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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02348905 |
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Date of registration:
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20/06/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial
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Scientific title:
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ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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10 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02348905 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Haroon Chaudhry, MBBS |
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Address:
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Telephone:
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518-262-1542 |
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Email:
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chaudhh@mail.amc.edu |
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Affiliation:
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Name:
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Marc A Judson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Albany Medical College |
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Name:
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Haroon Chaudhry, MBBS |
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Address:
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Telephone:
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518-262-1542 |
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Email:
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chaudhh@mail.amc.edu |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients must have biopsy-proven sarcoidosis.
2. a) Patients with active cutaneous sarcoidosis and two active lesions on stable
therapy or no therapy for at least two months AND/OR b) Patients with active
cutaneous sarcoidosis and lupus pernio lesions on stable therapy or no therapy for at
least two months. A maximum of 5 patients may be enrolled fulfilling criterion b)
above.
3. Both lesions must have a SASI induration score of > 1 and a SASI induration +
erythema score of > 2.
4. If two lesions are present, one must be > 1cm in diameter and the subject must be
willing to have it biopsied. The second lesion must be at least 0.5 cm in diameter.
5. If a subject has only lupus pernio facial lesions, one needs to be at least 0.5 cm in
diameter.
Exclusion Criteria:
1. Previous toxic or allergic reaction to ACTHAR gel
2. The presence of another skin condition in addition to sarcoidosis that would
interfere with the assessment of the sarcoidosis skin lesions.
3. Uncontrolled hypertension.
4. Uncontrolled diabetes.
5. Active infection.
6. A medical condition that, in the opinion of the investigator would place the subject
at significant risk by administering ACTHAR gel.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cutaneous Sarcoidosis
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Sarcoidosis
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Intervention(s)
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Drug: ACTHAR Gel 40 units twice weekly
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Drug: ACTHAR Gel 80 units twice weekly.
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Primary Outcome(s)
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The change in SASI induration & erythema score.
[Time Frame: Between week 0 and week 12.]
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Secondary Outcome(s)
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DLQI
[Time Frame: Between week 0 and week 12.]
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Photographic change
[Time Frame: Between week 0 and week 12.]
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Extent of granulomatous inflammation in the biopsy lesion
[Time Frame: Between week 0 and week 12.]
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SAT skin module
[Time Frame: Between week 0 and week 12.]
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Secondary ID(s)
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AMCMAJCUT2014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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