Functional Test for a Drink Powder Alone and Combined Use With a Cosmetic Apparatus

Pharmanex

Status: Completed

Conditions: Skin Elasticity; Skin Firmness; Beauty Drink Powder; Skin Moisture; Skin Dryness; Cosmetic Apparatus on Skin; Skin Evenness

Treatments: Device: Cosmetic apparatus; Dietary Supplement: Beauty drink powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT05041205

C210201

Details and patient eligibility

About

This study is designed to observe human consuming effect of a beauty drink powder and combined use with a cosmetic apparatus. It is a randomized, double-blind, and placebo-control study. The target enrollment of subjects is 160 and 4 arms are included, a placebo control, drink powder alone, cosmetic apparatus alone, and drink powder plus cosmetic apparatus. Effects on skin dullness, skin tone unevenness, skin dryness, skin elasticity, wrinkle and fine line are evaluated. Both objective and subjective methods are used for efficacy evaluation. Data are collected at baseline, week 4, week 8, and week 12 after treatment.

Full description

In this study, objective parameters are measured by the instruments as following: VisioScan VC20 is used for skin roughness and wrinkle assessment, chromameter CR-400 is used to assess skin color, skin gloss is assessed by Glossymeter, skin hydration is assessed by Corneometer, TEWL is assessed by Vapometer, and skin elasticity is assessed by Cutometer. VISIA-CR and VISIA-7 are used in skin radiation and wrinkle visualization.

Clinical assessment is performed by expert visual grading on

• Skin evenness
• Skin radiance
• Skin elasticity
• Skin smoothness
• Skin firmness
• Skin moisture
• Skin plumpness

Enrollment: 160 patients

Sex: All

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Chinese healthy male or female
• Subjects with skin problems such as skin dullness, skin tone unevenness, skin inelasticity, skin dryness, and wrinkle/fine lines.
• Subjects without any other chronic or on treatment diseases
• Subjects are voluntary to participate the trial and signed informed consents.
• Subjects are voluntary to follow all evaluation criteria

Exclusion criteria

• Subjects have a plan to be pregnant, or are in pregnancy or lactation period;
• Not participated any clinical trial or evaluation within nearly 1 month;
• Used anti-histamine medication within nearly one week or immunosuppressor within nearly one month
• Used any anti-inflammation drugs at test site within nearly two months
• Subjects who have any skin diseases (psoriasis, eczema, skin cancer etc.)
• Subjects with Type I diabetes
• Subjects who currently are receiving asthma or other chronic respiratory diseases treatment
• Subjects who are receiving anti-cancer chemotherapy in nearly 6 months
• Subjects who have anyother health problem or chronic diseases
• Subjects who have externally used Vit A, a-hydroxy acid, salicylic acid, hydroquinone within nearly 3 months or prescription medicines, oral contraceptive within nearly 6 months
• Expert or professional person evaluate have other iatrogenic reason may impact the evaluation results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 4 patient groups, including a placebo group

Placebo control group

Placebo Comparator group

Description:

placebo drink powder without active ingredients, 1 sachet per day with 50 ml water for 12 weeks

Treatment:

Dietary Supplement: Beauty drink powder

Beauty drink powder group

Experimental group

Description:

Beauty drink powder is the test article provide to participants, 1 sachet per day with 50 ml water for 12 weeks

Treatment:

Dietary Supplement: Beauty drink powder

cosmetic apparatus group

Placebo Comparator group

Description:

This group is designed for a cosmetic apparatus control group without consumption of placebo or test article. Together with the specified cleanser, the apparatus is used for daily facial cleaning, two times in the morning and evening for 12 weeks.

Treatment:

Device: Cosmetic apparatus

Beauty drink powder + cosmetic apparatus group

Experimental group

Description:

In this group, Beauty drink powder is consumed 1 sachet daily with 50 ml water and the cosmetic apparatus is used together with the specified cleanser for daily facial cleaning, two times in the morning and evening for 12 weeks.

Treatment:

Device: Cosmetic apparatus

Dietary Supplement: Beauty drink powder