Clinical trial NCT04733755: Beauty Image Efficacy Study
Official title: Beauty Image Efficacy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Lead sponsor: Pharmanex
Sponsor class: INDUSTRY
First posted: 2021-02-02
Enrollment: 80
Sex: ALL
Minimum age (years): 28
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to evaluate the effects of oral supplement of a blend containing collagen peptides, phosphatidylserine, Saussurea involucrata and lutein (Beauty Image) on the improvement of skin aging in terms of hydration, gloss, melanin content, roughness and wrinkling, and anti-UV performance.


Eligibility criteria: Inclusion Criteria:

* Facial skin with problems of dull, uneven, inelastic, dryness and wrinkle/fine line (At least fit to two problems)
* In general good health and good mental state;
* Willing to read, understand and able to sign the Informed Consent Form;
* Willing to comply with all study protocol requirements.

Exclusion Criteria:

* Intention to become pregnant, pregnant, lactating or within 6 months of delivery;
* Participation in any clinical test or cosmetic product test on skin within 30 days;
* Existence of neurodermatitis, pityriasis, seborrheic dermatitis or psoriasis capitis on test area;
* Use of any anti-inflammatory drugs in the past 2 months;
* A history of skin diseases such as psoriasis, eczema, psoriasis, skin cancer, etc.;
* IDDM: Insulin dependent diabetic patients;
* Current treatment for asthma or other chronic respiratory diseases;
* Undergoing anticancer chemotherapy in the past 6 months;
* Existence of any other health problems or chronic diseases;
* Use of retinoids, alpha hydroxyl acid, ortho-hydroxybenzoic acid, hydroquinone nearly within 3 months; or use of prescriptions (such as antibiotics, retinoids, alpha hydroxyl acid or steroids), oral contraceptives (Use of same contraceptives for 6 months excepted);
* Existence of the following conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, diabetes, vascular disease, hepatitis, eczema, psoriasis.

Primary outcomes:
measure: Change in facial photo from baseline at week 4 and week 8
timeFrame: Baseline, Week 4 and Week 8
measure: Change in skin roughness from baseline at week 4 and week 8
timeFrame: Baseline, Week 4 and Week 8
measure: Change in skin wrinkle from baseline at week 4 and week 8
timeFrame: Baseline, Week 4 and Week 8.
measure: Change in skin color from baseline at week 4 and week 8
timeFrame: Baseline, Week 4 and Week 8
measure: Change in melanin content from baseline at week 4 and week 8
timeFrame: Baseline, Week 4 and Week 8
measure: Change in skin gloss from baseline at week 4 and week 8
timeFrame: Baseline, Week 4 and Week 8.
measure: Change in skin hydration from baseline at week 4 and week 8
timeFrame: Baseline, Week 4 and Week 8.
measure: Change in transepidermal water Loss from baseline at week 4 and week 8
timeFrame: Baseline, Week 4 and Week 8.
measure: Change in skin elasticity from baseline at week 4 and week 8
timeFrame: Baseline, Week 4 and Week 8.
measure: Change in anti-ultraviolet from baseline at week 4 and week 8
timeFrame: Baseline, Week 4 and Week 8.
measure: Change in dermatologist grading of skin tone dullness from baseline at week 4 and week 8
timeFrame: Baseline, Week 4 and Week 8.
measure: Change in dermatologist grading of skin tone unevenness from baseline at week 4 and week 8
timeFrame: Baseline, Week 4 and Week 8.
measure: Change in dermatologist grading of skin dryness from baseline at week 4 and week 8
timeFrame: Baseline, Week 4 and Week 8.
measure: Change in dermatologist grading of skin inelastic from baseline at week 4 and week 8
timeFrame: Baseline, Week 4 and Week 8.
measure: Change in dermatologist grading of wrinkle/fine line from baseline at week 4 and week 8
timeFrame: Baseline, Week 4 and Week 8.
measure: Change in dermatologist grading of skin roughness from baseline at week 4 and week 8
timeFrame: Baseline, Week 4 and Week 8.
measure: Self Assessment
timeFrame: Baseline, Week 1, Week 2, Week 4 and Week 8.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Nu Skin (China) Daily-use & Health Products CO., LTD
state: Shanghai
Study officials:
References: