Effect of New Topical Preparation for Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05899699
• Other study ID #: A.S.2019-32
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 5, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: June 2023
• Source: Mansoura University
• Contact: Amgad El-Sayed Salem
• Phone: +201099805564
• Email: amgadsalem[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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%)
• Adapalene .1% gel
Adapalene .1% gel

Locations

Country	Name	City	State
Egypt	Amgad El-Sayed Salem	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	8 Weeks
Primary	Safety assessment by the recording of patient-reported adverse events	Throughout the study	8 Weeks