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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral supplement | Active Comparator | Oral supplement contain L-glutathione, L-cysteine HCL monohydrate, polypodium leucotomos leaf extract, and pine bark extract. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USMARI Research & Innovation Centre | Petaling Jaya | Selangor | 47810 | Malaysia |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| 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. |
|
| 12 weeks |
| Participants satisfaction | 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 |