A study to assess the efficacy of a vitamin D-containing ointment applied on the skin to improve wound healing in butterfly childre

Phase 1

• Conditions: Subjects with dystrophic epidermolysis bullosa (DEB) with a known mutation in the type VII collagen gene.; MedDRA version: 19.0Level: PTClassification code 10014989Term: Epidermolysis bullosaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2016-001967-35-AT
• Lead Sponsor: niversitätsklinik für Dermatologie, Paracelsus medizinische Privatuniversität Salzburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-28
• Last Update Posted: 10 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Signed Written Informed Consent
a) Subjects or legal guardians for minor children must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.

b) Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.

2. Target Population
a) Subjects with dystrophic epidermolysis bullosa (DEB) with a known mutation in the type VII collagen gene.

b) Subjects must have at least 2 wounds with a minimum size of 6 cm2 per wound.

3. Age and Reproductive Status
a) Children = 6 years, men and women.

b) Pregnant women are excluded from the study.

c) Women of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) must agree to use appropriate medically accepted highly effective methods of contraception (failure rate of less than 1% per year). Medically accepted highly effective methods of contraception are: 3-monthly contraceptive injection, combined oral hormonal contraceptive pills containing ethinyl estradiol and progestogens, oral hormonal contraception with Cerazette®, vaginal ring (e.g. NuvaRing®), contraceptive transdermal patch (e.g. Evra®), contraceptive implant (e.g. Implanon®) and gestagen-containing intrauterine device.
Negative Serum ß-Human Chorionic Gonadotrophin (ß-HCG) pregnancy test at screening and crossover.

d) Surgically sterilized female patients with documentation of prior
hysterectomy, tubal ligation or complete bilateral oophorectomy and postmenopausal women do not require contraception.

e) Women must not be breastfeeding.

Are the trial subjects under 18? yes
Number of subjects for this age range: 6
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Medical History and Concurrent Diseases
a) Simultaneous participation in another clinical trial.

b) Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.

c) Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications or antibiotics within14 days of study drug administration.

d) Subjects with known severely impaired kidney-or liver function.

e) Subjects with known disorders of calcium metabolism.

2. Allergies and Adverse Drug Reactions
a) History of a severe hypersensitivity reaction to calcipotriol or other study drug components.

3. Sex and Reproductive Status
a) Women of childbearing potential who are pregnant or breastfeeding.

b) Women with a positive pregnancy test at screening or crossover.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified