Skin Efficacy Testing of Astrion Products

This project aims to conduct safety and efficacy tests on the skin for the ingestion of Astrion Vitality Capsules, containing A. membranaceus and C. Asiatica roots, and the topical application of Astrion Vitality Cream. The goal is to develop health and skincare products that regulate physiological functions, promote overall wellness, and enhance skin beauty.

Study Overview

• Status: Completed
• Conditions: Skin Pigment; Skin Red
• Intervention / Treatment: Dietary supplement: ACS Topical Treatment Group; Dietary supplement: Topical Placebo Group; Dietary supplement: ACS Oral Treatment Group; Dietary supplement: Oral Placebo Group; Dietary supplement: Oral Treatment + Topical Treatment Group; Dietary supplement: Oral Treatment + Topical Placebo Group

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

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 71710
    • Chia Nan University of Pharmacy & Science

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Subjects aged ≥18 years.

Exclusion Criteria:

• Non-voluntary participants.
• Subjects diagnosed with skin diseases, cirrhosis, or chronic renal failure by a -physician.
• Individuals with known allergies to cosmetics, drugs, or food.
• Pregnant or breastfeeding women.
• Individuals taking medication for chronic diseases.
• Subjects who, within 12 weeks prior to the test, have undergone laser facial treatments, chemical peels, or experienced prolonged sun exposure (more than 3 hours of direct sunlight in a week).
• Students taught by the investigator.
• Individuals unwilling to allow the publication of photos of the experimental results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACS Topical Treatment Group; 25 participants, measured at Week 0, 2, 4.	Dietary supplement: ACS Topical Treatment Group; The topical group applied the ACS cream to the face twice daily (morning and night) for 4 weeks.
Placebo Comparator: Topical Placebo Group; 25 participants, measured at Week 0, 2, 4.	Dietary supplement: Topical Placebo Group; The topical group applied the cream (without ACS) to the face twice daily (morning and night) for 4 weeks.
Experimental: ACS Oral Treatment Group; 25 participants, measured at Week 0, 2, 4, 8, 12.	Dietary supplement: ACS Oral Treatment Group; The oral group ingested one ACS capsule twice daily after breakfast and dinner for 12 weeks.
Placebo Comparator: Oral Placebo Group; 25 participants, measured at Week 0, 2, 4, 8, 12.	Dietary supplement: Oral Placebo Group; The oral group ingested one capsule (without ACS) twice daily after breakfast and dinner for 12 weeks.
Experimental: ACS Oral Treatment + ACS Topical Treatment Group; 25 participants, measured at Week 0, 2, 4, 8, 12.	Dietary supplement: Oral Treatment + Topical Treatment Group; The combination group used both the topical and oral ACS products for 12 weeks.
Placebo Comparator: ACS Oral Treatment + Topical Placebo Group; 25 participants, measured at Week 0, 2, 4, 8, 12.	Dietary supplement: Oral Treatment + Topical Placebo Group; The combination group used both the topical and oral products without ACS for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
skin melanin	Skin elastometer (Soft Plus) was utilized to measure skin melanin. Units: arbitrary units	The topical group applied ACS cream to the face twice daily for 4 weeks. The oral group took one ACS capsule twice daily after meals for 12 weeks. The combination group followed both regimens for 12 weeks. A placebo group, identical in appearance but wit
Skin brightness	Skin color difference analyzer (Chroma Meter MM500) was utilized to measure skin brightness	The topical group applied ACS cream to the face twice daily for 4 weeks. The oral group took one ACS capsule twice daily after meals for 12 weeks. The combination group followed both regimens for 12 weeks. A placebo group, identical in appearance but wit
skin moisture	Skin moisture meter (Corneometer CM825) was utilized to measure skin moisture. Units: arbitrary units	The topical group applied ACS cream to the face twice daily for 4 weeks. The oral group took one ACS capsule twice daily after meals for 12 weeks. The combination group followed both regimens for 12 weeks. A placebo group, identical in appearance but wit
skin elasticity	Skin elastometer (Soft Plus) was utilized to measure skin elasticity. Units: arbitrary units	The topical group applied ACS cream to the face twice daily for 4 weeks. The oral group took one ACS capsule twice daily after meals for 12 weeks. The combination group followed both regimens for 12 weeks. A placebo group, identical in appearance but wit
collagen density content	Subcutaneous collagen scanner (DermaLab® Series SkinLab Combo) was utilized to measure skin collagen. Units: arbitrary units	The topical group applied ACS cream to the face twice daily for 4 weeks. The oral group took one ACS capsule twice daily after meals for 12 weeks. The combination group followed both regimens for 12 weeks. A placebo group, identical in appearance but wit
skin surface topography	VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin texture. Units: arbitrary units	The topical group applied ACS cream to the face twice daily for 4 weeks. The oral group took one ACS capsule twice daily after meals for 12 weeks. The combination group followed both regimens for 12 weeks. A placebo group, identical in appearance but wit

Collaborators and Investigators

• Sponsor: Chia Nan University of Pharmacy ＆ Science

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Pigmentation Disorders
• Other Study ID Numbers: TSMHIRB22-111-A

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