Effect of New Topical Preparation for Treatment of Acne Vulgaris

Phase 2

Not yet recruiting

• Conditions: Acne Vulgaris
• Interventions: Drug: Adapalene .1% gel; Drug: DAP-FLU ME

• Registration Number: NCT05899699
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-03
• Study Start: 2023-06-05
• Study First Submitted QC: 2023-06-09
• Last Update Submitted: 2023-06-10
• Study First Posted: 2023-06-12
• Last Update Posted: 2023-06-13
• Primary Completion: 2023-09-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adapalene .1% gel	Adapalene .1% gel	Acne vulgaris patients treated with standard therapy of Adapalene.
DAP/FLU ME	DAP-FLU ME	Acne vulgaris patients treated with the optimized topical combination ME contain DAP-FLU.

Primary Outcome Measures

Name	Time	Method
Safety assessment by the recording of patient-reported adverse events	8 Weeks	Throughout the study
Michaelson's acne severity index (ASI)	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).

Trial Locations

Locations (1)

Amgad El-Sayed Salem; 🇪🇬 Mansoura, Egypt