Status:
COMPLETED
A Clinical Study to Assess the Safety and Effectiveness of Anti-Ageing and Skin Brightening Gel
Lead Sponsor:
NovoBliss Research Pvt Ltd
Collaborating Sponsors:
Green Mountain Biotech Limited
Conditions:
Wrinkle
Pigment Skin
Eligibility:
FEMALE
35-55 years
Phase:
NA
Brief Summary
This is a Randomized, Interventional, Prospective, Double Blind, Two Arm, Comparative, Parallel, Placebo-Controlled, Safety and Efficacy Study of Anti-Ageing and Skin Brightening Gel. Total of 44 adu...
Detailed Description
There will be a total of 3 visits in the study. The subject will be instructed to visit the facility as per the below visits Visit 01 (Day 01): Screening, Enrolment and Treatment Start Phase (Week 00)...
Eligibility Criteria
Inclusion
- Age: 35 to 55 years (both inclusive) at the time of consent.
- Sex: Healthy and non-pregnant/non-lactating females.
- Subjects who are generally in good health as determined by/form recent medical history.
- Female of child bearing capacity must have a self-reported negative pregnancy test.
- Subjects having mild to moderate crows' feet wrinkles.
- Subjects having a score of at least "mild skin aging" based on PGA at screening visit.
- Subjects having a score of at least "mild skin pigmentation" based on Skin Pigmentation Score at screening visit.
- Subjects having Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator.
- Subjects who are willing to forgo cosmetic procedures for the duration of the study.
- Subjects who are able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
- 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.
- Subjects who are willing to give written informed consent and are willing to follow the study procedure.
- 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.
- Subjects who are willing to use test products throughout the study period.
Exclusion
- Subjects having a history of allergy or sensitivity to the test treatments ingredients.
- 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.
- 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.
- 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.
- Subjects not willing to avoid unprotected sun or other UV radiation exposure during the study period.
- Subjects having a history of alcohol or drug addiction.
- 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.
- 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.
- Subjects not willing to avoid unprotected sun or other UV radiation exposure during the study period.
- Subjects who are currently pregnant/breastfeeding or planning to become pregnant during the study period.
Key Trial Info
Start Date :
September 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06123572
Start Date
September 14 2023
End Date
December 9 2023
Last Update
December 12 2023
Active Locations (1)
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1
NovoBliss Research Pvt Ltd
Gandhinagar, Gujarat, India, 382421