Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis

What Was Tested

In this phase 4 trial, researchers set out to test ACTH (Corticotropin).

Acthar gel for treating the cutaneous manifestations in patients with refractory classic dermatomyositis, juvenile dermatomyositis, and amyopathic dermatomyositis.

Their hypothesis is that H.P.

It had 1 arm (groups): H.P Acthar Gel (experimental).

The registry classes the interventions as drug.

More on the Plan

Adult and juvenile dermatomyositis (DM) are systemic immune-mediated inflammatory diseases most commonly affecting the skin and musculoskeletal system.

Amyopathic dermatomyositis is a subtype of dermatomyositis that affects only the skin and lacks the characteristic muscle involvement.

Many patients have cutaneous manifestations that are refractory to numerous medications.

Acthar gel (adrenocorticotropic hormone gel) received FDA approval for treatment of a variety of diseases, including dermatomyositis, in 1952.

Who Took Part

The registry lists 19 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Must have had a skin biopsy with histologic features consistent with dermatomyositis and current cutaneous manifestations consistent with dermatomyositis. Use of topical medications and sunscreen currently and in past will be noted but not weighed for assessment of refractory cutaneous disease.

The full record lists 4 inclusion and 15 exclusion criteria; among the exclusions: patients with inflammatory myositis other than dermatomyositis, such as polymyositis or inclusion body myositis; patients with malignancy-associated dermatomyositis; patients with clear features of an overlap myositis.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the ACTH (Corticotropin) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2015-06-15 with completion listed for 2021-07-14.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Cutaneous Dermatomyositis at 6 Months (time frame: 6 months). Change in Physician's Global Assessment (PGA) Visual Acuity Score From Baseline to 6 Months (time frame: 6 months).

It also tracked 3 secondary outcomes, for example Change From Baseline in Patient Assessment of Dermatomyositis at 6 Months, Change From Baseline in Patient Global Itch Score of Dermatomyositis at 6 Months and Change From Baseline in Patient Assessment of DLQI Dermatomyositis at 6 Months.

What This Means in Plain Language

Put simply, this is a phase 4 trial of ACTH (Corticotropin) in 19 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the ACTH (Corticotropin) compound page, all human trials.