Gentamicin for RDEB
![]() |
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. |
ClinicalTrials.gov Identifier: NCT03012191 |
Recruitment Status :
Completed
First Posted : January 6, 2017
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
|
Sponsor:
University of Southern California
Information provided by (Responsible Party):
David Woodley, University of Southern California
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Recessive Dystrophic Epidermolysis Bullosa |
Intervention |
Drug: Gentamicin Sulfate |
Enrollment | 6 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Topical Gentamicin | Intravenous Gentamicin | Intradermal Gentamicin |
---|---|---|---|
![]() |
0.5% Gentamicin ointment | IV gentamicin is prepared to 7.5 mg/kg body weight and administered over a 30 minutes. | 0.5% Gentamicin ointment applied after microneedle roller assistance |
Period Title: Overall Study | |||
Started | 2 | 2 | 2 |
Completed | 2 | 2 | 2 |
Not Completed | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Topical Gentamicin | Intravenous Gentamicin | Intradermal Gentamicin | Total | |
---|---|---|---|---|---|
![]() |
0.5% Gentamicin ointment | IV gentamicin is prepared to 7.5 mg/kg body weight and administered over a 30 minutes. | 0.5% Gentamicin ointment applied after microneedle roller assistance | Total of all reporting groups | |
Overall Number of Baseline Participants | 2 | 2 | 2 | 6 | |
![]() |
[Not Specified]
|
||||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 2 participants | 2 participants | 2 participants | 6 participants | |
<=18 years |
2 100.0%
|
0 0.0%
|
1 50.0%
|
3 50.0%
|
|
Between 18 and 65 years |
0 0.0%
|
2 100.0%
|
1 50.0%
|
3 50.0%
|
|
>=65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Age, Continuous
Mean (Full Range) Unit of measure: Years |
|||||
Number Analyzed | 2 participants | 2 participants | 2 participants | 6 participants | |
9
(1 to 17)
|
28.5
(27 to 30)
|
22
(17 to 27)
|
19.8
(1 to 30)
|
||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 2 participants | 2 participants | 2 participants | 6 participants | |
Female |
0 0.0%
|
1 50.0%
|
1 50.0%
|
2 33.3%
|
|
Male |
2 100.0%
|
1 50.0%
|
1 50.0%
|
4 66.7%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 2 participants | 2 participants | 2 participants | 6 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
White |
2 100.0%
|
2 100.0%
|
2 100.0%
|
6 100.0%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
|||||
United States | Number Analyzed | 2 participants | 2 participants | 2 participants | 6 participants |
2 | 2 | 2 | 6 | ||
Expression of C7 in Skin
Mean (Full Range) Unit of measure: C7 Expression (percent of normal skin) |
|||||
Number Analyzed | 2 participants | 2 participants | 2 participants | 6 participants | |
0
(0 to 0)
|
6.8
(2 to 11.6)
|
5.8
(0 to 11.6)
|
4.2
(0 to 11.6)
|
||
Presence of Anchoring Fibrils in Skin
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 2 participants | 2 participants | 2 participants | 6 participants | |
0 0.0%
|
1 50.0%
|
1 50.0%
|
2 33.3%
|
Outcome Measures
Adverse Events
Limitations and Caveats
Small number of subjects analyzed due to rarity of the disease and experimental plan.
More Information
Results Point of Contact
Name/Title: | Dr. David Woodley |
Organization: | University of Southern California Department of Dermatology |
Phone: | (323)442-0084 |
EMail: | dwoodley@med.usc.edu |
Responsible Party: | David Woodley, University of Southern California |
ClinicalTrials.gov Identifier: | NCT03012191 |
Other Study ID Numbers: |
HS-16-00788 |
First Submitted: | January 4, 2017 |
First Posted: | January 6, 2017 |
Results First Submitted: | June 3, 2019 |
Results First Posted: | July 23, 2019 |
Last Update Posted: | July 23, 2019 |