** Change from baseline in hair volume

**Time Frame:** Baseline, 24 week

**Description:** 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).

**Measure:** Change from baseline in satisfaction survey

**Time Frame:** Baseline, 24 week

**Description:** scalp moisture measured by DermaLab Hydration Pin Probe

**Measure:** Change from baseline in scalp moisture

**Time Frame:** Baseline, 24 week

**Description:** scalp percutaneous moisture loss measured by Tewameter TM Nano

**Measure:** Change from baseline in scalp percutaneous moisture loss

**Time Frame:** Baseline, 24 week

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Yonsei University Health System, Severance Hospital

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
