Effect of New Topical Preparation for Treatment of Acne Vulgaris

Mansoura University

Status and phase: Not yet enrolling; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Adapalene .1% gel; Drug: DAP-FLU ME

Study type: Interventional

Funder types: Other

Identifiers

NCT05899699

A.S.2019-32

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups

DAP/FLU ME

Experimental group

Description:

Acne vulgaris patients treated with the optimized topical combination ME contain DAP-FLU.

Treatment:

Drug: DAP-FLU ME

Adapalene .1% gel

Active Comparator group

Description:

Acne vulgaris patients treated with standard therapy of Adapalene.

Treatment:

Drug: Adapalene .1% gel