Combination of Oral and Topical Whitening Agents for Reducing Skin Pigmentation

July 29, 2026 updated by: USMARI Research & Innovation Centre

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

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Petaling Jaya, Selangor, Malaysia, 47810
        • USMARI Research & Innovation Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Oral supplement
Oral supplement contain L-glutathione, L-cysteine HCL monohydrate, polypodium leucotomos leaf extract, and pine bark extract.
Dietary supplement: oral 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).
Active Comparator: Oral supplement + Retinol serum
Oral supplement is the same as the other arm. Topical serum containing niacinamide, glycyrrhiza glabra (licorice) root extract, and retinol.
Dietary supplement: oral 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).
Other: Retinol serum
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 6, Week 12
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.
Baseline, Week 6, Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
Week6, Week12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
USMARI Research & Innovation Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UMRAMREC005-24-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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