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Clinical Trials/CTRI/2024/01/061563
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.

Registry
who.int
Start Date
TBD
End Date
March 15, 2024
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
ERIS LIFESCIENCES LTD.

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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