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A Pilot Study of HP802-247 in Dystrophic Epidermolysis Bullosa

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01528306
First Posted: February 8, 2012
Last Update Posted: May 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Healthpoint
  Purpose
This is a pilot study designed to see if HP802-247, an investigational treatment with living human skin cells, helps to heal blisters or wounds in subjects with Dystrophic Epidermolysis Bullosa (DEB). The durability of the skin in healed wounds treated with HP802-247 will also be assessed.

Condition Intervention Phase
Dystrophic Epidermolysis Bullosa Biological: HP802-247 Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Exploratory, Cross-Over Study of the Safety of HP802-247 Applied to Open Wounds of Subjects With Dystrophic Epidermolysis Bullosa

Resource links provided by NLM:


Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • Time to healing [ Time Frame: 4 weeks ]
    Time to healing, defined as the number of days between wound onset (caregiver reported) and complete epithelialization (Investigator assessed).


Secondary Outcome Measures:
  • Wound pain as measured by faces pain scale [ Time Frame: 4 weeks for each of 3 treatment periods ]
    Change from baseline (i.e., Week 1 of each period) in wound pain for each visit (Weeks 2-5 of each treatment period)as assessed by the Faces Pain Scale (FPS)

  • Percent of change in wound area [ Time Frame: 4 weeks for each of 3 treatment periods ]
    Percent of change from baseline (i.e., Week 1 of each period) in the target wound area for each visit and Weeks 2-5 of each treatment period.

  • Persistence of healing [ Time Frame: 4 weeks for each of 3 treatment periods ]
    Persistence of healing as assessed by lack of blister/wound recurrence for healed wounds of each period (up to 40 weeks following enrollment)

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

    Burning and stinging upon application of HP802-247 or its Vehicle will be assessed at each visit of each period with the exception of the end of treatment visit (Weeks 1-4 of treatment period).

    Burning/stinging scale is a four point scale (i.e., none, mild, moderate, severe).



Enrollment: 0
Study Start Date: March 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HP802-247 Biological: HP802-247

Wounds up to 12 cm2: 1 spray each component (0.5 x 106 cells per mL allogeneic human keratinocytes and fibroblasts) applied weekly as a topical spray for up to 4 weeks in each of 2 treatment periods

Larger wounds:

(>12 cm2 and ≤ 24 cm2) 2 sprays each; (>24 cm2 and ≤ 36 cm2) 3 sprays each; (>36 cm2 and ≤ 48 cm2) 4 sprays each

Placebo Comparator: Placebo (Vehicle) Other: Placebo

Wounds up to 12 cm2: 1 spray each component (thrombin solution and fibrinogen solution) applied weekly as a topical spray for up to 4 weeks in each of 2 treatment periods

Larger wounds:

(>12 cm2 and ≤ 24 cm2) 2 sprays each; (>24 cm2 and ≤ 36 cm2) 3 sprays each; (>36 cm2 and ≤ 48 cm2) 4 sprays each


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528306


Sponsors and Collaborators
Healthpoint
Investigators
Study Chair: Herbert B Slade, MD Healthpoint
Study Director: Jaime E Dickerson, PhD Healthpoint
Principal Investigator: Herbert B Slade, MD Healthpoint
  More Information

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01528306     History of Changes
Other Study ID Numbers: 802-247-09-026
First Submitted: January 31, 2012
First Posted: February 8, 2012
Last Update Posted: May 16, 2012
Last Verified: May 2012

Keywords provided by Healthpoint:
HP802-247
EB (epidermolysis bullosa)

Additional relevant MeSH terms:
Epidermolysis Bullosa
Epidermolysis Bullosa Dystrophica
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous
Collagen Diseases
Connective Tissue Diseases