Effect of New Topical Preparation for Treatment of Acne Vulgaris

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-05

Study Completion Date

2023-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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DAP/FLU ME

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

Group Type EXPERIMENTAL

DAP-FLU ME

Intervention Type DRUG

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

Acne vulgaris patients treated with standard therapy of Adapalene.

Group Type ACTIVE_COMPARATOR

Adapalene .1% gel

Intervention Type DRUG

Adapalene .1% gel

Interventions

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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%)

Intervention Type DRUG

Adapalene .1% gel

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No