Combination of Oral and Topical Whitening Agents for Reducing Skin Pigmentation

USMARI Research & Innovation Centre

Status: Active, not recruiting

Conditions: Dark Spots

Treatments: Other: Retinol serum; Dietary Supplement: oral supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT07477275

UMRAMREC005-24-2

Details and patient eligibility

About

The goal of this study is to evaluate the safety and efficacy of a combination use of oral supplement and topical serum in improving skin pigmentation in healthy women. The main questions it aims to answer are:

Does combination use able to reduce the dark spot? Is there any adverse effect associate with the product use?

Enrollment: 68 estimated patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy Malaysian women.
• Aged 30 - 60 years old.
• Fitzpatrick skin type III-V
• Exhibiting signs of skin pigmentation such as post-inflammatory hyperpigmentation, freckles and solar lentigines.

Exclusion criteria

• Participants with melasma.
• Pregnant, breastfeeding women, or those planning pregnancy during the study period.
• Participants with documented chronic medical conditions such as kidney disease, diabetes, heart problems, liver disease, gastrointestinal disorders, and others.
• Participants with documented autoimmune diseases.
• Participants with inflammatory or allergic skin problems such as atopic dermatitis, rosacea, or psoriasis.
• Use of topical agents for skin brightening within the past three months.
• Consumption of food or supplement products containing L-glutathione, L-cysteine HCL monohydrate, polypodium leucotomos leaf extract, pine bark extract, or other similar supplements, as well as the use of topical products containing niacinamide, glycyrrhiza glabra (licorice) root extract, retinol, or other products for skin brightening or rejuvenation within three months prior to the study.
• Undergoing any cosmetic procedures such as botox, laser and light treatment, facial surgery, or any procedures aimed at improving skin conditions (e.g., skin brightening, elasticity, wrinkles, pores) prior to the study.
• Consumption of any medical or hormonal treatments that could interfere with the study results, such as isotretinoin, tranexamic acid, and others.
• Allergy to any ingredients that may be found in the product.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Oral supplement

Active Comparator group

Description:

Oral supplement contain L-glutathione, L-cysteine HCL monohydrate, polypodium leucotomos leaf extract, and pine bark extract.

Treatment:

Dietary Supplement: oral supplement

Oral supplement + Retinol serum

Active Comparator group

Description:

Oral supplement is the same as the other arm. Topical serum containing niacinamide, glycyrrhiza glabra (licorice) root extract, and retinol.

Treatment:

Dietary Supplement: oral supplement

Other: Retinol serum