DERMATOPHARMACOLOGY

Rhode Island Hospital
Jane Brown South 1
593 Eddy Street
Providence, RI 02903

Phone: (401) 444-7853
E-mail: jcambra@lifespan.org

John J. DiGiovanna, M.D., Director
Jennie J. Muglia, M.D., Associate Director
Dermatopharmacology Nurses

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WHO WE ARE

Established in 1990, the Dermatology Clinical Studies Unit is a group of dedicated individuals committed to excellence in clinical research across the spectrum of dermatology. The clinic is located at Rhode Island Hospital in Providence, Rhode Island and is affiliated with the Brown Medical School Department of Dermatology. Our clinical studies unit consists of two board certified dermatologists and three certified clinical research coordinators.

OUR GOAL

Our goal is to give our patients individualized, attentive care of the highest quality. In our earnest and on-going efforts to collect honest, accurate data, we strive to provide our study patients and sponsors with an effective, fulfilling clinical trial experience.

WHAT WE CAN DO

Our experienced staff has performed a wide variety of clinical studies. We are able to conduct a broad range of trials, ranging from Phase I through Phase IV.

Our research experience includes, but is not limited to:

• acne

• actinic keratoses

• atopic dermatitis

• cutaneous oncology including lymphoma and skin cancer

• sexually transmitted diseases

• cutaneous ulcers

• diseases of the scalp

• eczema

• fungal infections

• photo damage

• psoriasis

• rosacea

• skin infections

• warts

HOW DRUGS ARE TESTED

In compliance with government laws and regulations, a drug must undergo a series of research studies to prove that it is both effective and safe for use before the Food and Drug Administration (FDA) grants marketing approval.

CLINICAL RESEARCH STUDIES

A clinical research sutdy (or research trial) is a supervised evaluation of a medication to determine its safety and effectiveness as a treatment for a specific disease or condition.

All clinical research studies must follow a strict set of rules, or "protocol". Before any study begins, its protocol must be reviewed and approved by proper authorities including an Institutional Review Board (IRB). An IRB is an independent committee of medical and non-medical professionals brought together to assess a study's potential benefits and risks to ensure that: 1) participants are fully informed; 2) their rights and welfare are fully protected.

Participants in a clinical research study have certain rights before the study begins and while it is in progress. Participants:

• may ask questions at any time about the study or medication involved

• are entitled to an explanation of any risks, benefits and available alternative treatments, plus any significant new findings made during the study that could affect their willingness to continue as a participant.

INFORMED CONSENT

Informed consent is a written agreement, signed either by participants or their designated representatives, that certifies they have been fully informed about the nature of the research (ie. objectives, risks, benefits, procedures, etc.) and are willing to participate in the study.

By participating in a study, one may have access to cutting edge therapy and help provide valuable information to researchers about pharmaceuticals being tested. You may also benefit society by contributing to a better understanding a dermatologic condition, which could ultimately lead to the development of new or improved treatments.