NCT07477275

Brief Summary

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?

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

March 4, 2026

Last Update Submit

March 12, 2026

Conditions

Dark Spots

Outcome Measures

Primary Outcomes (2)

  • Skin spots assessment

    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

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

    Baseline, Week 6, Week 12

Secondary Outcomes (2)

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

    12 weeks

  • Participants satisfaction

    Week6, Week12

Study Arms (2)

Oral supplement

ACTIVE COMPARATOR

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

Dietary Supplement: oral supplement

Oral supplement + Retinol serum

ACTIVE COMPARATOR

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

Dietary Supplement: oral supplementOther: Retinol serum

Interventions

oral supplementDIETARY_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).

Oral supplementOral supplement + Retinol serum
Retinol serumOTHER

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.

Oral supplement + Retinol serum

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USMARI Research & Innovation Centre

Petaling Jaya, Selangor, 47810, Malaysia

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 17, 2026

Study Start

December 1, 2024

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)