Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision

NCT03876548 | Withdrawn Early Phase 1 FDA Device

• 1 other identifier: CSP-008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 6 month, single site, interventional, open label prospective clinical study to evaluate the effects of a cadexomer iodine gel on the prevention of recurrent keloid formation in patients undergoing keloid scar revision.

Conditions

Keloid Scar Following Surgery

Keywords

keloid

Outcome Measures

Primary Outcomes (4)

• Scar measurement with Silhouette Camera Imaging

  The keloid or keloid scar will measured using the Silhouette Camera Imaging System

  24 weeks

• Patient and Observer Scar Assessment Scale (Subject facing)

  Patient and Observer Scar Assessment to be completed by the subject with the physician.

  24 weeks

• Patient and Observer Scar Assessment Scale (Non-Subject facing)

  Patient and Observer Scar Assessment to be completed by the physician only.

  24 weeks

• Response Rate calculation

  Response Rate calculation = Complete Remission + Partial Response (RR= CR + PR)

  24 weeks

Secondary Outcomes (1)

• Dermatology Quality of Life Index

  24 Weeks

Study Arms (1)

Cadexomer Iodine Gel

EXPERIMENTAL

Patients willy apply product to treatment site every other day for the next 28 days and cover with dressing or bandage.

Device: Cadexomer Iodine Gel

Interventions

Cadexomer Iodine Gel DEVICE

Subjects will apply gel product to keloid scar site every other day for 28 days following keloid scar revision surgery.

Cadexomer Iodine Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each subject must meet the following criteria to be enrolled in this trial:
• Male or female 18 years or older
• Subject is healthy, as determined by the investigator based on a medical evaluation and history
• Subject has an established diagnosis of keloid scar formation
• Subject's keloid is on the arm or chest but not on the wrist, elbow, or antecubital fossa
• Subject has one or more keloids eligible for scar revision
• Subject has a keloid of appropriate size (1 to 2.5 cm in length, 4 to 5 mm in width, and 3 to 4 mm in height)
• Subject has no known allergies to study products
• Subject is willing and able to avoid total body water exposure from large bodies of water such as pools, lakes, oceans, etc. while using study medication
• Subject is willing and able to comply with the requirements of the protocol
• Subject is male or non-pregnant, non-lactating woman. Women must be one of the following:
• Naturally postmenopausal defined as ≥1 year without menses and:
• ≥ 55 years or
• \< 55 years with follicle-stimulating hormone (FSH)≥40.0 IU/L, or
• Surgically sterile including hysterectomy, bilateral oophorectomy, and/or tubal ligation, or

You may not qualify if:

• Each subject must meet the following criteria to be enrolled in this trial:
• Subject has an underlying known disease, a surgical or medical condition that in the opinion of the investigator might put the subject at risk
• Subject's keloid scar is on the wrist, elbow, or antecubital fossa.
• Subject is pregnant or breastfeeding at the time of enrollment or is planning to become pregnant at any point during the study period
• Subject has a past history of coagulopathy
• Subject has an underlying dermatological disease that in the opinion of the investigator could interfere with the study evaluations
• Subject is treated with anticoagulants or antiplatelet therapies
• Subject has a known allergy or sensitivity to any local anesthetic (such as lidocaine) or a local topical antiseptic that may be used (such as iodine)
• Subject has known allergic reaction to the study product
• Subject has a known history of shellfish allergy or sensitivity
• Subject has known history of Hashimoto's Thyroiditis, Graves' disease, a thyroid disorder, a non-toxic goiter
• Subject is taking Lithium, Sulphafurazoles or Sulphonylureas
• Subject is prone to Vasovagal syncope
• Subject is unable to provide signed and dated informed consent form

Sponsors & Collaborators

• Next Science TM: lead
• Jacksonville Center For Clinical Research: collaborator

Study Sites (1)

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Bernhardt, MD

  Jacksonville Center For Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open label
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pilot study

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 15, 2019
• Study Start: February 7, 2019
• Primary Completion: June 1, 2019
• Study Completion: June 30, 2019
• Last Updated: August 26, 2019

Record last verified: 2019-08

Locations

US (1)