UnknownPhase 2

Effect of New Topical Preparation for Treatment of Acne Vulgaris

Egypt20 participantsStarted 2023-06-05

Plain-language 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.

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Michaelson's acne severity index (ASI)

Timeframe: 8 Weeks

Safety assessment by the recording of patient-reported adverse events

Timeframe: 8 Weeks

Trial details

NCT IDNCT05899699

SponsorMansoura University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-01

Contact for this trial

Amgad El-Sayed Salem

+201099805564 amgadsalem@mans.edu.eg

View on ClinicalTrials.gov More Acne Vulgaris trials