Health Condition 1: L709- Acne, unspecified Health Condition 2: L700- Acne vulgaris
Conditions
Interventions
None listed
Sponsors
Hindustan Unilever Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria will be included in the study. 1) Indian subjects (20% male and 80% female subjects) with mild-to-moderate acne, from more than or equal to 18 years to less than or equal to 40 years of age at the time of consent. 2) Subjects with mild to moderate acne condition (Grade 2 to 3 as per Investigator Global Assessment [IGA] scale). 3) Subjects with normal Fitzpatrick skin type III to VI (human skin color determination scale). 4) Subjects who have been prescribed either the 0.1% thymol + terpineol (Serum) or 0.35% thymol + terpineol (Cleanser) for acne treatment as per the investigator discretion will be invited to participate in the study and provide their data, with no changes to the prescribed treatment. 5) Subjects are able to follow their normal skin routines and refrain from introducing any similar skin care products for acne during the study. 6) Subjects are willing to give written informed consent and are willing to comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1) Subject has a history of allergy or sensitivity to the study product ingredients. 2) Subjects with severe acne conditions, i.e. cysts, and/or nodules, as determined by the investigator/treating doctor. 3) Subjects who have pre-existing or dormant dermatologic conditions (e.g. psoriasis rashes, eczema, seborrheic dermatitis, or any other) that could interfere with the outcome of the study as determined by the investigator. 4) Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks before the start or anticipates having to use at any point during the study. 5) Pregnant or lactating females or planning to become pregnant during the study period. 6) Subjects participating in other similar cosmetics, devices, therapeutic trials, or skin care products within the last 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the acne reduction from baselineTimepoint: Day 1 to days 7, 14, 28, and 56 using the IGA scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Change in post inflammatory hyperpigmentation using PIH scale. 2)Change in post acne hyperpigmentation using PAH scale. 3)Quality of life using the Acne-QoL. 4)Subject perception on study products using the self assessment questionnaire after product application. 5)Change in Subject Response Index after product application.Timepoint: Assessments will be done on Baseline Day 1, Day 7, Day 14, Day 28 and Day 56. | — |
Countries
India
Contacts
Public ContactDr Deepika Mehta
Hindustan Unilever Limited
Outcome results
None listed