ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial

Status unconfirmed · Phase 2/Phase 3

Conditions studied: Sarcoidosis, Cutaneous Sarcoidosis

In brief

ACTHAR gel has efficacy in the treatment of cutaneous sarcoidosis

Key facts

Study ID

NCT02348905

Run by

Albany Medical College

People needed

10

Starts

2015-03-01

Expected to finish

2016-01-01

Last updated by the study team

2015-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have biopsy-proven sarcoidosis.
• 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.
• Both lesions must have a SASI induration score of > 1 and a SASI induration + erythema score of > 2.
• 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.
• If a subject has only lupus pernio facial lesions, one needs to be at least 0.5 cm in diameter.

You may not qualify if…

• Previous toxic or allergic reaction to ACTHAR gel
• The presence of another skin condition in addition to sarcoidosis that would interfere with the assessment of the sarcoidosis skin lesions.
• Uncontrolled hypertension.
• Uncontrolled diabetes.
• Active infection.
• A medical condition that, in the opinion of the investigator would place the subject at significant risk by administering ACTHAR gel.

Where it is running

• Albany Medical College — Albany, New York, United States

Full record on ClinicalTrials.gov

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