Skin PigmentNCT06657352
Skin Efficacy Testing of Astrion Products
A study testing ACS Topical Treatment Group, Oral Treatment + Topical Treatment Group and ACS Oral Treatment Group in people with Skin Pigment and Skin Red, run by Chia Nan University of Pharmacy ＆ Science at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Pigment, Skin Red
- What is being tested?
- ACS Topical Treatment Group, Oral Treatment + Topical Treatment Group and ACS Oral Treatment Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Nov 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged ≥18 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Skin Pigment, Skin Red
- Being tested
- ACS Topical Treatment Group, Topical Placebo Group, Oral Treatment + Topical Treatment Group, ACS Oral Treatment Group, Oral Placebo Group
- Medical subject headings
- Pigmentation Disorders, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACS Topical Treatment GroupDietary supplement
The topical group applied the ACS cream to the face twice daily (morning and night) for 4 weeks.
Topical Placebo GroupDietary supplement
The topical group applied the cream (without ACS) to the face twice daily (morning and night) for 4 weeks.
Oral Treatment + Topical Treatment GroupDietary supplement
The combination group used both the topical and oral ACS products for 12 weeks.
ACS Oral Treatment GroupDietary supplement
The oral group ingested one ACS capsule twice daily after breakfast and dinner for 12 weeks.
Oral Placebo GroupDietary supplement
The oral group ingested one capsule (without ACS) twice daily after breakfast and dinner for 12 weeks.
Oral Treatment + Topical Placebo GroupDietary supplement
The combination group used both the topical and oral products without ACS for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ACS Topical Treatment Group | Experimental | 25 participants, measured at Week 0, 2, 4. Receives: Dietary Supplement: ACS Topical Treatment Group |
| Topical Placebo Group | Placebo comparator | 25 participants, measured at Week 0, 2, 4. Receives: Dietary Supplement: Topical Placebo Group |
| ACS Oral Treatment Group | Experimental | 25 participants, measured at Week 0, 2, 4, 8, 12. Receives: Dietary Supplement: ACS Oral Treatment Group |
| Oral Placebo Group | Placebo comparator | 25 participants, measured at Week 0, 2, 4, 8, 12. Receives: Dietary Supplement: Oral Placebo Group |
| ACS Oral Treatment + ACS Topical Treatment Group | Experimental | 25 participants, measured at Week 0, 2, 4, 8, 12. Receives: Dietary Supplement: Oral Treatment + Topical Treatment Group |
| ACS Oral Treatment + Topical Placebo Group | Placebo comparator | 25 participants, measured at Week 0, 2, 4, 8, 12. Receives: Dietary Supplement: Oral Treatment + Topical Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin melanin
Skin elastometer (Soft Plus) was utilized to measure skin melanin. Units: arbitrary units
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start28 Nov 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin PigmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Nan University of Pharmacy ＆ Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657352
- Sponsor's protocol ID
- TSMHIRB22-111-A
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Efficacy Testing of Astrion Products
- ClinicalTrials.gov ID
- NCT06657352
- Acronym / sponsor ID
- TSMHIRB22-111-A
- Conditions
- Skin Pigment, Skin Red
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Chia Nan University of Pharmacy ＆ ScienceUniversity, hospital or other
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ACS Topical Treatment Group | Experimental | Dietary Supplement: ACS Topical Treatment Group25 participants, measured at Week 0, 2, 4. |
| Topical Placebo Group | Placebo comparator | Dietary Supplement: Topical Placebo Group25 participants, measured at Week 0, 2, 4. |
| ACS Oral Treatment Group | Experimental | Dietary Supplement: ACS Oral Treatment Group25 participants, measured at Week 0, 2, 4, 8, 12. |
| Oral Placebo Group | Placebo comparator | Dietary Supplement: Oral Placebo Group25 participants, measured at Week 0, 2, 4, 8, 12. |
| ACS Oral Treatment + ACS Topical Treatment Group | Experimental | Dietary Supplement: Oral Treatment + Topical Treatment Group25 participants, measured at Week 0, 2, 4, 8, 12. |
| ACS Oral Treatment + Topical Placebo Group | Placebo comparator | Dietary Supplement: Oral Treatment + Topical Placebo Group25 participants, measured at Week 0, 2, 4, 8, 12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects aged ≥18 years.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACS Topical Treatment GroupThe topical group applied the ACS cream to the face twice daily (morning and night) for 4 weeks. | Dietary supplement | ACS Topical Treatment Group |
| Topical Placebo GroupThe topical group applied the cream (without ACS) to the face twice daily (morning and night) for 4 weeks. | Dietary supplement | Topical Placebo Group |
| Oral Treatment + Topical Treatment GroupThe combination group used both the topical and oral ACS products for 12 weeks. | Dietary supplement | ACS Oral Treatment + ACS Topical Treatment Group |
| ACS Oral Treatment GroupThe oral group ingested one ACS capsule twice daily after breakfast and dinner for 12 weeks. | Dietary supplement | ACS Oral Treatment Group |
| Oral Placebo GroupThe oral group ingested one capsule (without ACS) twice daily after breakfast and dinner for 12 weeks. | Dietary supplement | Oral Placebo Group |
| Oral Treatment + Topical Placebo GroupThe combination group used both the topical and oral products without ACS for 12 weeks. | Dietary supplement | ACS Oral Treatment + Topical Placebo Group |
Primary outcome
skin melanin
Time frame: 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 elastometer (Soft Plus) was utilized to measure skin melanin. Units: arbitrary units
Skin brightness
Time frame: 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 color difference analyzer (Chroma Meter MM500) was utilized to measure skin brightness
skin moisture
Time frame: 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 meter (Corneometer CM825) was utilized to measure skin moisture. Units: arbitrary units
skin elasticity
Time frame: 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 elastometer (Soft Plus) was utilized to measure skin elasticity. Units: arbitrary units
collagen density content
Time frame: 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
Subcutaneous collagen scanner (DermaLab® Series SkinLab Combo) was utilized to measure skin collagen. Units: arbitrary units
skin surface topography
Time frame: 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
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin texture. Units: arbitrary units
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACS Topical Treatment Group, Oral Treatment + Topical Treatment Group and ACS Oral Treatment Group in people with Skin Pigment and Skin Red, run by Chia Nan University of Pharmacy ＆ Science at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin melanin (time frame: 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.