None listed
Conditions
Interventions
Intervention1: Marine spicule-based formulation: Topical application of Marine spicule-based skin care formulation
Total duration of study is 3 months
Control Intervention1: NOT APPLICABLE: NOT APPLIC
Sponsors
Dr Madhuri T J
Eligibility
Inclusion criteria
Inclusion criteria: 1. Presence of mild-to-moderate facial fine lines and wrinkles in the prespecified target area 2. Visible mild-to-moderate reduction in facial skin smoothness/texture in the target area, suitable for clinical grading 3. Healthy intact facial skin in the assessment area
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation 2. Severe facial wrinkles or severe photodamage unsuitable for topical cosmetic evaluation 3. Active facial dermatosis, including eczema, dermatitis, psoriasis, active infection, or inflammatory acne in the target area 4. Open wounds, abrasions, sunburn, or broken skin on the face 5. Known hypersensitivity to any component of the study products 6. Significant uncontrolled systemic illness or medical condition that may interfere with study participation 7. Use of topical anti-aging actives, prescription facial products, or medicated cosmetic products on the face within 2 weeks before baseline 8. Chemical peels, facials, microdermabrasion, or similar resurfacing procedures within 4 weeks 9. Botulinum toxin, fillers, microneedling, laser, threads, or energy-based facial procedures within 6 months 10. Participation in another clinical study within the previous 30 days 11. Any other condition that, in the investigator s opinion, makes the participant` unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wrinkle grading scale will be used to evaluate: Crow s Feet Forehead LinesTimepoint: Baseline Day 0, Day 14, Day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in facial skin roughness, texture, and coarseness from baseline to Day 28 Assessment will be done using the Allergan Skin Roughness Scale ASRS.Timepoint: Baseline Day 0, Day 14, Day 28;Investigator assessed overall aesthetic improvement Assessment will be done using the Investigator Global Aesthetic Improvement Scale GAIS.Timepoint: Day 14 and Day 28;Participant perceived improvement in facial skin quality Assessment will be done using a Subject Self Assessment Questionnaire evaluating perceived changes in fine lines and wrinkles, smoothness, softness, hydration, firmness or tightness, and overall skin appearance.Timepoint: Day 14 and Day 28;Standardized photographs will be taken and compared across visits to document visible changes in facial fine lines, wrinkles, texture, and overall appearance.Timepoint: Baseline Day 0, Day 14, Day 28;Safety and tolerability will be assessed by recording local skin reactions including erythema, dryness, scaling, burning or stinging, itching, and any other local cutaneous reaction.Timepoint: Baseline Day 0, Day 14, Day 28 | — |
Countries
India
Contacts
Public ContactMs Kartiki Wani
The Esthetic Clinics (TEC )
Outcome results
None listed