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A study to evaluate efficacy and safety of 4 test products on subjects with mild to moderate acne.

To assess the effectiveness of Topical Formulae for their efficacy on skin acne related imperfections through instrumental and dermatologist assessment on mild to moderate acne over 4-week daily 2X usage in healthy adult subjects. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079305
Enrollment
184
Registered
2025-01-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

None listed

Interventions

Intervention1: Face Cleanser: Cleansing face with standard cleanser. 1 ml of test product will be used as cleanser twice a day starting from Day 01 to Day 28. Application of neutral moisturizer post

Sponsors

LOréal India Pvt. Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Subjects with skin phototype III - V (Fitzpatrick phototype assessed based on ITA value) 2) Subjects having Body Mass Index in the range of 18 to 25 kg/m2. 3) Subjects having oily skin type and combination of oily, sensitive. 4) Subjects with mild to moderate acne severity based on IGA scale. 5) Subjects with PIH spot of 3mm & above. 6) Subjects presenting acne lesions count: • more than/equal to 10 to less than/equal to 25 inflammatory acne lesions on whole face • more than 25 to less than/equal to 100 non-inflammatory acne lesions on whole face

Exclusion criteria

Exclusion criteria: 1) Subjects who have used anti acne products in the last 30 days. 2) Subjects who are receiving topical or systemic treatments for acne and PIH within last 30 days. 3) Subjects undergoing dermatological procedures for skin lightening or using other marketed skin lightening products during the study period or in the past 6 weeks. 4) Subjects having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments. 5) Subject having excessive hair, moles, open wounds, cuts, abrasions, irritation symptoms, tattoos, scars, sunburn or any dermatological condition on the test site(s) that can interfere with the reading.

Design outcomes

Primary

MeasureTime frame
1) Dermatological assessment of acne lesions using counting method. 2) Instrumental assessment of intensity of PIH and bare skin. 3) Instrumental assessment of the size of PIHTimepoint: Screening Visit, Day 01, Day 03, Day 07, Day 14, Day 28 and Day 42.

Secondary

MeasureTime frame
Dermatological assessment of Acne Severity using grading scaleTimepoint: Screening Visit, Day 01, Day 03, Day 07, Day 14, Day 28 and Day 42.;Dermatological assessment of Redness around Acne lesion and skin radiance using grading scaleTimepoint: Day 01, Day 03, Day 07, Day 14, Day 28 and Day 42;Instrumental assessment of skin sebum level, face hydration, skin barrier function and skin brighteningTimepoint: Day 01, Day 03, Day 07, Day 14, Day 28 and Day 42;Instrumental assessment of Redness around acne (a value & redness measurements), acne elevation & sebaceous poresTimepoint: Screening Visit, Day 01, Day 03, Day 07, Day 14, Day 28 & Day 42.;Dermatological assessment of global efficacy and tolerance of productsTimepoint: Day 03, Day 07, Day 14, Day 28 and Day 42.;Subjective assessmentTimepoint: Day 01, Day 03, Day 07, Day 14, Day 28 and Day 42.

Countries

India

Contacts

Public ContactDr Parth Joshi

Cliantha Research

ssethi@cliantha.com9825784942

Outcome results

None listed

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