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ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial

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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
Sponsor:
Information provided by (Responsible Party):
Marc A. Judson, MD, Albany Medical College

Brief Summary:
ACTHAR gel has efficacy in the treatment of cutaneous sarcoidosis

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

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. The change in SASI induration & erythema score. [ Time Frame: Between week 0 and week 12. ]

Secondary Outcome Measures :
  1. 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)

  2. SAT skin module [ Time Frame: Between week 0 and week 12. ]
  3. DLQI [ Time Frame: Between week 0 and week 12. ]
  4. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Haroon Chaudhry, MBBS 518-262-1542 chaudhh@mail.amc.edu
Contact: Marc A. Judson, MD 518-262-5196

Locations
United States, New York
Albany Medical College Not yet recruiting
Albany, New York, United States, 12208
Contact: Haroon Chaudhry, MBBS    518-262-1542    chaudhh@mail.amc.edu   
Principal Investigator: Marc A. Judson, MD         
Sponsors and Collaborators
Albany Medical College
Investigators
Principal Investigator: Marc A Judson, MD Albany Medical College

Responsible Party: Marc A. Judson, MD, Albany Medical College
ClinicalTrials.gov Identifier: NCT02348905     History of Changes
Other Study ID Numbers: AMCMAJCUT2014
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Adrenocorticotropic Hormone
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Melanocyte-Stimulating Hormones
beta-Endorphin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action