A Pilot Study of HP802-247 in Dystrophic Epidermolysis Bullosa

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01528306
• Date of registration: 31/01/2012
• Prospective Registration: Yes
• Primary sponsor: Healthpoint
• Public title: A Pilot Study of HP802-247 in Dystrophic Epidermolysis Bullosa
• Scientific title: An Exploratory, Cross-Over Study of the Safety of HP802-247 Applied to Open Wounds of Subjects With Dystrophic Epidermolysis Bullosa
• Date of first enrolment: March 2012
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01528306
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Jaime E Dickerson, PhD
• Affiliation: Healthpoint

• Name: Herbert B Slade, MD
• Affiliation: Healthpoint

Key inclusion & exclusion criteria

Inclusion Criteria:

- Written consent must be obtained from a parent or legally authorized representative.
Assent will be obtained according to local requirements.

- Subjects with a clinical diagnosis of DEB with recurring blisters, = 2 years of age
at Screening. Subjects may be of either sex and of any race or skin type provided
that their skin color, in the opinion of the Investigator, will not interfere with
the study assessments.

- A parent or legally authorized representative must be willing and able to ensure
subject is present for all required study visits.

- A parent or legally authorized representative must be able to follow instructions.

- Have an open wound for = 72 hours that:

- is still open and has not scabbed or crusted over

- has no dermatologic disease and/or condition in the treatment area (other than
DEB with recurring blisters), including active or recent infection (within 7
days) that may be exacerbated by treatment, require treatment with antibiotics /
antifungals /antivirals, require a surgical intervention, or cause difficulty
with examination

- is = 4 cm² and = 48 cm2 in total area (open portion)

- Females of childbearing potential (defined as post-menarcheal as documented in the
medical history) may participate in the study if they meet all of the following
conditions:

- they are not breast feeding;

- they have a negative urine pregnancy test at Week 1 Period 1;

- they agree to undertake scheduled urine pregnancy tests at Week 1 for Periods 1,
2, & 3 and at study exit

- they do not intend to become pregnant during the study;

- they are using adequate birth control methods and they agree to continue using
those methods for the duration of the study

- A parent or legally authorized representative must be willing and able to ensure
subject is present for all required study visits (for minor subjects)

- A parent or legally authorized representative must be able to follow instructions
(for minor subjects)

Exclusion Criteria:

- Contraindications or hypersensitivity to the use of the test article, their
components (e.g., aprotinin, fibrinogen), or substances used in the manufacture of
the test article (e.g., penicillin, streptomycin, amphotericin B, bovine serum
albumin).

- Therapy with another investigational agent within thirty (30) days of the Screening
Visit, or during the study.

- Have uncontrolled intercurrent or chronic illness that, in the opinion of the
Investigator, would limit compliance with study requirements, represents a potential
safety risk, or require treatment with an excluded drug/treatment.

- The Investigator or Medical Monitor may declare any subject ineligible for a valid
medical reason.



Age minimum: 2 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Dystrophic Epidermolysis Bullosa

Intervention(s)

Other: Placebo

Biological: HP802-247

Primary Outcome(s)

Time to healing [Time Frame: 4 weeks]

Secondary Outcome(s)

Persistence of healing [Time Frame: 4 weeks for each of 3 treatment periods]

Burning and stinging upon application [Time Frame: 4 weeks for each of 3 treatment periods]

Percent of change in wound area [Time Frame: 4 weeks for each of 3 treatment periods]

Wound pain as measured by faces pain scale [Time Frame: 4 weeks for each of 3 treatment periods]

Secondary ID(s)

802-247-09-026

Source(s) of Monetary Support

Please refer to primary and secondary sponsors