A Clinical Study to Assess the Safety and Effectiveness of Anti-Ageing and Skin Brightening Gel
NCT ID: NCT06123572
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2023-09-14
2023-12-09
Brief Summary
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Total of 44 adult female subjects (22 Subjects/Arm) of age 35 - 55 years will be enrolled to get 40 completed subjects (20 Subjects/Arm)
Detailed Description
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Assessment of efficacy parameters before test products usage will be done on Day 01 after enrolment and after test products usage will be done on Day 30 (± 2 days) and Day 60 (± 2 days) as listed-below.
* PGA scoring using Griffiths scale - skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness.
* Glogau skin age.
* Skin pigmentation scoring.
* Skin elasticity: Cutometer Dual MPA 580.
* Skin colorimeter CL 400: CIE L\*, a\* b\*, ITA angle, skin brightness, skin pigmentation reduction.
* Skin Glossymeter GL200 - skin glow.
* Visioscan (C+K instrument): crow's feet area wrinkles, fine lines, skin texture - roughness, dryness, wrinkles, smoothness.
* Digital photographs: facial photographs before test products usage on day 1 and post-usage at day 60.
* Image-pro software - image analysis day 01 vs day 60 - wrinkles, fine lines, pores.
* Subjective product perception assessment regarding the test product's effect on skin firmness, appearance, radiance, acne or skin breakouts, glowing skin tone, blemishes and dark skin patches removal etc.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Mode of Usage: Twice a day on clean skin Route of Administration: Topical application.
Placebo
Placebo Comparator
Anti-Ageing and Skin Brightening Gel
Mode of Usage: Twice a day on clean skin Route of Administration: Topical application.
Anti-Ageing and Skin Brightening Gel
Anti-Ageing and Skin Brightening Gel.
Interventions
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Placebo
Placebo Comparator
Anti-Ageing and Skin Brightening Gel
Anti-Ageing and Skin Brightening Gel.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
35 Years
55 Years
FEMALE
Yes
Sponsors
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Green Mountain Biotech Limited
UNKNOWN
NovoBliss Research Pvt Ltd
OTHER
Responsible Party
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Dr Nayan Patel
Principal Investigator-Medical Director
Principal Investigators
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Dr Nayan K Patel
Role: PRINCIPAL_INVESTIGATOR
NovoBliss Research Private Limited
Locations
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NovoBliss Research Pvt Ltd
Gandhinagar, Gujarat, India
Countries
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Other Identifiers
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NB230027-GB
Identifier Type: -
Identifier Source: org_study_id