ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial
|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: NCT02348905|
Recruitment Status : Unknown
Verified January 2015 by Marc A. Judson, MD, Albany Medical College.
Recruitment status was: Not yet recruiting
First Posted : January 28, 2015
Last Update Posted : January 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Sarcoidosis Cutaneous Sarcoidosis||Drug: ACTHAR Gel 40 units twice weekly Drug: ACTHAR Gel 80 units twice weekly.||Phase 2 Phase 3|
Sarcoidosis is a multisystem granulomatous disease of unknown cause. Although sarcoidosis most commonly affects the lung3, it may affect any organ. Although corticosteroids are recognized as the drug of choice for sarcoidosis, ACTH is the only drug that is FDA-approved for this disorder. However, there is limited data on the efficacy of ACTH for this condition.
Presently, corticosteroids as considered the drug of choice for the treatment of cutaneous sarcoidosis. However, ACTHER GEL not only has obvious anti-inflammatory effects by resulting in corticosteroid production, but it may also activate melanocortin receptors. The melanocortin system has powerful anti-inflammatory properties that may be beneficial in the treatment of cutaneous sarcoidosis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||January 2016|
Experimental: ACTHAR Gel 40 units twice weekly
ACTHAR Gel at a dose of 40 units twice weekly sub cutaneous injections between Baseline and week 12.
Drug: ACTHAR Gel 40 units twice weekly
ACTHAR Gel (adrenocorticotropic hormone) 40 units twice weekly between Baseline and week 12.
Experimental: ACTHAR Gel 80 units twice weekly
ACTHAR gel at a dose of 80 units twice weekly sub cutaneous injections between Baseline and week 12.
Drug: ACTHAR Gel 80 units twice weekly.
ACTHAR Gel (adrenocorticotropic hormone) 80 units twice weekly between Baseline and week 12.
- The change in SASI induration & erythema score. [ Time Frame: Between week 0 and week 12. ]
- Photographic change [ Time Frame: Between week 0 and week 12. ]Photographic change (improved, worse, no change as determined by investigators blinded to the time of the photographs)
- SAT skin module [ Time Frame: Between week 0 and week 12. ]
- DLQI [ Time Frame: Between week 0 and week 12. ]
- Extent of granulomatous inflammation in the biopsy lesion [ Time Frame: Between week 0 and week 12. ]Extent of granulomatous inflammation in the biopsy lesion (as judged by pathologists blinded to the time of the biopsy).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348905
|Contact: Haroon Chaudhry, MBBSfirstname.lastname@example.org|
|Contact: Marc A. Judson, MD||518-262-5196|
|United States, New York|
|Albany Medical College||Not yet recruiting|
|Albany, New York, United States, 12208|
|Contact: Haroon Chaudhry, MBBS 518-262-1542 email@example.com|
|Principal Investigator: Marc A. Judson, MD|
|Principal Investigator:||Marc A Judson, MD||Albany Medical College|