Effect of New Topical Preparation for Treatment of Acne Vulgaris

June 10, 2023 updated by: Amgad E Salem, pHD, Mansoura University

Potential Combination Topical Therapy of Acne Vulgaris: a Randomized Controlled Trial Comparing Efficacy of DAP/FLU Micro-emulsion vs. Standard Therapy of Adapalene.

The investigators propose a randomized, double-blind control trial study to evaluate the efficacy and safety of the optimized topical combination ME of the investigated drugs in the treatment of acne vulgaris containing DAP-FLU in comparison with standard therapy of Adapalene at Mansoura University Dermatology and Andrology Outpatient Clinic.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Marwa Z. Mubarak
  • Phone Number: +201069910843

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Amgad El-Sayed Salem

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and females age 12 or older

  2. Clinical diagnosis of mild to moderate facial acne vulgaris defined as:

    1. ≥ 5 inflammatory lesions, and;
    2. ≥ 10 non-inflammatory lesions, and;
    3. IGA 2-3
  3. Willing to refrain from using any treatments, other than the investigational product, for acne present on the face. This includes the use of antibiotics for the treatment of acne.
  4. Willing and able to provide informed consent and to comply with the study protocol.

Exclusion Criteria:

  1. Women were excluded if they were pregnant, nursing, or planning a pregnancy as were men with facial hair that would interfere with the assessments.
  2. Continuous or planned use of tanning booths or excessive sun exposure, in the opinion of the Investigator.
  3. Treatment with systemic corticosteroids within 28 days prior to baseline.
  4. Two or more active nodular lesions.
  5. Use of androgen receptor blockers (such as spironolactone or flutamide) in the 7 days prior to randomization.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DAP/FLU ME
Acne vulgaris patients treated with the optimized topical combination ME contain DAP-FLU.
Drug: DAP-FLU ME
Combination therapy of topical anti-inflammatory agent (Dapsone 5%) and anti-androgenic agent (Flutamide 2.5%) with anti-bacterial agent of micro-emulsion component (tea tree oil 5%)
Active Comparator: Adapalene .1% gel
Acne vulgaris patients treated with standard therapy of Adapalene.
Drug: Adapalene .1% gel
Adapalene .1% gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Michaelson's acne severity index (ASI)
Time Frame: 8 Weeks

It's evaluated by counting non-inflammatory lesions (open and closed comedones) and inflammatory lesions (papules, pustules and nodules of at least 5 mm in diameter), and calculated as follows:

ASI = (comedones x 0.5) + (papules x 1) + (pustules x 2) + (nodules x 3).
8 Weeks
Safety assessment by the recording of patient-reported adverse events
Time Frame: 8 Weeks
Throughout the study
8 Weeks

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Study Director: Amgad El-Sayed Salem, Mansoura University
  • Study Director: Elham A. Mohamed, Mansoura University
  • Study Director: Noha M. Saleh, Mansoura University
  • Study Director: Marwa Z. Mubarak, Mansoura University
  • Principal Investigator: Galal M. Abdelghania, Mansoura University

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 (Estimated)

June 5, 2023

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

June 3, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 10, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A.S.2019-32

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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