Clinical trial NCT06123572: A Clinical Study to Assess the Safety and Effectiveness of Anti-Ageing and Skin Brightening Gel
Official title: A Randomized, Double Blind, Two Arm, Parallel, Placebo-Controlled, Safety and Efficacy Study of Anti-Ageing and Skin Brightening Gel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Pigment Skin
Aging
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
Collaborators: name: Green Mountain Biotech Limited
First posted: 2023-11-09
Enrollment: 44
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Randomized, Interventional, Prospective, Double Blind, Two Arm, Comparative, Parallel, Placebo-Controlled, Safety and Efficacy Study
Primary purpose: TREATMENT

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)

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) 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Change in Skin Elasticity
timeFrame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
measure: Change in CIE L*, a* b*, ITA (Individual Topography Angle), skin brightness, skin pigmentation
timeFrame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
measure: Change in Skin Glow
timeFrame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
measure: Change in crow's feet area wrinkles, fine lines
timeFrame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
measure: Change in Skin texture (wrinkles, fine lines, roughness, dryness, wrinkles, and smoothness) of skin
timeFrame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
measure: Change in facial photographs
timeFrame: From baseline (Day 01) before usage of test products to Day 60 (±2 days) post-usage of test products
measure: Change in wrinkles, fine lines and pores
timeFrame: From baseline (Day 01) before usage of test products to Day 60 (±2 days) post-usage of test products
Secondary outcomes:
measure: Change in Physician Global Assessment (PGA) Score
timeFrame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
measure: Change in Level of skin photodamage
timeFrame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
measure: Change in skin pigmentation
timeFrame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
measure: Assessment of Consumer Perception
timeFrame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
Other outcomes:
Locations:
city: Gandhinagar
country: India
facility: NovoBliss Research Pvt Ltd
state: Gujarat
Study officials:
affiliation: NovoBliss Research Private Limited
name: Dr Nayan K Patel
role: PRINCIPAL_INVESTIGATOR
References: