CTRI/2024/01/061563
Completed
Phase 2
A prospective, open-label, one arm study to evaluate the safety and efficacy of Efatop HYDRA GEL for its noncomedogenic effect in healthy male or female volunteers. - Non-comedogenic
ERIS LIFESCIENCES LTD.0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ERIS LIFESCIENCES LTD.
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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