Study to Evaluate Outcomes of Patients Receiving Treatment for Wound Care, Pain Management or Surface Skin Scar Therapy

Stopped early

Conditions studied: Chronic Pain, Fungal Infection

In brief

This observational study is designed to evaluate the reported outcomes for patients receiving topical therapy for the treatment of pain, fungal infections or skin scars. The patients will complete the Patient Reported Outcome (PRO) survey monthly and provide valuable data on the patients perception of their health status and well being while receiving therapy.

Key facts

Study ID

NCT02445235

Run by

Bracane Company

People needed

88

Starts

2015-04-01

Expected to finish

2016-01-01

Last updated by the study team

2016-01-20

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• An 18 to 85 years old (inclusive) female or male patient
• Prescribed compound for the treatment of pain, wound healing or surface skin scar by their Principal Investigator
• Any systemic disease (cardiac, renal, or hepatic) must be well controlled.
• Has no skin lesions at the site of application of study medication except for wound under treatment
• Able to provide informed consent

You may not qualify if…

• Pregnant or lactating females or women at the child bearing potential not using effective contraception.
• Use of other topical or transdermal medication. Patients may be withdrawn for a period of 2 weeks from all topical or transdermal medications prior to study initiation.
• Hypersensitivity to local anesthetic or other ingredients of the compounded creams to be used in a study.
• Prior reconstruction skin surgery or skin grafts in the area of cream application preventing absorption of cream except for the treatment of surface skin scar
• Chronic pain conditions not expected to respond to topical pain medication such as deep abdominal pain, or from conditions such as cancer, or gouty arthritis.

Where it is running

• BG Research — Lexington, Kentucky, United States
• Sevierville Foot and Ankle Clinic — Sevierville, Tennessee, United States
• Associates of Internal Medicine — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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