Dystrophic epidermolysis bullosa (DEB) Skin and Connective Tissue Diseases Epidermolysis bullosa
Conditions
Interventions
Up to ten selected lesions per subject will be randomised to receive ICX-RHY-013 or placebo. Randomisation will be performed within each subject, using a computer generated randomisation scheme. A sin
Sponsors
Intercytex Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who have a clinical diagnosis of dystrophic epidermolysis bullosa, either autosomal recessive or autosomal dominant 2. Subjects who are =16 and =70 years of age 3. Subjects with at least 5 open skin erosions which are located on the limbs or the trunk, each with a surface area between 5cm sq and 50cm sq. The size of these erosions must not exceed 50cm^2 at baseline 4. Subjects who have voluntarily signed and dated an Informed Consent Form (ICF) prior to the first study intervention 5. Subjects, who are, in the opinion of the Investigator, able to understand the study, co-operate with the study procedures and are willing to return to the clinic for all the required follow-up visits
Exclusion criteria
Exclusion criteria: 1. Subjects who have received immunotherapy or chemotherapy within 60 days of enrolment into this study 2. Subjects with a known allergy to any of the constituents of the product 3. Subjects with known or suspected malignancy 4. Subjects with intolerance or allergy to additional study-associated drugs / therapies (e.g. anaesthetic etc) 5. Subjects who have taken systemic antibiotics within 7 days 6. Subjects taking immunosuppressive therapy including systemic steroids (i.e., oral prednisolone > 40mg for more than 1 week, intranasal / inhaled steroids are acceptable) within the 30 days of the first treatment or planning immunosuppressive therapy at any time during the study 7. Subjects who have taken any other investigational product within 90 days prior to screening or planned use of any other investigational product during the study period 8. Subjects who are pregnant, planning pregnancy and women of child-bearing potential who are not abstinent or practicing an acceptable means of contraception, as determined by the Investigator, for the duration of the treatment phase 9. Subjects with abnormal laboratory findings considered clinically significant 10. Subjects with a known history of poor adherence/compliance with medical treatment or follow up 11. Subjects who are unable to understand the aims, objectives and follow-up treatment 12. Subjects with known alcohol or narcotic drug dependence 13. Subjects who have previously been screened on more than two occasions, or who have previously been treated under this protocol 14. Subjects who have previously been treated with ICX-RHY-013 and who have an immune response for collagen VII antibody detected by immunofluorescence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the time to wound closure of skin erosions treated with ICX-RHY-013 with those treated with placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Wound area over treated areas using standard methodology (wound surface area measurements) 1.1. Wound surface area measurements at every study visit using photography and digital planimetry software will be used to measure change in wound surface area. 2. Erosion pain - study subjects will undertake pain and quality of life assessments by completing a quality of life questionnaire. 3. Wound recurrence 4. Adverse events for 12 weeks 5. Clinical laboratory safety assessment at 4 and 12 weeks 6. Clinical assessment of change in the treated area (photographic evidence) | — |
Countries
United Kingdom
Outcome results
None listed