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

Terminated

• Conditions: Fungal Infection; Chronic Pain

• Registration Number: NCT02445235
• Lead Sponsor: Bracane Company

Brief Summary

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.

Detailed Description

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.

Patients are enrolled for 18 months. The investigator will complete a global patient assessment monthly of the patient's condition.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-08
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-15
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-18
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

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

Exclusion Criteria

1. Pregnant or lactating females or women at the child bearing potential not using effective contraception.
2. 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 Patients may be withdrawn for a period of 2 weeks from all topical or transdermal medications prior to study initiation.
3. Hypersensitivity to local anesthetic or other ingredients of the compounded creams to be used in a study.
4. 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
5. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Baseline PRO and Health Status Perception	Up to eighteen (18) months

Trial Locations

Locations (3)

BG Research; 🇺🇸 Lexington, Kentucky, United States

Associates of Internal Medicine; 🇺🇸 Fort Worth, Texas, United States

Sevierville Foot and Ankle Clinic; 🇺🇸 Sevierville, Tennessee, United States