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A clinical study to determine the safety, tolerability and effectiveness of Day Cream, Night Cream, Serum and Anti-Aging Cream in healthy adult subjects

A clinical study to assess moisture kinetics, brightness and anti-ageing related benefits, safety, efficacy and in-use tolerability of Day Cream, Night Cream, Skin Serum and Anti-Aging Cream - Nil

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058750
Enrollment
120
Registered
2023-10-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Anti-Aging Cream: Mode of Usage: Wash your face with given standard facewash and take pea size, apply on the face and massage well before going to bed at night. Frequency: Once a Day (N

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age: 30 - 55 above (both inclusive) old at the time of consent. 2) Sex: Healthy non-pregnant/non-lactating females. 3) Females of childbearing potential must have a self-reported negative urine pregnancy test. 4) Subjects are generally in good general health as determined from recent medical history. 5)Subjects forearm must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tan, excessive hair or open wounds on or near the test sites. 6) Subjects with mild to moderate age spots, sun spots, dark spots. 7) The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits. 8) The subject must be able to understand and provide written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1) Subject with known allergy or sensitization to product ingredients. 2) Subjects with very severe persistent spots. 3) The subject has clinically significant skin disease, which may contraindicate participation, including psoriasis, eczema, Skin cancer or other skin pathology. 4)The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the face that can interfere with the reading. 5)Be wearing any facial makeup, including false eyelashes, on the day of the study visit 6)Subject participation in the study involving the only one application of a personal care product such as lotion or cleansing product to the test area with no invasive procedure within the four weeks prior to enrolment. 7)Medication which may affect skin response and/or past medical history. 8)Topical drugs used at the application site. 9)An individual who has a medical condition or is taking or has taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk. 10)Subjects who have been treated with systemic retinoids or steroids within the past month prior to entry to the study. 11)Subjects who have been treated with topical steroids, retinoids or other topical drugs within 2 weeks prior to entry to the study. 12)Participation in other clinical studies simultaneously.

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness of the test product in terms of 1) Change in skin hydration. 2) Change in L, a, b and ITA value. 3) Change in sun spot, dark spot, or pigmentation (melanin) and erythema. 4) Change in trans epidermal water loss 5) Change in topography – crow’s feet area wrinkles, fine lines, roughness, smoothness, scaliness, and dryness on face. 6) Change in skin glow and radiance. 7) Change in skin elasticity. 8) Change in 72 hrs moisturization for skin hydration 9) Change in rapid skin turnover 10) 20 layer deep penetration of test productsTimepoint: from baseline before and after usage of test product at T15min on Day 01,24 hours, 48 hours, 72 hours, Day 30 and Day 60

Secondary

MeasureTime frame
To assess the absorption of test product by using tissue absorbent testTimepoint: After 10 seconds of usage of test product at T0 (10 seconds);To evaluate the product effectiveness in terms of subject response indexTimepoint: From before usage of the test product on day 01 and after usage of the test product on Day 07 Day 14 Day 30, Day 60;To evaluate the safety of the test product in terms of change in Visual evaluation at application sites in terms of signs of erythema, dryness.Timepoint: from baseline (before product usage) and after product usage T15min on Day 01, Day 7, Day 14 Day 30 Day 60

Countries

India

Contacts

Public ContactMaheshvari Patel

NovoBliss Research Private Limited

dr.nayan@novobliss.in9909013286

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026