Dark Spots
Conditions
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?
Interventions
OTHERRetinol 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.
DIETARY_SUPPLEMENToral 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).
Sponsors
USMARI Research & Innovation Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin spots assessment | 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. |
| Skin brightening assessment | Baseline, Week 6, Week 12 | Changes in skin brightness (L value) are evaluated using the JANUS III Facial Skin Analysis System. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 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. |
| Participants satisfaction | 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. |
Countries
Malaysia
Outcome results
None listed