None listed
Conditions
Interventions
Intervention1: Acnestar Facewash: AcneStar face wash is a medicated anti-acne face wash which helps to fight with acne in an effective way. Its common ingredients are Glycolic acid, Salicylic acid, Tu
Sponsors
Mankind Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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 Grade 0 to Grade 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 left forehead = 120 µg/cm2 (mean). 7. Subject willing not to go for U.V. sessions/sun tanning/sun-bathing during the study duration. 8. 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. 15. Female of childbearing potential willing to undergo urine pregnancy test (self-declared by subject on screening visit and test to be done on Baseline visit (Day 0) or who is using an effective contraceptive method for at least one month before the beginning of the study, and throughout the study
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. Subjects with a history of severe alcohol intake and/or smoking habits 4. History of allergies, hypersensitivity or any serious reactions to any ingredients of the investigational products. 5. Any significant skin pathology in the test area (face), like rosacea, severe acne, eczema, and other. 6. Any significant medical condition that would interfere with the participation in the study, as per opinion of the Investigator. 7. 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. 8. Any topical or systemic treatment that could interfere with the study treatments/assessments (topical benzoyl peroxide and other antiacne or anti-seborreic products, antibiotics, corticosteroids, retinoids, anti-inflammatory drugs) within the last 4 weeks prior to participation in the study, and during the study. 9. Any dermatological procedure on the face (laser peel, dermabrasion etc.) taken 4 weeks before the start of the study and during the study. 10. 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. 11. Having participated in the last 30 days before screening or currently participating in another clinical study. 12. Unable to be contacted by phone in case of emergency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the efficacy of the face wash on acne prone and oily skin of subjects as determined by below mentioned parameters: ?Acne lesion counts (inflammatory & non-inflammatory) ?Oily touch ?Shiny aspect ?IGA scoring 2.Evaluation of sebum excretion rate using Sebumeter SM 815®/MPA 6. 3.Evaluation of Skin Hydration using Corneometer CM 825®/MPA 6. 4.Evaluation of TEWL (Transepidermal water loss) using Tewameter TW300®/MPA 6. 5.Evaluation of Skin Dryness using the Dryness Scale. Timepoint: Day 3, 7, 14 and 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of sebum casual levels using Sebumeter SM 815®/MPA 6. 2. Providing visual support of product efficacy by digital photography using VISIA-CR. 3. To assess the efficacy of investigational product by subjective appreciation of the efficacy of the investigational products and changes to skin condition through self-assessment questionnaire. 4. To assess the safety and cutaneous acceptability of the investigational product throughout the study duration by monitoring AE or/and LI. Timepoint: Day 3, 7, 14 and 28 | — |
Countries
India
Contacts
Public ContactMs Deepika Arora
CIDP Biotech India Pvt. Ltd.
Outcome results
None listed