None listed
Conditions
Interventions
Intervention1: NIL: NIL
Intervention2: NIL: NIL
Sponsors
Sami-Sabinsa Group Ltd
Alkem Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18 to 45 with mild to moderate Acne Vulgaris. Acne on the face, either non-inflammatory lesions (i.e., open and closed comedones) AND inflammatory lesions (i.e., papules and pustules). 2. Subjects with facial acne having IGA grade 1 and 2 3. Subjects with Oily & or Mixed type of facial skin. 4. Good general and mental health with, in the opinion of the investigator or medically qualified designee with no clinically significant and relevant abnormalities in medical history or upon physical examination 5. Willingness to participate as evidenced by voluntary written informed consent 6. Subject are willing to comply with study instructions and return to the clinic for required visits.
Exclusion criteria
Exclusion criteria: 1. Subject is pregnant, lactating, or is planning to become pregnant during the study. 2. Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy 3. Subject has greater than two (2) facial nodules. 4. Subject has nodulocystic acne 5. Subject is currently enrolled in an investigational drug or device study OR has been treated with an investigational product or device within 30 days prior to the initiation of treatment (Baseline) 6. Subject has facial hair especially full-grown beard that could interfere with the study assessments in the opinion of the investigator. 7. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits. 8. Subject has used any of the prohibited topical anti-acne treatments or procedures prior to the study unless appropriate washout period is documented. 9. Patients exhibiting acute or chronic dermatological, medical, and/or physical conditions which would preclude application of the test materials and/or influence the outcome of the study. 10. Patients who must use oral corticosteroids and/or oral immunosuppressive drugs (steroid inhalers or decongestant nose drops and/or eye drops are permitted). 11. Active dermatosis (local or disseminated) that might interfere with the results of the study. 12. History of diseases aggravated or triggered by ultraviolet radiation. 13. Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30days of the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Mean percent change from baseline to week 4 in the inflammatory (papules and pustules) lesion count 2.Mean percent change from baseline to week 4 in the Non-inflammatory (open and closed comedones) lesion count. Timepoint: Day 1, Day 7, Day 14, Day 21, and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Mean percent change from baseline to week 2/(D-14) in the inflammatory (papules and pustules) lesion count 2) Mean percent change from baseline to week 2/(D-14) in the Non-inflammatory (open and closed comedones) lesion count. 3) No. of patients showing improvement in the IGA score. 4) Frequency and severity of Adverse Events 5) The incidence of treatment-emergent adverse events 6) Application site reaction assessments 7) Tolerance evaluation scale Timepoint: week-2 9( Day 14) | — |
Countries
India
Contacts
Public ContactDr Shendkar Sonal Mahadev
Skinovate Laser and Cosmetic Surgery center
Outcome results
None listed