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A study to evaluate the safety and efficacy of a test product in female subjects with varied skin type.

A double-blind, randomized, single centre, two-arm, placebo-controlled, comparative clinical study to evaluate the safety, in-use tolerability and efficacy of Moisturizing Cream in female subjects with varied skin type. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/059282
Enrollment
96
Registered
2023-10-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

None listed

Interventions

Intervention1: Moisturizing Cream: Standard quantity of test product to be applied on cleansed face (using provided face cleanser) using fingertips. Daily application twice a day (morning and evening)

Sponsors

DPKA Universal Consumer Ventures Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Subjects with dry / normal / oily / sensitive skin. o Subjects with self-perceived normal skin. o Subjects with dry (readings between 30 – 40) as assessed by MoistureMeterSC. o Subjects with oily skin having Sebumeter measurement > 150 (µg/cm2). o Subjects with sensitive skin based on Dr. Baumann’s skin type questionnaire. 2) Subjects having good general health as determined by the Investigator on the basis of medical history. 3) Females of Childbearing potential must have a negative urine pregnancy test performed during Visit 01.

Exclusion criteria

Exclusion criteria: 1) Subjects undergoing treatment for skin lightening or subjects using other marketed skin lightening products during the study period or in the past 6 weeks. 2) Subjects who are receiving topical or systemic treatments. 3) Subjects receiving medications (e.g., steroids or antihistamines) would compromise the study. 4) Chronic illness which may influence the cutaneous state. 5) Subjects having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments.

Design outcomes

Primary

MeasureTime frame
Assessment of effectiveness of skin moisturization using MoistureMeterSCTimepoint: Day 01 (Before application, 30 mins, 2 hours, 4 hours post application), Day 08, Day 15, Day 29, Day 31

Secondary

MeasureTime frame
Assessment of Product Response Index (Perception about Product)Timepoint: Day 01 (30 mins post application);Assessment of skin barrier function by measuring Transepidermal Water Loss (TEWL) using VapometerTimepoint: Day 01 (Before application, 30 mins, 2 hours, 4 hours post application), Day 08, Day 15, Day 29, Day 31;Assessment of skin brightness using ChromameterTimepoint: Day 01 (Before application, 30 mins post application), Day 08, Day 15, Day 29, Day 31;Assessment of skin elasticity and firmness using CutometerTimepoint: Day 01 (Before application, 4 hours post application), Day 08, Day 15, Day 29, Day 31;Assessment of skin roughness using 3D Analysis SystemTimepoint: Day 01 (Before application, 30 mins post application), Day 08, Day 15, Day 29, Day 31 ;Assessment of Subject Satisfaction QuestionnaireTimepoint: Day 01 (30 mins, 4 hours post application), Day 08, Day 15, Day 29, Day 31 ;Dermatological assessment of skin dryness using 5-point grading scaleTimepoint: Day 01, Day 08, Day 15, Day 29, Day 31;Dermatological assessment of skin radiance using Modified Griffiths ScaleTimepoint: Day 01, Day 08, Day 15, Day 29, Day 31;Dermatological assessment of skin roughness using 5-point grading scaleTimepoint: Day 01, Day 08, Day 15, Day 29, Day 31

Countries

India

Contacts

Public ContactDr Simran Sethi

Cliantha Research

pjoshi@cliantha.com8000085049

Outcome results

None listed

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