Efficacy of Soulter Spotless Cream on reducing acne and acne scars
- Conditions
- Health Condition 1: L700- Acne vulgaris
- Registration Number
- CTRI/2021/09/036277
- Lead Sponsor
- PHARMADOCS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Subjects suffering from Acne Vulgaris and/or having acne scars. Participants willing to give written informed consent. Participants are fit and no need any hospital administration. Agree to following instruction of doâ??s and donâ??ts in regular daily lifestyle. Subjects willing to perform all study related procedures including the use of study oil, allow the physical and other tests and willing to document symptoms and medication. Subjects/ volunteers/ study participants {and /or legally accepted representative (LAR)} willing to give written informed consent and ability to adhere to dosing and visit schedules and meet study requirements.
Participants unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study. Inability to carry out visits for the study. Chronic & acute disorders requiring hospital admission. Known HIV-positive, Hepatitis B or C status. Volunteers/ study participants unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in skin status w.r.t. acne vulgaris. <br/ ><br>Lightens acne scars. <br/ ><br> <br/ ><br>Clinical assessment- 15 days. <br/ ><br>Global Acne Grading System (GAGS)- 15 days. <br/ ><br>Investigator Global Assessment of acne (IGA)- 15 days. <br/ ><br>Cardiff Acne Disability Index (CADI)- 15 days. <br/ ><br>Dermatology Life Quality Index (DLQI)- 15 days. <br/ ><br>Safety Assessment Scale- 15 days. <br/ ><br>Postinflammatory Hyperpigmentation Severity Scale- 15 days. <br/ ><br>Timepoint: Clinical assessment- 15 days. <br/ ><br>Global Acne Grading System (GAGS)- 15 days. <br/ ><br>Investigator Global Assessment of acne (IGA)- 15 days. <br/ ><br>Cardiff Acne Disability Index (CADI)- 15 days. <br/ ><br>Dermatology Life Quality Index (DLQI)- 15 days. <br/ ><br>Safety Assessment Scale- 15 days. <br/ ><br>Postinflammatory Hyperpigmentation Severity Scale- 15 days. <br/ ><br> <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Changes in quality of life (DLQI). <br/ ><br>Adverse Events. <br/ ><br> <br/ ><br>Timepoint: Changes in quality of life - DLQI - 15 days <br/ ><br>No incidence of Adverse events (AE) and Serious Adverse Events (SAE) during the study period - 15 days