Current partner codePEPTIDESDE
NCT00311766·Phase 2·INTERVENTIONAL

A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa

Status

Terminated

Phase

Phase 2

Enrollment

30

Locations

0

Results

Posted

Publications

0

Study summary

What the protocol is testing.

The purpose of this study is to investigate a treatment to enhance the healing of acute and chronic nonhealing cutaneous wounds, such as the erosions experienced by patients with Epidermolysis Bullosa (EB), by the known activity of thymosin beta 4 (Tβ4). Funding Source - FDA Office of Orphan Product Development (OOPD).

Full detailed description

EB is a group of genetic diseases characterized by skin-blistering and lesion-formation after minor trauma to the skin. This family of disorders, most of which are inherited, range in severity from mild to the severely disabling and life-threatening. 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.

Interventions

Treatment arms and agents.

DRUG

Thymosin Beta 4

Topical administration, 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days

DRUG

Placebo

Topical administration, 0.00% Thymosin Beta 4 gel qd up to 56 days

Timeline

From registration to results.

  1. First posted

    Apr 6, 2006

  2. Study start

    Feb 2006

  3. Primary completion

    Jul 2010

  4. Study completion

    Nov 2012

  5. Results posted

    Jun 10, 2013

  6. Registry updated

    May 12, 2014

Outcomes

What the study measures.

Primary outcomes

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame · 70 days

Secondary outcomes

Number of Participants Whose Wounds Have Healed

Time frame · 56 days

Wound healing means that the wound has closed without any drainage

Eligibility

Who can take part.

Minimum age
2 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Informed Consent form signed by the patient or patient's legal representative; also, if the patient is under the age of majority but capable of providing assent, signed assent from the patient * Diagnosis of junctional or dystrophic EB. * Patients who present with Hallopeau-Siemens subtype may be enrolled. * At least one active, unroofed EB erosion on the limb or on the trunk. * Lesion size 5 to 50 cm2, inclusive. * Stable lesion present for 14-60 days before enrollment. * More that one member in a family can be enrolled as long as that member is treated to a different cohort with an assurance that the study medication will not be shared. * No clinically significant abnormalities (Grade 2 or higher on the National Cancer Institute \[NCI\] toxicity scale) on Screening laboratory tests, except for the following specific laboratory threshold result: albumin must be 2 g/dL or higher; hemoglobin must be 8 g/dL or higher. Exclusion Criteria: * Clinical evidence of local infection of the index (targeted) lesion. * Use of any investigational drug within the 30 days before enrollment. * Use of immunotherapy or cytotoxic chemotherapy within the 60 days before enrollment. * Use of systemic or topical steroidal therapy within the 30 days before enrollment.Inhaled steroids are allowed. * Use of systemic antibiotics within the 7 days before enrollment. * Current or former malignancy. * Arterial or venous disorder resulting in ulcerated wounds. * Diabetes mellitus. * Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed at Screening for female patients of childbearing potential.)

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Thymosin Beta-4.

Related PeptideStat pages

Put the record in context.

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