A Randomized, Double-blinded, Placebo Controlled, Monocentric Study to Evaluate the Anti-ageing and Skin Brightening Benefit of the Test Product in Healthy Female Subjects

NCT04276753 | Completed

• 1 other identifier: SKIN/SYAS/2020-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Every day the cells of the outer layer of skin die off, shed, and regenerate. When young, skin cells turn over quickly, but that turnover rate begins to slow with age, beginning as early as twenties. As a result, skin loses its luster and begins to look dull. Aging caused by the genes is inherited and is called intrinsic (internal) aging. The other type of aging is known as extrinsic (external) aging and is caused by environmental factors, such as exposure to the sun's rays. Skin ageing is mainly characterized by -

1. 1.Decrease in thickness, firmness \& elasticity of skin which results in wrinkles.
2. 2.Reduction in antioxidant capacities.
3. 3.Formation of spider veins and dark circles under the eyes. This study is proposed to evaluate skin antiaging efficacy along with the brightening attributes on face by visual assessment by Dermatologist, image analysis using VISIA CR, skin elasticity by Cutometer (MPA580) Hydration by Corneometer and skin texture by Antera 3 D and skin lightening/fairness by spectrophotometer, water barrier function by TEWL and to skin pH level by pH meter.

Conditions

Skin Aging

Outcome Measures

Primary Outcomes (2)

• Evaluate the investigational product for skin aging benefits

  Evaluate the antiaging effect of investigational product in 8 weeks w.r.t baseline in comparison to placebo as per below parameters. i. Skin texture ii. Signs of aging iii. Skin elasticity/Firmness iv. Skin wrinkles and expression lines v. Skin dryness

  8 weeks

• Evaluate the investigational product for skin brightening benefits

  Evaluate the skin brightening benefit of investigational product in 8 weeks w.r.t. baseline in comparison to placebo as per below parameters. i. Glow and radiance ii. Evenness iii. Clarity iv. Skin colour

  8 weeks

Secondary Outcomes (1)

• Evaluate the product safety and tolerance by skin tolerance evaluation by dermatologist.

  8 weeks

Study Arms (2)

Terminalia Chebula fruit extract

EXPERIMENTAL

The test product is an emulsion. It contains Terminalia Chebula fruit extract. Test product will be applied topically on full face twice a day for 8 weeks.

Other: Terminalia Chebula Fruit Extract

Placebo

PLACEBO COMPARATOR

The placebo product is an emulsion with same appearance as the experimental product but without Terminalia Chebula fruit extract. Placebo emulsion will be applied topically on full face twice a day for 8 weeks.

Other: Placebo

Interventions

Terminalia Chebula Fruit Extract OTHER

Standardized fruit extract

Terminalia Chebula fruit extract

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 35 Years - 50 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female adult subjects in general good health as determined from a recent medical history, general physical examination, dermatological assessment.
• Subjects in the age group of 35-50 years (both ages inclusive).
• Subject with Fitzpatrick skin types III to V (ITA to be recorded at forehead and flexor forearm)
• Subjects with chronic pollution exposure in past 5 years based on pollution questionnaire (Refer annexure 1)
• Subjects with normal to dry skin type (corneometer reading upto 35)
• Subjects with mild to moderate fine lines and wrinkles in periorbital area (Crow's feet-under eye) \& forehead (Refer annexure 3 for photonumerical scale)
• Subjects with minimum one spot with width ≥3 mm
• Subjects with chronic pollution exposure in past 5 years based on pollution questionnaire (Refer annexure 1)
• Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
• Subject who agrees not to use any other product/treatment/home remedy/ except the provided product on their face during the study period other than the test product.
• Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.
• Subjects who agree not to expose to excessive sun light. (Sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
• Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
• Subjects willing to abide by and comply with the study protocol.

You may not qualify if:

• Subject with any other signs of significant local irritation or skin disease.
• Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.
• Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
• Subjects who do not agree to remove all jewellery on/around face (e.g., necklace, earrings, if possible nose ring), during VISIA imaging.
• Subjects having hair style which covers almost the entire forehead
• Subjects undergoing any treatment of any skin condition on their face/forearm.
• Subjects not willing to discontinue other topical facial products.
• Subject allergic or sensitive to bar cleansing products, cosmetics, creams/lotions, artificial jewellery or anything else.
• Pregnant women (as confirmed by UPT) and lactating women
• Subjects on any medical treatment either systemic/topical in the past 1 month or currently taking medication including food supplements.
• Subjects with skin allergy history or atopic dermatitis or psoriasis
• Subjects who have participated in any other clinical trial in the last 3 months.
• Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study
• Subjects that was treated with Botox/filler /bio stimulatory molecules injection

Sponsors & Collaborators

• Ratan K. Chaudhuri: lead

Study Sites (1)

MSCR

Bengaluru, Karnatka, 560008, India

Location

MeSH Terms

Interventions

chebulae fruit

Study Officials

• Dr Mukesh Ramnane, MD

  MSCR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 19, 2020
• Study Start: September 3, 2020
• Primary Completion: January 20, 2021
• Study Completion: April 30, 2021
• Last Updated: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)