A study to evaluate the Effectiveness of a Moisturizer on Skin Moisturization.

Completed

Conditions: Adult subjects of both sex (preferably with equal numbers) with age between 18 and 35 years (both inclusive at the time of consent) having acne-prone skin and with mild to moderate acne.

Registration Number: CTRI/2022/09/045434

Lead Sponsor: Dr Reddys Laboratories Ltd

Brief Summary: This is an openlabel, single-arm, clinical study to evaluate the effecttiveness of a Moisturizer on skin moisturization in adultsubjects with mild to moderate acne.

The potentialsubjects will be screened as per the inclusion and exclusion criteria onlyafter obtaining written informed consent from the subjects.

There are total6 visits in the study i.e.,

Visit 01: Screening Visit (Within 30 Days Prior to Day 1)

Visit 02: Enrollment (Day 01)

Visit 03: Evaluation Phase (Day 15 Â± 02 Days)

Visit 04: Evaluation Phase (Day 30 Â± 02 Days)

Visit 05: Evaluation Phase (Day 45 Â± 02 Days)

Visit 06: Evaluation Phase and End of Study (Day 60 Â± 02Days)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 36

Inclusion Criteria

1.Age: 18 to 35 years (both inclusive) at the time of consent.
2.Sex: Adult male and non-pregnant/non-lactating female.
3.Subjects with acne-prone skin and with mild to moderate acne condition as per IGA scale for Acne severity.
4.Subjects with oily skin having Sebumeter measurement > 180 (Âµg/cm2).
5.Subjects with acne marks/spots and visible pores.

Exclusion Criteria

1.Subjects with drug induced acne as disclosed by subjects.
2.Subjects undergoing treatment for skin lightening.
3.Subjects who are receiving topical or systemic treatments.
4.Subjects with any pigmentary disorder including freckles and melasma.
5.Subjects using other marketed skin lightening products during the study period or in the past 6 weeks.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of test product in improving the skin moisturization using CorneometerÂ® CM 825 / MoistureMeterSC	Day 01 (before application) and Day 15 (plus minus 2 days)

Secondary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of test product in improving the skin moisturization using CorneometerÂ® CM 825 / MoistureMeterSC	Day 01 (before application), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days)
To evaluate the effectiveness of test product in preventing the appearance of new acne by using Investigatorâ€™s Global Assessment (IGA) Scale for Acne Vulgaris	Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days)
To evaluate the effectiveness of test product in reducing skin redness using 5-point scale by Dermatologist	Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days)
To evaluate the effectiveness of test product in Restoring/ Improving the skin barrier function by measuring Transepidermal Water Loss (TEWL) using TEWAmeterÂ® TM300 / Vapometer	Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days)
To evaluate the effectiveness of test product on reduction of skin sebum level using SebumeterÂ® SM 815	Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days)
To assess the Subject Satisfaction Questionnaire after product usage	Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days)
To evaluate the effectiveness of test product on acne reduction by using Investigatorâ€™s Global Assessment (IGA) Scale for Acne Vulgaris	Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days)
To evaluate the effectiveness of test product on acne using 3D analysis system	Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days)
To evaluate Subject Response Index (Perception about Product) after product usage	Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days)
Exploratory Endpoints:	10.1 To evaluate the effectiveness of test product in reducing skin pigment using 9-point scale by Dermatologist.

Trial Locations

Locations (1): Cliantha Research
🇮🇳
Ahmadabad, GUJARAT, India
Cliantha Research
🇮🇳Ahmadabad, GUJARAT, India
Dr Parth Joshi
Principal investigator
8000085049
pjoshi@cliantha.com