None listed
Conditions
Interventions
Intervention1: Saslic Foaming Facewash: Saslic Facewash would be administered to subjects who have oily skin texture and acne prone skin.
Intervention2: Saslic Foaming Facewash: The safety and efficac
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Healthy female and male subjects aged 18 - 35 years. 2. Skin phototype IV -V (Fitzpatrick). 3. Subjects having oily skin type and acne prone skin, according to the Investigator. 4. Subjects presenting with mild (grade 2) to moderate acne (grade 3) severity on an IGA scale from 0 to 4, according to the investigator. 5. Subject presenting acne lesions count: • = 10 to = 20 inflammatory acne lesions on whole face. • =25 or = 100 non-inflammatory acne lesions on whole face. 6. Subjects presenting with sebum casual levels (SCL) on forehead > 80 µg/cm2 (mean). 7. Willing not to go for U.V. sessions/sun tanning/sun-bathing during the study duration.Subjects agreeing to use only the provided investigational product during the study. 9. Subjects informed about the study objectives and procedures, and able to understand them. 10. Subject willing and able to fulfill the study requirements and schedule. 11. Subject willing to provide written informed consent and are able to understand English or Hindi. 12. Male subjects willing to use razor/trimmer at least 24 hours before the visit and not to shave in opposite direction throughout the study duration (Preferably, use trimmer to trim the moustache and beard, if possible). 13. Subjects willing to avoid oily, greasy, junk food and high sugar food items, as much as possible during the study period. 14. Subjects willing not to apply hair oil and wash their hair within 48 hours prior to the visit.
Exclusion criteria
Exclusion criteria: 1. Subjects who are pregnant or lactating or who are planning to become pregnant during the study. 2. Subjects who have started, stopped or changed his/her hormonal treatment (including contraceptive pill) in the previous one month prior to the study. 3. History of allergies, hypersensitivity or any serious reactions to any ingredients of the investigational products. 4. Any significant skin pathology in the test area (face), like rosacea, severe acne, eczema, and other. 5. Any significant medical condition that would interfere with the participation in the study, as per opinion of the Investigator. 6. Any concomitant medical/surgical condition or using medication which may harm the subject or may interfere with the study assessments, as per opinion of the Investigator. 7. Any topical or systemic treatment that could interfere with the study treatments/assessments (topical benzoyl peroxide and other antiacne or antiseborreic products, antibiotics, corticosteroids, retinoids, anti-inflammatory drugs) within the last 4weeks prior to participation in the study, and during the study. 8. Any dermatological procedure on the face (laser peel, dermabrasion etc.) taken 4 weeks before the start of the study and during the study. 9. Subject reported or planning to sun-bathe or to overexpose to UV-light (mountains sports, phototherapy, tanning salon use) for aesthetic or therapeutic reason the month before the study start or during the study. 10. Having participated in the last 30 days before screening or currently participating in another clinical study. 11. Unable to be contacted by phone in case of emergency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the acne lesion counts inflammatory and non inflammatory done at each kinetic of the treatment phase as compared to Day 0 Changes in the clinical scoring of acne severity using IGA scale at each kinetic of the treatment phase as compared to Day 0 Changes in the clinical scoring for oily touch and shiny aspect to be done at Day 0Timm Day 7 Day 14 and Day 28 as compared to clinical scoring for oily touch and shiny aspect at D0T0 Changes in measurement of sebum casual levels on forehead by Sebumeter SM 815 MPA 6 done at each kinetic of the treatment phase as compared to Day 0 Changes in measurement of sebum levels on forehead by Sebumeter SM 815 MPA 6 done post product usage at D0Timm as compared to the sebum casual level at D0T0. Changes in Skin Hydration usingCorneometer CM 825 MPA 6 at each kinetic of the treatment phase as compared to Day 0 Changes in TEWL using Tewameter at each kinetic of the treatment phaseas compared to Day 0Timepoint: Day 0 Day 7 Day 14 Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in measurement of sebum excretion levels on forehead by Sebumeter SM 815 MPA 6 done at each kinetic of the treatment phase as compared to Day 0 Changes in Skin dryness would be assessed basis visual assessments using the Dryness scale done at each kinetic of the treatment phase as compared to Day 0 Standard imaging using VISIA CR at each kinetic of the treatment phase as compared to Day 0 Self-Assessment Questionnaire at each kinetic of the treatment phase as compared to Day 0 Safety will be assessed by recording adverse events including cutaneous reactions related to the investigational products cutaneous acceptability throughout the study durationTimepoint: Day 0 Day 7 Day 14 Day 28 | — |
Countries
India
Contacts
Public ContactDr Annie Jain
CIDP Biotech India Pvt. Ltd.
Outcome results
None listed