Clinical Trials

 

A Phase I/II Clinical Trial of Topical KB105, a Replication-incompetent, Non-integrating HSV-1 Vector Expressing Human Transglutaminase 1 (TGM1) for the Treatment of TGM1-deficient Autosomal Recessive Congenital Ichthyosis (ARCI)

Intervention Type: Biological
Study Type: Interventional
Sponsors: Krystal Biotech, Inc.
Participants: 6
Abstract
This study is an intra-patient comparison of KB105 and placebo-administered Target Areas. The primary objectives of this study are to evaluate safety and Investigator Global Assessment (IGA) scale improvement of topically administered KB105.
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Facilities
Paddington Testing Company, Inc. - Recruiting
Philadelphia, United States of America
Contacts
Backup
Hirak B Routh, MDDS
hirakbrouth@gmail.com
(215) 563-7330
Primary
Lawrence C Parish, M.D.
larryderm@yahoo.com
(215) 563-7330
Eligibilities
Sex: All
Minimum Age: 18
Healthy Volunteers: No
Inclusion Criteria:
- Genetic diagnosis of TGM1-deficient ARCI with a null TGM-1 mutation;
- Clinical diagnosis of lamellar ichthyosis;
- Age: 18 years old or older;
- Individual site IGA score of 3 to 4 at the target areas
Exclusion Criteria:
- Medical instability limiting ability to travel to the investigative center;
- Medical illness expected to complicate participation, such as an active infection with: HIV, hepatitis B (as determined by hepatitis B surface antigen screening), hepatitis C (as determined by detection of hepatitis C antibodies or a positive result of hepatitis C);
- Patient has a physical condition or other dermatological disorder (e.g., atopic, seborrheic, or contact dermatitis, psoriasis, tinea infections, etc.) which, in the Investigator's opinion, might impair evaluation of the Target Areas or which exposes the patient to unacceptable risk by study participation;
- Pregnant or breast-feeding women

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