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NCT Number: NCT07477275

Combination of Oral and Topical Whitening Agents for Reducing Skin Pigmentation

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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Dark Spots

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

USMARI Research & Innovation Centre

Petaling Jaya, Selangor, 47810, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral Supplement

Dietary Supplement

Oral supplement need to be consume for 12 weeks. Subject need to consume the capsule once daily, during the first week. After the first week, if there are no adverse effects, they need to consume the capsule twice daily (normal dosage).

Retinol serum

Other

Serum need to be apply daily at night only, in a thin layer. The application schedule is as follows: in week 1, once a week; in week 2, twice a week (if no adverse reactions occur in week 1, such as skin dryness); in weeks 3 and 4, twice a week; and from week 4 onwards until the study is completed, three times per week.

Primary outcomes

  1. Skin spots assessment

    Time frame: Baseline, Week 6, Week 12

    Changes in skin spots (assessed under polarized and UV light) are evaluated using the JANUS III Facial Skin Analysis System.

  2. Skin brightening assessment

    Time frame: Baseline, Week 6, Week 12

    Changes in skin brightness (L value) are evaluated using the JANUS III Facial Skin Analysis System.

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: 12 weeks

    The safety of the oral supplement and topical products will be evaluated throughout the study by monitoring adverse events (AEs) such as gastrointestinal discomfort, body skin tingling, itching, stinging sensation, erythema or obvious signs of dry skin, desquamation, flushing and other symptoms reported by the participants.

  2. Participants satisfaction

    Time frame: Week6, Week12

    Participants' satisfaction with regards to skin brightness, spots, wrinkles, and pores will be assessed through a survey. Participants will answer questions about their preferences using a 5-point scale: 5 - Strongly Agree, 4 - Agree, 3 - Neutral, 2 - Disagree, and 1 - Strongly Disagree.

Sponsors and collaborators

Lead sponsor

USMARI Research & Innovation Centre

Industry

Registry information

Official study title

Combination of Oral and Topical Whitening Agents for Reducing Skin Pigmentation in Healthy Women: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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