CTRI/2023/09/057287
Completed
未知
A Randomized, Double Blind, Two Arm, Parallel, Placebo-Controlled, Safety and Efficacy Study of Anti-Ageing and Skin Brightening Gel. - NI
Green Mountain Biotech Limited0 sites44 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Green Mountain Biotech Limited
- Enrollment
- 44
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Age: 35 to 55 years (both inclusive) at the time of consent.
- •2\) Sex: Healthy and non\-pregnant/non\-lactating females.
- •3\) Subjects who are generally in good health as determined by/form recent medical history.
- •4\) Female of child bearing capacity must have a self\-reported negative pregnancy test.
- •5\) Subjects having mild to moderate crows’ feet wrinkles.
- •6\) Subjects having a score of at least mild skin aging ? based on PGA at screening visit.
- •7\) Subjects having a score of at least mild skin pigmentation ? based on Skin Pigmentation Score at screening visit.
- •8\) Subjects having Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator.
- •9\) Subjects who are willing to forgo cosmetic procedures for the duration of the study.
- •10\) Subjects who are able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
Exclusion Criteria
- •1\) Subjects having a history of allergy or sensitivity to the test treatments ingredients.
- •2\) Subjects who have pre\-existing or dormant dermatologic conditions (e.g., psoriasis rashes, eczema, seborrheic dermatitis, acne or any other) that could interfere with the outcome of the study as determined by the Investigator.
- •3\) Subjects who have used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
- •4\) Subjects who have applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
- •5\) Subjects not willing to avoid unprotected sun or other UV radiation exposure during the study period.
- •6\) Subjects having a history of alcohol or drug addiction.
- •7\) Subjects who have used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
- •8\) Subjects who have applied any topical retinoids or glutathione within 2 weeks of the screening visit or anticipates having to use at any point during the study.
- •9\) Subjects not willing to avoid unprotected sun or other UV radiation exposure during the study period.
- •10\) Subjects who are currently pregnant/breastfeeding or planning to become pregnant during the study period.
Outcomes
Primary Outcomes
Not specified
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