None listed
Conditions
Interventions
Intervention1: SPH-24: Oral administration of single dose of SPH-24 once a day for 84 days
Control Intervention1: Placebo: Oral administration of single dose of Placebo once a day for 84 days
Sponsors
Samriddh Nutractive Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects with fine-to-moderate periorbital wrinkles as defined by a score of 4 to 6 on the Fitzpatrick Wrinkle Scale.2.Subjects with Fitzpatrick Skin Type II IV scale.3.Subjects with BMI 18.5-29.9 kg/m2.4.Subjects willing to consent to maintain their regular skincare regimen unaltered during the study period.5.Subjects willing to maintain appropriate sun protection routines.6.Subjects willing to consent to maintain the present diet and/or exercise frequency or intensity without major alterations throughout the study duration.7.Subjects willing to refrain from using any oral products or nutritional supplements aimed at enhancing skin health throughout the trial.8.Subjects willing to refrain from consuming alcohol 24 hours prior to the test days. 9.Subjects willing abstain from ingesting caffeine and caffeine-containing products for 12 hours prior to test days.10.Subjects willing to abstain from intense physical activity for 12 hours before the testing days.11.Subjects willing to provide written consent.
Exclusion criteria
Exclusion criteria: 1.Subjects having hypersensitivity or history of allergy to the study product.2.Women who are pregnant, nursing, or intending to conceive during the study period.3.Subjects with chronic systemic disorders such as cardiovascular, cerebrovascular, liver, and kidney disease.4.Subjects exhibiting uncontrolled hypertension and/or uncontrolled diabetes during the screening process.5.Subjects with skin diseases such psoriasis, eczema, atopic dermatitis, and severe acne.6.Subjects receiving hormonal medicines, medications for obesity, absorption inhibitors, antidepressants, or appetite suppressants.7.Subjects who underwent facial laser therapy, chemical peeling, or experienced UV overexposure within the preceding three months.8.Subjects who cannot avoid prolonged exposure to sunlight.9.Subjects with sleep disturbances and/or are taking sleep aid medication.10.Subjects abstain from consuming additional oral supplements, including antioxidants and dietary supplements.11.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in facial wrinkles assessed in SPH-24 compared to placebo. Timepoint: Day 0, Day 28, Day 56, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in skin firmness assessed in SPH-24 compared to placebo.Timepoint: Day 0, Day 28, Day 56, Day 84;Mean change in skin elasticity assessed in SPH-24 compared to placebo.Timepoint: Day 0, Day 28, Day 56, Day 84;Mean change in overall skin tone assessed in SPH-24 compared to placebo.Timepoint: Day 0, Day 28, Day 56, Day 84;Mean change in skin pigmentation assessed in SPH-24 compared to placebo.Timepoint: Day 0, Day 28, Day 56, Day 84;Mean change in skin erythema assessed in SPH-24 compared to placebo.Timepoint: Day 0, Day 28, Day 56, Day 84;Mean change in skin hydration assessed in SPH-24 compared to placebo.Timepoint: Day 0, Day 28, Day 56, Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd.
Outcome results
None listed