Novel Transdermal Ketoprofen Gel Formulation for Knee Osteoarthritis

December 21, 2025 updated by: Asmaa Ahmed Hamed Mohie Eldin, New Valley University

Novel Transdermal Ketoprofen Gel Formulation for Knee Osteoarthritis: Comprehensive In-Vitro and Clinical Assessment

A single blind randomized controlled clinical study

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A single blind randomized controlled clinical study

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Minya Governorate
      • Minya, Minya Governorate, Egypt, 11666
        • Minia university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient diagnosed with osteoarthritis in knee by:

Full history taking Physical examination including (joint tenderness, swelling, crepitus and limitation of motion).

Exclusion Criteria:

  • 1. Patients with dual diagnosis 2. Patients have skin lesion or dermatologic disease in the treatment area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: formulation arm
new formulation of ketoprofen
Drug: ketoprofen
new gel formulation
Drug: ketoprofen
commercial gel
Active Comparator: commercial product
positive control receiving commercial product
Drug: ketoprofen
new gel formulation
Drug: ketoprofen
commercial gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analogue Scale (VAS)
Time Frame: 2 weeks
2 weeks
McMaster Universities Arthritis Index (WOMAC)
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New Valley University

Investigators

  • Principal Investigator: Sara A Hassan, Badr University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

December 21, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 21, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Minia University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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