A Substantial Equivalence Study of RD04723 and Predicate Device

Oculus Innovative Sciences

Status: Unknown

Conditions: Hypertrophic Scar; Keloid Scar

Treatments: Device: Predicate Device; Device: RD047-023

Study type: Interventional

Funder types: Industry

Identifiers

NCT01736969

MSM-RD-023

Details and patient eligibility

About

The purpose of this study is to determine whether a developmental formulation is substantially equivalent to the predicate device in the treatment of hypertrophic and keloid scars.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to provide informed consent and release health information
• Ability to follow study instructions and study requirements
• Have a hypertrophic or keloid scar accessible for treatment and evaluation
• Negative pregnancy test for women of childbearing potential
• Agreement to use effective birth control method for study duration

Exclusion criteria

• History of allergy or sensitivity to components
• History of diabetes
• History of collagen vascular disorders
• Anticipated need for surgery or hospitalization during the study
• Pregnant, nursing, or planning a pregnancy during the study
• Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups

RD047-023

Experimental group

Description:

RD-047-023

Treatment:

Device: RD047-023

Predicate Device

Active Comparator group

Description:

legally marketed predicate device

Treatment:

Device: Predicate Device