Study to evaluate the safety and efficacy of Skin care product for its non-comedogenic effect

Phase 2/3

Completed

• Conditions: Other acne,

• Registration Number: CTRI/2023/09/057974
• Lead Sponsor: Kreative Beauty Private Limited

Brief Summary

After obtaining the Ethics committeeapproval subjects will be asked to visit the site. Informedconsent will be provided to the studyvolunteers, and after obtaining their consent, the subjects will be asked about their medical history andthe Investigator or his/her designeewill conduct a physical examination. Demographics and vital signs will be recorded. Subjects will be instructed toavoid using their own moisturizersand face serum for at least one week beforecommencement of this study. Once the subjects are found eligible they will be provided with the IP and advised to use ona daily basis. The product efficacyis determined by performing the assessmentslike Pore Indicator Test and assessment of Comedones (GAGS Score). Also Videodermoscopy will be done on Visit 1, Visit2 and Visit 3 which will also help us in seeing the difference in theappearance of comedones. They also will be advisedto fill the feedback questionnaires. The responses obtainedwill be statistically analyzed at the end of the trial to assess the safety and efficacy of the product.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-25
• Study Completion: 2023-11-12
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Healthy Indian male/female healthy volunteers aged between 18-55 years.
• 2.Willing to give Informed Consent Form.
• 3.Mild to moderate Black heads on the face 4.Willing to complete the study assessments/questionnaires.
• 5.Willing to avoid usage of his/her own moisturizers and face 6.serum for at least one week before Commencement and during this study.

Exclusion Criteria

• 1.Pregnancy or breast feeding.
• 2.Patients with pre-existing severe systemic disease necessitating long-term medication.
• 3.Patients with mild to severe Anaphylaxis reactions.
• 4.Evidence of significant uncontrolled co-morbid disease.
• 5.Historyofcancer,includingsolidtumors,hematologic malignancies and carcinoma in situ 6.Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments.
• 7.Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•To assess the safety and efficacy of the product for its non-comedogenic property	Day 1 to Day 28
Following parameters will be evaluated:	Day 1 to Day 28
•Appearance of black heads	Day 1 to Day 28
•Improvementin Spotcorrection by improving the appearance of large pores	Day 1 to Day 28

Secondary Outcome Measures

Name	Time	Method
To evaluate the consumer acceptance as well as their response towards the product through a feedback questionnaire.	Day 1 to Day 28

Trial Locations

Locations (1)

Shetty’s Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Shetty’s Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Madan Mohan N T

Principal investigator

8065733349

drmadan1969@gmail.com