A Clinical Study to Assess the Safety and Effectiveness of Anti-Ageing and Skin Brightening Gel

Study Overview
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Brief Summary
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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 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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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) Visit 02 (Day 30): Treatment Phase (Week 04) Visit 03 (Day 60): End of Study (Week 08) The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent. Subjects will be asked to not wear any makeup on the face on screening day. 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.

Official Title
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A Randomized, Double Blind, Two Arm, Parallel, Placebo-Controlled, Safety and Efficacy Study of Anti-Ageing and Skin Brightening Gel

Conditions
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Wrinkle, Pigment Skin, Aging

Intervention / Treatment
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* Other: Placebo
* Other: Anti-Ageing and Skin Brightening Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a Randomized, Interventional, Prospective, Double Blind, Two Arm, Comparative, Parallel, Placebo-Controlled, Safety and Efficacy Study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Mode of Usage: Twice a day on clean skin Route of Administration: Topical application. | Other: Placebo<br>* Placebo Comparator<br>|
| Experimental: Anti-Ageing and Skin Brightening Gel<br>Mode of Usage: Twice a day on clean skin Route of Administration: Topical application. | Other: Anti-Ageing and Skin Brightening Gel<br>* Anti-Ageing and Skin Brightening Gel.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Skin Elasticity | To assess the effectiveness of the test products in terms of change in Skin Elasticity from before test product usage and after test product usage using Cutometer Dual MPA 580 | From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products | 
| Change in CIE L*, a* b*, ITA (Individual Topography Angle), skin brightness, skin pigmentation | To assess the effectiveness of the test products in terms of change in CIE L*, ITA angle, a* and b* from before test product usage and after test product usage using Skin Colorimeter CL 400. | From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products | 
| Change in Skin Glow | To assess the effectiveness of the test products in terms of change in Skin Glow from before test product usage and after test product usage using Skin Glossymeter GL 200. | From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products | 
| Change in crow's feet area wrinkles, fine lines | To assess the effectiveness of the test products in terms of change in crow's feet area wrinkle, fine line from before test product usage and after test product usage using Visioscan VC 20 | From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products | 
| Change in Skin texture (wrinkles, fine lines, roughness, dryness, wrinkles, and smoothness) of skin | To assess the effectiveness of the test products in terms of change in Skin texture (wrinkles, fine lines, roughness, dryness, wrinkles, and smoothness) of skin from before test product usage and after test product usage using Visioscan VC 20 | From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products | 
| Change in facial photographs | To assess the effectiveness of the test products in terms of change in facial photographs from before test product usage and after test product usage using digital photographs. | From baseline (Day 01) before usage of test products to Day 60 (±2 days) post-usage of test products | 
| Change in wrinkles, fine lines and pores | To assess the effectiveness of the test products in terms of change in wrinkles, fine lines and pores from before test product usage and after test product usage using Image-pro Software. | From baseline (Day 01) before usage of test products to Day 60 (±2 days) post-usage of test products | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physician Global Assessment (PGA) Score | To assess the effectiveness of test treatment in terms of change in PGA scores i.e. dryness, redness, fine lines, coarse wrinkle, laxity, roughness, and sallowness by using Griffith scale Where 0= No appearance and 9= Severe | From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products | 
| Change in Level of skin photodamage | To assess the effectiveness of the test products in terms of change in level of photodamage using Glogau skin age | From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products | 
| Change in skin pigmentation | To assess the effectiveness of the test products in terms of change in skin pigmentation using skin pigmentation scoring. Scoring Scale:(0-absent, 1-mild, 2-moderate, 3-severe) | From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products | 
| Assessment of Consumer Perception | To assess the consumer perception of the test products regarding the test product's effect on skin firmness, appearance, radiance, acne or skin breakouts, glowing skin tone, blemishes and dark skin patches removal using questionnaire. Scoring Scale: (1- strongly disagree, 2-disagree, 3-neither agree nor disagree, 4-agree, 5-strongly agree). | From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products |