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 range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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