None listed
Conditions
Interventions
Intervention1: Liposomal Glutathione (LipogloTM): Each capsule contains 500 mg liposomal glutathione (LipogloTM), administered orally once daily after a meal for 84 days.
Control Intervention1: Non-Li
Sponsors
Botanic Healthcare Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy individuals who are able to understand all the information provided and who give written informed consent. 2. The study will include healthy participants aged between 20 and 50 years. 3. Eligible subjects will have skin types IV or V according to the Fitzpatrick scale. 4. Participants engaged in indoor office-based occupations for at least 8 hours per day 5. Subject with facial melanin index ranging between 200 and 350 will be included in the study. 6. Non-smoker participants included in the study 7. All participants will be confirmed to be in good health based on medical history, physical examination, and clinical laboratory evaluations, including serological, haematological, and biochemical assessments.
Exclusion criteria
Exclusion criteria: 1. History of skin cancer in the participant or close family members, particularly melanoma. 2. Use of oral glutathione supplements within one month before study enrolment 3. Use of topical skin-brightening or whitening products within one month before enrolment 4. Presence of skin conditions or pigmentation disorders that may affect study assessments 5. Pregnant or breastfeeding women 6. History of allergy or hypersensitivity to oral medications 7. Presence of any major medical illness that may interfere with study participation 8. Abnormal liver function test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in skin pigmentation measured by facial melanin level using MexameterTimepoint: Baseline, week 2, week 4, week 8 and week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the change in skin colour parameters, including pigmentation and erythema using a Mexameter.Timepoint: Baseline, week 2, week 4, week 8 and week 12.;To assess changes in facial skin texture and appearance, including UV spots, pore characteristics, skin evenness, wrinkles, smoothness, and scaliness, using blinded dermatologist evaluation using subjective assessment and standardized facial photography along with ImageJ analysis.Timepoint: Baseline, week 2, week 4, week 8 and week 12.;To evaluate changes in skin barrier function measure using TEWL via Tewameter.Timepoint: Baseline, week 2, week 4, week 8 and week 12.;To assess changes in skin hydration using the CorneometerTimepoint: Baseline, week 2, week 4, week 8 and week 12.;To assess skin firmness and elasticity using the CutometerTimepoint: Baseline, week 2, week 4, week 8 and week 12.;To assess subjective changes in skin properties, as reported by participants using a 4-point rating scale.Timepoint: Baseline, week 2, week 4, week 8 and week 12.;To evaluate changes in systemic glutathione status, including plasma reduced glutathione(GSH) and oxidized/protein-bound glutathione (GSSG and GSSP) levels, measured using a validated LC-MS method.Timepoint: Baseline and week 12 | — |
Countries
India
Contacts
Public ContactDr H N Shivaprasad
Botanic Healthcare Pvt. Ltd.
Outcome results
None listed