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

Phase 2
Completed
Registration Number
CTRI/2024/01/061563
Lead Sponsor
ERIS LIFESCIENCES LTD.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

1.Healthy Indian male/female healthy volunteers aged between 18-55 years.

2.Willing to give Informed Consent Form.

3.Subjects with Clear to mild skin condition according to GAGS score 0 to 2.

4.Willing to complete the study assessments/questionnaires.

5.Willing to avoid usage of his/her own skin care products 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,includingsolidtumours,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
NameTimeMethod
• To assess the safety and efficacy of skin care product for its non-comedogenic property. <br/ ><br>Following parameters will be evaluated: <br/ ><br>• Appearance of black heads through Videoscopy. <br/ ><br>• Assessments of blocked pores through pore indicator test. <br/ ><br>Timepoint: Day 0 to Day 30 <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
• To evaluate the consumer acceptance as well as their response towards the product through a feedback questionnaire.Timepoint: Day 0 to Day 30
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