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Repository Corticotropin Injection in Keratoconjunctivitis Sicca
Plain-language guide to NCT03398018: phase 4 interventional trial of ACTH (Corticotropin). Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03398018
- Phase
- phase 4
- Status
- withdrawn
- Start
- 2018-11-01
- Completion (planned or actual)
- 2018-11-01
- Participants
- n/a (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Keratoconjunctivitis Sicca
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested ACTH (Corticotropin).
The purpose of this pilot study is to assess repository corticotropin injection (RCI) in the form of H.P.
Acthar Gel in patients with severe keratoconjunctivitis sicca (KCS, or dry eye disease).
It had 1 arm (groups): Treatment (experimental).
Treated with repository corticotropin injection.
The registry classes the interventions as drug.
More on the Plan
This study is a non-randomized, open-label, interventional pilot study with sixteen weeks (112 days) of active treatment, a possible twelve-week treatment extension, and twenty-four weeks of washout follow-up.
Data will be collected from five subjects.
Who 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: Age ≥ 18 years.
The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: any corticosteroid use within 60 days of study enrollment; recent surgery within 90 days; current uncontrolled, sustained hypertension.
How the Study Was Run
Design: 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 2018-11-01 with completion listed for 2018-11-01.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Conjunctival hyperemia (time frame: 16 weeks). Corneal staining (time frame: 16 weeks).
It also tracked 2 secondary outcomes, for example Patient symptoms and Tear cytokine concentration.
What This Means in Plain Language
Put simply, this is a phase 4 trial of ACTH (Corticotropin) in people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the ACTH (Corticotropin) compound page, all human trials.
Our Notes on the Compound
ACTH (Corticotropin): The 39-amino-acid pituitary hormone that drives cortisol production; given as repository corticotropin (Acthar Gel).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.