Back to resultsEffect of New Topical Preparation for Treatment of Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Not yet recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
DAP-FLU ME
Adapalene .1% gel
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria: Male and females age 12 or older Clinical diagnosis of mild to moderate facial acne vulgaris defined as: ≥ 5 inflammatory lesions, and; ≥ 10 non-inflammatory lesions, and; IGA 2-3 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. Willing and able to provide informed consent and to comply with the study protocol. Exclusion Criteria: Women were excluded if they were pregnant, nursing, or planning a pregnancy as were men with facial hair that would interfere with the assessments. Continuous or planned use of tanning booths or excessive sun exposure, in the opinion of the Investigator. Treatment with systemic corticosteroids within 28 days prior to baseline. Two or more active nodular lesions. Use of androgen receptor blockers (such as spironolactone or flutamide) in the 7 days prior to randomization.
Sites / Locations
- Amgad El-Sayed Salem
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DAP/FLU ME
Adapalene .1% gel
Arm Description
Acne vulgaris patients treated with the optimized topical combination ME contain DAP-FLU.
Acne vulgaris patients treated with standard therapy of Adapalene.
Outcomes
Primary Outcome Measures
Michaelson's acne severity index (ASI)
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).
Safety assessment by the recording of patient-reported adverse events
Throughout the study
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05899699
Brief Title
Effect of New Topical Preparation for Treatment of Acne Vulgaris
Official Title
Potential Combination Topical Therapy of Acne Vulgaris: a Randomized Controlled Trial Comparing Efficacy of DAP/FLU Micro-emulsion vs. Standard Therapy of Adapalene.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 5, 2023 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DAP/FLU ME
Arm Type
Experimental
Arm Description
Acne vulgaris patients treated with the optimized topical combination ME contain DAP-FLU.
Arm Title
Adapalene .1% gel
Arm Type
Active Comparator
Arm Description
Acne vulgaris patients treated with standard therapy of Adapalene.
Intervention Type
Drug
Intervention Name(s)
DAP-FLU ME
Intervention Description
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%)
Intervention Type
Drug
Intervention Name(s)
Adapalene .1% gel
Intervention Description
Adapalene .1% gel
Primary Outcome Measure Information:
Title
Michaelson's acne severity index (ASI)
Description
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).
Time Frame
8 Weeks
Title
Safety assessment by the recording of patient-reported adverse events
Description
Throughout the study
Time Frame
8 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and females age 12 or older
Clinical diagnosis of mild to moderate facial acne vulgaris defined as:
≥ 5 inflammatory lesions, and;
≥ 10 non-inflammatory lesions, and;
IGA 2-3
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.
Willing and able to provide informed consent and to comply with the study protocol.
Exclusion Criteria:
Women were excluded if they were pregnant, nursing, or planning a pregnancy as were men with facial hair that would interfere with the assessments.
Continuous or planned use of tanning booths or excessive sun exposure, in the opinion of the Investigator.
Treatment with systemic corticosteroids within 28 days prior to baseline.
Two or more active nodular lesions.
Use of androgen receptor blockers (such as spironolactone or flutamide) in the 7 days prior to randomization.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgad El-Sayed Salem
Phone
+201099805564
Email
amgadsalem@mans.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa Z. Mubarak
Phone
+201069910843
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amgad El-Sayed Salem
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elham A. Mohamed
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Noha M. Saleh
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marwa Z. Mubarak
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Galal M. Abdelghania
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amgad El-Sayed Salem
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Effect of New Topical Preparation for Treatment of Acne Vulgaris
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