Oral Glutathione As A Skin Whitening Agent
- Conditions
- GlutathioneSkin Whitening
- Interventions
- Drug: Placebo oral tablet
- Registration Number
- NCT04105504
- Lead Sponsor
- Dr Irma Bernadette S Sitohang
- Brief Summary
The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12 weeks, used as a skin-whitening agent. The study was a randomized, double-blind, placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army Hospital Jakarta, Dr. dr. Wahiddin Soedirohoesodo Hospital Makassar, and University of Sumatera Utara Teaching Hospital Medan. Ninety healthy females, aged between 33 and 50 years, were randomized to receive either glutathione capsules or placebo for 12 weeks and evaluated every 4 weeks. The main outcome was total reduction (improvement) of spot UV, spot polarization, and skin tone measured at five different sites for each indices, recorded by Janus Facial Analysis System®.
- Detailed Description
The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12 weeks, used as a skin-whitening agent.
The study was a randomized, double-blind, placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army Hospital Jakarta, Dr. dr. Wahiddin Soedirohoesodo Hospital Makassar, and University of Sumatera Utara Teaching Hospital Medan.
Ninety healthy females, aged between 33 and 50 years, were randomized to receive either glutathione capsules (500 mg) or placebo capsules, which were identical in appearance and packaged in identical-looking containers. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks. Compliance was assessed by counting the remaining capsules at each follow-up visit.
At each follow-up visit, subjects were asked to grade the overall response and questioned regarding adverse events. The objective or main outcome was total reduction (improvement) of spot UV, spot polarization, and skin tone measured at five different sites for each indices, recorded by Janus Facial Analysis System®.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 90
- Healthy subjects with skin type Fitzpatrick IV and V
- Women aged from 30 to 55 years with an understanding of all the information given by a written consent form
- Working indoor office jobs (for minimum 8 hours)
- Personal or family history of skin cancer, especially melanoma
- Consumption of any preparations containing glutathione within 1 month of enrollment
- Use of any topical skin brightening or whitening preparations within 1 month of enrollment
- Pigmentary disorders or any dermatoses, which may affect the measurement within the study areas
- A pregnant or breastfeeding mother
- Personal history of drug allergy or skin disorder due to side effects of oral therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Group Placebo oral tablet Subjects were randomised to receive Placebo capsules, which were identical in appearance and packaged in identical-looking containers with the Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks. Glutathione Group Glutathione Subjects were randomised to receive Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks.
- Primary Outcome Measures
Name Time Method Change from Baseline Spot UV at 4 weeks 4 weeks Total reduction (improvement) of spot UV
Change from Baseline Spot UV at 8 weeks 8 weeks Total reduction (improvement) of spot UV
Change from Baseline Spot Polarization at 4 weeks 4 weeks Total reduction (improvement) of spot polarization
Change from Baseline Skin Tone at 12 weeks 12 weeks Improvement of skin tone
Change from Baseline Spot Polarization at 8 weeks 8 weeks Total reduction (improvement) of spot polarization
Change from Baseline Skin Tone at 4 weeks 4 weeks Improvement of skin tone
Change from Baseline Skin Tone at 8 weeks 8 weeks Improvement of skin tone
Change from Baseline Spot UV at 12 weeks 12 weeks Total reduction (improvement) of spot UV
Change from Baseline Spot Polarization at 12 weeks 12 weeks Total reduction (improvement) of spot polarization
- Secondary Outcome Measures
Name Time Method Subjective Improvement at 4 weeks 4 weeks Subjects were asked to grade the overall response using rating scale with a multiple-choice question:
1. minimal improvement
2. moderate improvement
3. good improvement
4. excellent improvement
Note: The higher improvement represents a better outcome.Adverse events at 4 weeks 4 weeks Adverse events related to therapy
Subjective Improvement at 8 weeks 8 weeks Subjects were asked to grade the overall response using rating scale with a multiple-choice question:
1. minimal improvement
2. moderate improvement
3. good improvement
4. excellent improvement
Note: The higher improvement represents a better outcome.Adverse events at 8 weeks 8 weeks Adverse events related to therapy
Subjective Improvement at 12 weeks 12 weeks Subjects were asked to grade the overall response using rating scale with a multiple-choice question:
1. minimal improvement
2. moderate improvement
3. good improvement
4. excellent improvement
Note: The higher improvement represents a better outcome.Adverse events at 12 weeks 12 weeks Adverse events related to therapy
Trial Locations
- Locations (1)
Faculty of Medicine, Universitas Indonesia
🇮🇩Jakarta Pusat, Indonesia
Faculty of Medicine, Universitas Indonesia🇮🇩Jakarta Pusat, Indonesia