A Substantial Equivalence Study of RD04723 and Predicate Device

Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01736969

Enrollment

Registered

2012-11-29

Start date

2012-08-31

Completion date

Unknown

Last updated

2012-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Scar, Keloid Scar

Brief summary

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.

Interventions

DEVICERD047-023

Experimental hydrogel

DEVICEPredicate Device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Comparison between groups in Vancouver Scar Scale total score from Baseline to Day 112 (or early termination)	4 weeks, 8 weeks, 12 weeks	Vascularity, height/thickness, pliability, and pigmentation. Scoring from zero to thirteen.

Secondary

Measure	Time frame	Description
Pain and itch	4 weeks, 8 weeks, 12 weeks	Patient assessment of pain and itch. Scoring from 0-3.
Adverse Events	Baseline, Weeks: 2, 4, 8, 12 and early termination	Number of subjects with related adverse events
Treatment satisfaction	8 weeks, 12 weeks	Patient assessment (satisfaction) with scar treatment. Stated as: very good, good, moderate or unsatisfactory.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026