- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07622160
Efficacy Test of a Moisturizing and Anti-aging Facial Mask
Efficacy Test of a Moisturizing and Anti-aging Facial Mask for Skin Improvement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a single-center, self-controlled human trial designed to evaluate the skin beauty effect of Moisturizing facial mask and Anti-aging facial mask.
Healthy adult participants aged above 18 years will be enrolled. Participants will be informed to apply the facial mask on whole face three times per week for 4 consecutive weeks. Skin measurement and self-assessment questionnaires will be conducted at baseline (before intake), after single use, and after continuous use for 2 and 4 weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pingdong, Taiwan
- Chia Nan University of Pharmacy & Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants aged 18 years or older
Exclusion Criteria:
- Non-voluntary participants.
- Individuals diagnosed by a physician with skin diseases, liver cirrhosis, or chronic renal failure.
- Individuals with known allergies to cosmetics, medications, or foods.
- Pregnant or breastfeeding individuals.
- Individuals taking medications for chronic diseases.
- Students taught or supervised by the principal investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hydrating Repairing Mask
|
Applying the facial mask three times per week for a continuous period of 4 weeks
Other Names:
|
|
Experimental: Anti-aging Rejuvenating Mask
|
Applying the facial mask three times per week for a continuous period of 4 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change of skin hydration
Time Frame: Change from Baseline skin hydration at 4 weeks
|
Corneometer® CM825 (CK, Germany) was utilized to measure skin surface hydation.
Units: arbitrary Corneometer® units 0-120.
|
Change from Baseline skin hydration at 4 weeks
|
|
The change of skin redness
Time Frame: Change from Baseline skin redness at 4 weeks
|
Chroma Meter MM500 was utilized to measure face skin redness.
Units: a* value
|
Change from Baseline skin redness at 4 weeks
|
|
The change of skin texture
Time Frame: Change from Baseline skin texture at 4 weeks
|
VISIA Complexion Analysis was utilized to measure skin texture.
Units: arbitrary units
|
Change from Baseline skin texture at 4 weeks
|
|
The change of skin wrinkles
Time Frame: Change from Baseline skin wrinkles at 4 weeks
|
VISIA Complexion Analysis was utilized to measure skin wrinkles.
Units: arbitrary units
|
Change from Baseline skin wrinkles at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change of transepidermal water loss (TEWL)
Time Frame: Change from Baseline TEWL at 4 weeks
|
Tewameter® TM300 (CK, Germany) was utilized to measure TEWL.
Units: g/hm²
|
Change from Baseline TEWL at 4 weeks
|
|
The change of skin tone
Time Frame: Change from Baseline skin tone at 4 weeks
|
Chroma Meter MM500 was utilized to measure face skin tone.
Units: Individual Typology Angle (ITA°)
|
Change from Baseline skin tone at 4 weeks
|
|
The change of skin pores
Time Frame: Change from Baseline skin pores at 4 weeks
|
VISIA Complexion Analysis was utilized to measure skin pores.
Units: arbitrary units
|
Change from Baseline skin pores at 4 weeks
|
|
The change of skin elasticity
Time Frame: Change from Baseline skin elasticity at 4 weeks
|
Skin elasticity (Softplus, Italy) was utilized to measure face skin elasticity.
Units: arbitrary units
|
Change from Baseline skin elasticity at 4 weeks
|
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The change of skin collagen density
Time Frame: Change from Baseline skin collagen density at 4 weeks
|
DermaLab® Series SkinLab Combo was utilized to measure skin collagen density.
Units: arbitrary units
|
Change from Baseline skin collagen density at 4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change of self-assessment skin condition
Time Frame: Change from Baseline skin condition at 4 weeks
|
Skin condition was evaluated using a 5-point Likert scale (0-4) to assess the severity of skin-related symptoms.
The scale was defined as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
|
Change from Baseline skin condition at 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chia-Hua Liang, Ph.D., Chia Nan University of Pharmacy & Science
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMANH114-REC056
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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