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

Completed

• Conditions: Healthy non-pregnant and non-lactating females between age group of 21 to 50 years (both inclusive at the time of consent) with varied skin type

• Registration Number: CTRI/2023/10/059282
• Lead Sponsor: DPKA Universal Consumer Ventures Private Limited

Brief Summary

This is a double-blind, randomized, singlecentre, two-arm, placebo-controlled, comparative clinical study to evaluate thesafety, in-use tolerability and efficacy of a Moisturizing Cream in subjectswith varied skin type.



The potential subjects will be screened as perthe inclusion and exclusion criteria only after obtaining written informedconsent from the subjects.



All eligible subjects will undergo clinicalevaluation by a Dermatologist, instrument evaluation and subjective evaluation. Safetywill be assessed throughout the study by monitoring adverse events.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-30
• Study Completion: 2024-01-01
• Last Update Posted: 2024-02-03

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• 1. Subjects with dry / normal / oily / sensitive skin.
• oSubjects with self-perceived normal skin.
• oSubjects with dry (readings between 30 – 40) as assessed by MoistureMeterSC.
• oSubjects with oily skin having Sebumeter measurement > 150 (μg/cm2).
• oSubjects 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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of effectiveness of skin moisturization using MoistureMeterSC	Day 01 (Before application, 30 mins, 2 hours, 4 hours post application), Day 08, Day 15, Day 29, Day 31

Secondary Outcome Measures

Name	Time	Method
Dermatological assessment of skin dryness using 5-point grading scale	Day 01, Day 08, Day 15, Day 29, Day 31
Dermatological assessment of skin radiance using Modified Griffiths Scale	Day 01, Day 08, Day 15, Day 29, Day 31
Dermatological assessment of skin roughness using 5-point grading scale	Day 01, Day 08, Day 15, Day 29, Day 31
Assessment of skin barrier function by measuring Transepidermal Water Loss (TEWL) using Vapometer	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 Chromameter	Day 01 (Before application, 30 mins post application), Day 08, Day 15, Day 29, Day 31
Assessment of skin elasticity and firmness using Cutometer	Day 01 (Before application, 4 hours post application), Day 08, Day 15, Day 29, Day 31
Assessment of skin roughness using 3D Analysis System	Day 01 (Before application, 30 mins post application), Day 08, Day 15, Day 29, Day 31
Assessment of Subject Satisfaction Questionnaire	Day 01 (30 mins, 4 hours post application), Day 08, Day 15, Day 29, Day 31
Assessment of Product Response Index (Perception about Product)	Day 01 (30 mins post application)

Trial Locations

Locations (1)

Cliantha Research; 🇮🇳 Ahmadabad, GUJARAT, India

Cliantha Research

🇮🇳Ahmadabad, GUJARAT, India

Dr Bhagirath Patel

Principal investigator

07966135601

bhagirathrpatel1818@gmail.com