NCT05899699

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

June 5, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

June 3, 2023

Last Update Submit

June 10, 2023

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

  • 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

  • Safety assessment by the recording of patient-reported adverse events

    Throughout the study

    8 Weeks

Study Arms (2)

DAP/FLU ME

EXPERIMENTAL

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

Drug: DAP-FLU ME

Adapalene .1% gel

ACTIVE COMPARATOR

Acne vulgaris patients treated with standard therapy of Adapalene.

Drug: Adapalene .1% gel

Interventions

DAP-FLU MEDRUG

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%)

DAP/FLU ME
Adapalene .1% gelDRUG

Adapalene .1% gel

Adapalene .1% gel

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amgad El-Sayed Salem

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

AdapaleneGels

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Amgad El-Sayed Salem

    Mansoura University

    STUDY DIRECTOR

  • Elham A. Mohamed

    Mansoura University

    STUDY DIRECTOR

  • Noha M. Saleh

    Mansoura University

    STUDY DIRECTOR

  • Marwa Z. Mubarak

    Mansoura University

    STUDY DIRECTOR

  • Galal M. Abdelghania

    Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amgad El-Sayed Salem

CONTACT

+201099805564amgadsalem@mans.edu.eg

Marwa Z. Mubarak

CONTACT

+201069910843

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer, pharmaceutical department, faculty of pharmacy

Study Record Dates

First Submitted

June 3, 2023

First Posted

June 12, 2023

Study Start

June 5, 2023

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations

EG(1)