Spironolactone versus Doxycycline for Acne: a Comparative Non-Inferiority Evaluation (SD-ACNE) Research Study

Oral antibiotics (e.g. doxycycline) are currently the most common systemic medication (pill) used to treat patients with acne. The SD-ACNE study is looking at whether spironolactone, which is a non-antibiotic treatment for women with acne, has similar effectiveness to oral antibiotics for acne. Both treatments are considered effective, but it is not known how they compare to each other.

With growing concerns about bacteria becoming resistant to antibiotics, there is a need to find alternative treatments for acne that are not antibiotics. By carrying out the SD-ACNE trial, we hope that women with acne might benefit in the future if this trial is successful and demonstrates that spironolactone is non-inferior or superior to oral antibiotics for acne.

This research study will include 400 women with acne ages 16-40 years old. It is being run in dermatology clinics across the United States.

What does this study involve?

Participants in this study will be randomly assigned to receive either spironolactone or doxycycline. That means they have a 50-50 chance of being assigned to one of these two accepted, common treatments. This study does not have a placebo group, which means that every participant in the study will receive a treatment for acne.

Taking part in the study involves an initial phone conversation with a member of the research team to assess whether you may be eligible to participate in the study. If you are potentially eligible, you will be scheduled for a screening visit at one of our trial sites to determine whether you may participate in the study. If you are enrolled in the study, you will start the study medication and be seen again 8 and 16 weeks after starting for follow-up study visits. At these visits you will have your acne evaluated by our study team and will complete questionnaires related to your acne and medical history. You may continue to use creams, gels or lotions for acne while in the study.

As a thank you for your participation, you will receive $100 after the completion of each study visit.

What are the risks and benefits of participation?

Participants in the SD- ACNE study may not receive any benefit from participating in this study. Your acne may not improve or could worsen.

The most common side effects of spironolactone include menstrual irregularities, breast tenderness and enlargement, low blood pressure, frequent urination headache, nausea and fatigue. Common side effects from doxycycline are rash, sensitivity to sunlight and gastrointestinal disturbances.

Get in touch

You can find out more and to contact us to see if you may be eligible to participate here. https://clinicalresearch.itmat.upenn.edu/clinicaltrial/6590/medical-research-randomized-double-blind-/?qd=2517013