- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07271199
Eyelash Effect Evaluation for Premium Rejuvenation Eyelash Serum
Evaluation of the Eyelash Care Effects of Premium Rejuvenation Eyelash Serum
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective, randomized, double-blinded, placebo-controlled study aims to investigate the effects of Premium Rejuvenation Eyelash Serum on eyelashes and surrounding periorbital skin. A total of 30 healthy female adults aged 18 to 60 will be enrolled. Inclusion criteria require participants to be free from chronic diseases, major illnesses (including cancer, stroke-related disorders, paralysis, acute myocardial infarction, coronary artery bypass surgery, end-stage renal disease, or major organ/hematopoietic stem cell transplants), and allergic constitutions. Exclusion criteria include current use of medications or eyelash care products.
Participants will be randomly assigned into two groups of 15 each: Group 1 uses placebo (Base formula without active ingredient); Group 2 uses the experimental formula with ginger (Zingiber officinale)-derived extracellular vesicle + turmeric (Curcuma longa)-derived extracellular vesicles + IGF-1 + FGF-7. . Baseline assessments will be conducted prior to product use. Follow-up assessments will occur at Days 28 (4 weeks), 56 (8 weeks), 84 (12 weeks), and 112 (16 weeks). Evaluations will include eyelash density, change in eyelash length, self-reported periorbital skin condition (e.g., swelling, irritation, pigmentation, redness, and allergic reactions), and a questionnaire. Eyelash parameters will be objectively measured using the Canfield Scientific VISIA® Skin Analysis System. At the conclusion of the study (Day 112), both participant self-assessments and evaluations by an eyelash specialist will be conducted to assess eyelash and surrounding skin condition.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taichung, Taiwan, 433304
- Hungkuang University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy female adults from the age of 18 to 60 years (inclusive).
- Having symptoms of alopecia, baldness, or self-identified with hair thinning.
- Absence of chronic diseases, major illnesses, or allergies.
- Major illnesses include cancer, post-stroke disorders, paralysis, acute myocardial infarction, coronary artery bypass surgery, end-stage renal disease, and major organ transplant or hematopoietic stem cell transplant
Exclusion Criteria:
- Currently taking any medication or using any eyelash care products.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Group 1: Placebo control
Base formula without active ingredient
|
Placebo Control (Base Formula without active ingredients).
After thoroughly cleansing the face and removing contact lenses (if applicable), apply 1 mL of the serum evenly to the base of the eyelashes.
Allow the serum to absorb for a few minutes.
Repeat application twice daily, in the morning and evening.
|
|
Experimental: Group 2: Experimental formula
Base formula with ginger (Zingiber officinale)-derived extracellular vesicle, turmeric (Curcuma longa)-derived extracellular vesicles, insulin growth factor-1 (IGF-1), and fibroblast growth factor-7 (FGF-7).
|
Base formula with ginger (Zingiber officinale)-derived extracellular vesicle, turmeric (Curcuma longa)-derived extracellular vesicles, insulin growth factor-1 (IGF-1), and fibroblast growth factor-7 (FGF-7). After thoroughly cleansing the face and removing contact lenses (if applicable), apply 1 mL of the serum evenly to the base of the eyelashes. Allow the serum to absorb for a few minutes. Repeat this application twice daily, in the morning and evening. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eyelash density
Time Frame: Assessment conducted every 28 days from Day 0 to Day 112 (including Day 0 as baseline)
|
Assess eyelash density with Canfield VISIA® Skin Analysis system by assigning score from 1 (most dense, thick eyelashes) to 5 (least dense, thin eyelashes).
Results will be expressed as percentage of change in eyelash density percentage relative to Day 0.
|
Assessment conducted every 28 days from Day 0 to Day 112 (including Day 0 as baseline)
|
|
Eyelash length
Time Frame: Assessment conducted every 28 days from Day 0 to Day 112 (including Day 0 as baseline)
|
Assess eyelash length with Canfield VISIA® Skin Analysis system by assigning score from 1 (longest eyelashes) to 5 (shortest eyelashes).
Results will be expressed as percentage of change in eyelash length percentage relative to Day 0
|
Assessment conducted every 28 days from Day 0 to Day 112 (including Day 0 as baseline)
|
|
Periorbital skin and eye conditional questionnaire
Time Frame: Assessment conducted every 28 days from Day 0 to Day 112 (including Day 0 as baseline)
|
Participants will be asked to answer a questionnaire for self-assessment of periorbital skin conditions such as swelling, irritation, pigmentation, redness, and allergic reaction; corneal and retinal conditions including swelling, hyperemia, and allergic reaction will also be self-evaluated.
|
Assessment conducted every 28 days from Day 0 to Day 112 (including Day 0 as baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant self-assessment
Time Frame: Day 112 (End of the study period)
|
Participants will be asked to fill out an assessment form with score from 0 to 4 for each of the eyelash condition and product feedback evaluated.
|
Day 112 (End of the study period)
|
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Eyelash specialist assessment
Time Frame: Day 112 (End of the study)
|
An eyelash specialist will assess and eyelash and periorbital skin condition of the participant and assign a score from 0 to 4 for each of the evaluated items as well as assign a score of Global Aesthetic Improvement Scale (GAIS) from -1 to 3.
|
Day 112 (End of the study)
|
Collaborators and Investigators
Sponsor
Collaborators
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-089-A
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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