A clinical study to check the safety and effectiveness of Anti-Ageing and skin brightening gel in healthy adult female subjects.
- Registration Number
- CTRI/2023/09/057287
- Lead Sponsor
- Green Mountain Biotech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 44
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.
11) Subjects who are willing not to introduce any new soaps, cleansers, lotions, creams, or any other face products etc. for the duration of the study.
12) Subjects who are willing to give written informed consent and are willing to follow the study procedure.
13) Subjects who commit not to use medicated/ prescription anti-ageing and skin brightening products or any other anti-ageing and skin brightening products other than the test products for the entire duration of the study.
14) Subjects who are willing to use test products throughout the study period.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method