None listed
Conditions
Interventions
None listed
Sponsors
Ms Ozone Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Volunteers meeting the following criteria will be enrolled: ïâ??· Between the age of 18-65 years; ïâ??· Available for 3 study visits; ïâ??· Fine lines/wrinkles: Allergen fine lines (ââ?°Â¥ grade 1) ïâ??· Individuals who are willing to provide written informed consent ïâ??· Individuals willing not to wear makeup or use skin care products other than the study products the day of the study visits; ïâ??· Individuals willing to discontinue using current skincare products and only use study products for the study duration. ïâ??· Individuals willing to refrain from sun tanning / sun bathing for the study duration
Exclusion criteria
Exclusion criteria: Volunteers will be excluded from the study if they meet any of the criteria listed below: ïâ??· Any medically diagnosed chronic skin problems on their face (e.g., psoriasis, eczema, seborrheic dermatitis, or chronic cystic acne, etc.) ïâ??· Diagnosed with known allergies to facial skin care products ïâ??· Have undergone dermatological skin rejuvenation procedures such as light-therapies (lasers, radiofrequency and other lights treatments ) or such as collagen or other facial tissue augmentation, fillers, or retail micro dermabrasion on the face within the last 1 year preceding the baseline visit and intended to receive them during the study period ïâ??· Have planned surgeries or invasive procedures during the course of the study. ïâ??· Excessively tanned face before the baseline visit and who intend to excessively be exposed to sun. ïâ??· Have sunburned skin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Endpoints ïâ??· Reduction of fine lines according to Allergan Fine Lines Scale (Grade 0 to 4) ïâ??· Subjective Improvement in fine lines, skin whitening and skin smoothening scoring Timepoint: baseline, 4 weeks and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety/Tolerability Endpoints ïâ??· No visible Erythema, oedema, , scaling, dryness, burning, tingling stinging & itching ïâ??· Monitoring of adverse events throughout the course of the study. Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactSumit Nathani
National Institute of Ayurveda
Outcome results
None listed