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

NCT06123572 | Completed

• 1 other identifier: NB230027-GB
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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 adult female subjects (22 Subjects/Arm) of age 35 - 55 years will be enrolled to get 40 completed subjects (20 Subjects/Arm)

Conditions

Wrinkle; Pigment Skin; Aging

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Change in Physician Global Assessment (PGA) Score

  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

  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

  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

  From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Mode of Usage: Twice a day on clean skin Route of Administration: Topical application.

Other: Placebo

Anti-Ageing and Skin Brightening Gel

EXPERIMENTAL

Mode of Usage: Twice a day on clean skin Route of Administration: Topical application.

Other: Anti-Ageing and Skin Brightening Gel

Interventions

Placebo OTHER

Placebo Comparator

Placebo

Anti-Ageing and Skin Brightening Gel OTHER

Anti-Ageing and Skin Brightening Gel.

Anti-Ageing and Skin Brightening Gel

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Green Mountain Biotech Limited: collaborator

Study Sites (1)

NovoBliss Research Pvt Ltd

Gandhinagar, Gujarat, 382421, India

Location

MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Nayan K Patel

  NovoBliss Research Private Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects will be randomly assigned in as 1:1 ratio to receive either test product A or B.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator-Medical Director

Model Details: This is a Randomized, Interventional, Prospective, Double Blind, Two Arm, Comparative, Parallel, Placebo-Controlled, Safety and Efficacy Study

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 9, 2023
• Study Start: September 14, 2023
• Primary Completion: November 20, 2023
• Study Completion: December 9, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)