Clinical trial NCT02348905: ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial
Official title: ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Sarcoidosis
Cutaneous Sarcoidosis
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: The change in SASI induration & erythema score.
timeFrame: Between week 0 and week 12.
Secondary outcomes:
measure: Photographic change
timeFrame: Between week 0 and week 12.
measure: SAT skin module
timeFrame: Between week 0 and week 12.
measure: DLQI
timeFrame: Between week 0 and week 12.
measure: Extent of granulomatous inflammation in the biopsy lesion
timeFrame: Between week 0 and week 12.
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical College
state: New York
Study officials:
affiliation: Albany Medical College
name: Marc A Judson, MD
role: PRINCIPAL_INVESTIGATOR
References: