None listed
Conditions
Interventions
Intervention1: AcneStar gel: AcneStar gel belongs to a class of antibiotics known as lincomycin antibiotics that works by
preventing or stopping the bacterial growth. This combination medicine is pri
Sponsors
Mankind Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female and male subjects aged 18 - 35 years. 2. Skin phototype IV -V (Fitzpatrick). 3. Subjects having oily skin type, 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. Subjects presenting acne lesions count: a.= 10 to = 20 inflammatory acne lesions on whole face. b. = 25 non-inflammatory acne lesions on whole face. 6. Willing not to go for U.V. sessions/sun tanning/sun-bathing during the study duration. 7. Subjects agreeing to use only the supplied test product provided during the study. 8. Subjects informed about the study objectives and procedures, and able to understand them. 9. Subjects willing and able to fulfill the study requirements and schedule. 10. Subjects willing to provide written informed consent and are able to understand English or Hindi. 11. Male subjects willing not to use razor at least 24 hours before the evaluation visit and not to shave in opposite direction throughout the study duration. Male subject can use a trimmer to trim the moustache and beard, if possible. 12. Subjects willing to avoid oily, greasy, junk food and high sugar food items, as much as possible during the study period. 13. Subjects willing not to apply hair oil and wash their hair within 48 hours prior to the all evaluation visits. 14. 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)] 15. Female of childbearing potential, who is not sexually active, 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. Subjects with any kind of history of liver disorder 5. History of allergies, hypersensitivity or any serious reactions to salicylic acid and/or any other ingredients of the investigational product and/or face wash. 6. Any significant skin pathology in the test areas, like rosacea, severe acne, or eczema. 7. Any significant medical condition that would interfere with the participation in the trial, as per opinion of the Investigator. 8. 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. 9. 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 4 weeks prior to participation in the study, and during the study. 10. Any dermatological procedure on the face (laser peel, dermabrasion etc.) taken 4 weeks before the start of the study and during the study. 11. 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. 12. Having participated in the last 30 days before screening or currently participating in another clinical study. 13. Unable to be contacted by phone in case of emergency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of the face gel 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 ? Clinical Grading of Contrast of isolated pigmentary spot (PIH) ? Evaluation of 2 target inflammatory lesions for erythema assessment. 2. Evaluation of sebum excretion rate using Sebumeter SM 815®/MPA 6. Timepoint: Day 0, 3,7,14,28,56 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Measurement of color of isolated pigmentary spot using Chromameter CR 400. 2. Providing visual support of its efficacy by digital photography using VISIA-CR. 3. To assess the efficacy of investigational product by subjective appreciation of the efficacy and organoleptic characteristics of the investigational products 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 0, 3, 7,14,28,56 | — |
Countries
India
Contacts
Public ContactDeepika Arora
CIDP BIOTECH INDIA PVT LTD.
Outcome results
None listed