Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers (SSVS)

RegeneRx Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Venous Stasis Ulcers

Treatments: Drug: Placebo; Drug: Thymosin Beta 4

Study type: Interventional

Funder types: Industry

Identifiers

NCT00832091

SSVS

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers

Full description

The purpose of this double-blind, placebo-controlled, dose-response study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with Venous Stasis (VS) ulcers. VS ulcers develop on the ankle or lower leg in patients with chronic vascular disease. In these patients, blood flow in the lower extremities is impaired, leading to edema (swelling) and mild redness and scaling of the skin that gradually progress to ulceration. Tβ4 is a synthetically-produced copy of a naturally occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.

Enrollment: 72 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed Consent Form signed by the patient
• Male or female, between 18 and 79 years of age
• At least one venous leg ulceration stable for at least 6 weeks before enrollment
• Surface area between 3 and 30 cm2

Exclusion criteria

• Have clinical evidence of active infection on the index ulcer
• Use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment
• Use of systemic or topical steroidal therapy, immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment
• History of adverse reaction to any ingredients of the study medication
• Clinically significant neurological, cardiovascular, respiratory, hepatic, renal, metabolic and dermatologic disease other than venous ulcers
• Current or former malignancy
• Arterial disorder resulting in ulcerated ulcers
• Diabetes mellitus
• Pregnant or lactating (breastfeeding) women. A serum pregnancy test will be performed at screening for female patients of childbearing potential

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

There are 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were 3 concentrations used for topical administration to the active drug groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days

Treatment:

Drug: Thymosin Beta 4

2

Placebo Comparator group

Description:

There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days

Treatment:

Drug: Placebo