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Impact of Acthar on Everyday Life of Participants With Severe Keratitis
Plain-language guide to NCT04169061: phase 4 interventional trial of ACTH (Corticotropin), 36 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04169061
- Phase
- phase 4
- Status
- completed
- Start
- 2019-11-13
- Completion (planned or actual)
- 2020-11-09
- Participants
- 36 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Keratitis
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around ACTH (Corticotropin).
The researchers will need about 36 participants for this study.
It had 1 arm (groups): All participants (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 36 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: Has severe or recalcitrant keratitis. Did not respond to, or tolerate, treatment with topical cyclosporine, Lifitegrast, or any immunosuppressant to treat keratitis. Has normal eyelids, and protocol-defined physical and medical eye attributes. Agrees to avoid wearing contact lenses during the trial.
The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: is pregnant or breast-feeding; is defined as vulnerable, or is employed by, or related to anyone involved in the study; has a medical condition or history that might, per protocol or in the opinion of the investigator, compromise the participant's safety or study analysis.
How the Study Was Run
The set-up was single-group and open-label.
Everyone knew when ACTH (Corticotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2019-11-13 with completion listed for 2020-11-09.
It ran at 9 sites in United States (9).
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 4 trial of ACTH (Corticotropin) in 36 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.
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.