Health Condition 1: L700- Acne vulgaris
Conditions
Interventions
Intervention1: Siracilt: Patients in all treatment groups will start using their respective topical treatment from the baseline visit and continue for 28 days throughout their participation in the stu
Sponsors
Frimline Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female patients with age 18 - 65 years, with acne vulgaris of face. 2. Written informed consent signed by patient and willing to comply with the study procedure. 3. Patients with mild to moderate acne, as determined by an Investigator Global Assessment (IGA) score of 2 to 3. 4. Females of childbearing potential must have a negative pregnancy test at screening and agree to use an acceptable form of contraception during the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant Lactating females. 2. Previous hypersensitivity or allergic reaction to any of the components in the study medication. 3. Patients with the skin conditions of the face such as open or incompletely healed wounds at the affected site or acute eczemas, rosacea, perioral dermatitis, atopic-seborrheic dermatitis or psoriasis. 4. Use of topical acne medication within the past 1 weeks. 5. Any significant dermatological condition or skin infection other than acne vulgaris that may interfere with the study assessments. 6. Patients with the significant cardiovascular, hepatic, renal or any other systemic illnesses. 7. Use of any Investigational drug or participation in another clinical trial within the past 30 days. 8. Any other medical or psychological condition that, in the opinion of the investigator, may interfere with the patients ability to participate in the study or complete the study assessments. 9. Any condition or situation that, in the investigators judgment, may put patient at risk or compromise the integrity of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator Global Assessment (IGA) score of 0 or 1 and/or at least a two-point reduction in IGA score compared to baseline.Timepoint: 1. Baseline 2. Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage reduction in the number of acne lesions -papules, pustules, and nodules- from baseline to the end of the treatment period. Timepoint: 28 Days;2. Change from baseline to week 4 in inflammatory lesion. Timepoint: 28 Days;3. Change from baseline to Week 4 in the count of non-inflammatory lesions -open and closed comedones. Timepoint: 28 Days;4. Change from baseline to week 4 in total lesions.Timepoint: 28 Days;5. Adverse events reported during the study. Timepoint: 28 Days | — |
Countries
India
Contacts
Public ContactRakesh Ray
RYT Life Sciences
Outcome results
None listed