NCT02348905

ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Albany Medical College · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

ACTHAR gel has efficacy in the treatment of cutaneous sarcoidosis

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.

Conditions

• Sarcoidosis
• Cutaneous Sarcoidosis

Interventions

Type	Name	Description
DRUG	ACTHAR Gel 40 units twice weekly	ACTHAR Gel (adrenocorticotropic hormone) 40 units twice weekly 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.

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-07-01
• Completion: 2016-01-01
• First posted: 2015-01-28
• Last updated: 2015-01-28

Locations

1 site across 1 country: United States