ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial

• Status: Unknown status
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

ACTHAR gel has efficacy in the treatment of cutaneous sarcoidosis

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albany Medical College
• Treatments: Adrenocorticotropic Hormone; beta-Endorphin; Melanocyte-Stimulating Hormones

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.