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Therapeutic Equivalence of Diclofenac Sodium Gel 3% vs Solaraze ® in the Treatment of Actinic Keratosis

NCT03826550 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 655

Last updated 2019-02-01

No results posted yet for this study

Summary

Therapeutic Equivalence of Diclofenac Sodium Gel 3% and Solaraze ®, in the treatment of Actinic Keratosis

Conditions

  • Actinic Keratoses

Interventions

DRUG

Diclofenac Sodium Gel

Twice daily for 60 days. Each patient is expected to receive 120 doses

DRUG

Solaraze 3% Topical Gel

Twice daily for 60 days. Each patient is expected to receive 120 doses

OTHER

Placebo

Twice daily for 60 days. Each patient is expected to receive 120 doses

Sponsors & Collaborators

  • Novum Pharmaceutical Research Services

    collaborator INDUSTRY

  • Encube Ethicals Pvt. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-12
Primary Completion
2018-06-30
Completion
2018-07-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03826550 on ClinicalTrials.gov