Efficacy and safety of the lactoferrin- containing cream in treating mild to moderate acne vulgaris.
- Conditions
- Health Condition 1: L700- Acne vulgaris
- Registration Number
- CTRI/2024/01/061604
- Lead Sponsor
- Frimline Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>2. Week 4
- Secondary Outcome Measures
Name Time Method 1. Percentage reduction in the number of acne lesions -papules, pustules, and nodules- from baseline to the end of the treatment period. <br/ ><br>Timepoint: 28 Days;2. Change from baseline to week 4 in inflammatory lesion. <br/ ><br>Timepoint: 28 Days;3. Change from baseline to Week 4 in the count of non-inflammatory lesions -open and closed comedones. <br/ ><br>Timepoint: 28 Days;4. Change from baseline to week 4 in total lesions.Timepoint: 28 Days;5. Adverse events reported during the study. <br/ ><br>Timepoint: 28 Days