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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
.
MMP-Oral-DSF Trial office
-
MMP-Oral-DSF@trials.bham.ac.uk
Dr
Saaeha
Rauz
-
swbh.eye-research@nhs.net
Mucous Membrane Pemphigoid (MMP)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Conjunctival scarring results from many diseases. These include trachoma, an infection that is known to be the largest cause of preventable blindness worldwide. It causes irreversible sight loss in both eyes in 1.9 million people worldwide. In the UK, the most common cause is a rare autoimmune-driven disorder called Ocular Mucous Membrane Pemphigoid (OcMMP) that occurs in 0.8 people per one million of the population each year. OcMMP creates chronic inflammation and scarring of the conjunctiva which lines the inside of the eyelids and covers the white of the eye. Scarring of the inside lining of the eyelid can cause the lashes to turn inwards and scratch the cornea (trichiasis). This and inflammation, lead to debilitating symptoms of constant irritation, pain, and dryness. Treatments involve immunosuppression but this has little effect on scarring. For half of patients, scar formation continues; 20% become irreversibly blind. Aldehyde Dehydrogenase (ALDH) is thought to drive this scarring process. Disulfiram is a drug given by mouth as an alcohol deterrent treatment which permanently blocks ALDH action. We would like to understand whether disulfiram has the same impact if given to patients with OcMMP. As there is no licensed disulfiram eyedrop formulation, we would like to give tablets by mouth at the UK-licensed safe dose, to patients with OcMMP for two weeks and examine how it affects the scarring signals in the conjunctiva.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Current exclusion criteria as of 27/09/2024:1. Planned surgery involving the eyelid/ conjunctiva including eyelid repair surgery, oral mucosal grafting to reconstruct fornix, or tarsorrhaphy during the course of the study (surgery can be performed after the 42-day study).2. Patients not willing to abstain or refrain from alcohol consumption 14 days pre-, during and 14 days post treatment.3. Any history of liver disease, Or alanine transaminase (ALT) >2.5x upper limit of normal, OR bilirubin >1.5x upper limit of normal at screening.4. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption5. Recent diagnosis of or unstable cardiac failure (within last 6 months)6. History of cerebrovascular accidents7. Uncontrolled hypertension8. Known coronary artery disease9. Recent admission to hospital related to poorly controlled diabetes (e.g. diabetic ketoacidosis or recurrent hypoglycaemic episodes requiring hospital attendance) within the last 6 months.10. Active seasonal allergic conjunctivitis (hay fever)11. Presence of active ophthalmic infection: bacterial, fungal or viral12. Presence of persistent infective corneal ulcers or current eye condition impacting on the study as judged by a clinician13. Known hypersensitivity to any of the components of the study or procedural medication14. History of drug, medication or alcohol abuse or addiction15. Unable to understand, speak and write the English language16. Use of any investigational agent within 4 weeks of study entry17. Participation in another investigational medicinal product (IMP) or ophthalmic interventional clinical trial at the same time as the present study18. Participant has received a live attenuated vaccine within 30 days of study entry19. Participants on an unstable dose of antidepressants or not willing to stay on the same dose throughout the study duration20. Participants on an unstable standard daily dose of inhaled steroids or not willing to stay on the same dose throughout the study duration PRN may differ but the standard daily dose prescribed must not vary).21. Participants who are not willing or able to adhere to study procedures and/or schedule22. Participants with evidence of significant acute or chronic medical or psychiatric condition including severe personality disorder, suicidal risk, psychosis, or anything that, in the judgement of the investigator, would compromise the participant’s safety or ability to complete the study.23. Participants who are currently pregnant or breast-feeding24. Females of child-bearing potential who do not agree to use a highly effective method of birth control (plus barrier methods) during heterosexual intercourse from screening until 2 days after last study treatment25. Females of childbearing potential using hormonal contraception for less than 3 months prior to study entry, or using hormonal contraception and not willing to stay on it for the duration of study26. Females taking Hormone Replacement Therapy (HRT) not willing to remain on treatment for the study duration or have started HRT within the last 3 months prior to study entry or are on an unstable dose of HRT27. Male, if not vasectomised, who does not agree to use barrier method plus a highly effective method of contraception during heterosexual intercourse from screening through to 2 days after the last dose of study treatment.
Previous exclusion criteria:1. Planned surgery involving the eyelid/ conjunctiva including eyelid repair surgery, oral mucosal grafting to reconstruct fornix, or tarsorrhaphy during the course of the study (surgery can be performed after the 42-day study).2. Patients not willing to abstain or refrain from alcohol consumption 14 days pre-, during and 14 days post treatment.3. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption4. Recent diagnosis of or unstable cardiac failure (within last 6 months)5. Recent diagnosis of Cerebrovascular accidents (within last 6 months)6. Recent hypertensive crisis or diagnosis of malignant hypertension (within last 6 months)7. Unstable coronary artery disease (within the last 6 months)8. Recent admission to hospital related to poorly controlled diabetes (e.g. diabetic ketoacidosis or recurrent hypoglycaemic episodes requiring hospital attendance) within the last 6 months9. Active seasonal allergic conjunctivitis (hay fever)10. Presence of active ophthalmic infection: bacterial, fungal or viral11. Presence of persistent infective corneal ulcers or current eye condition impacting on the study as judged by a clinician12. Known hypersensitivity to any of the components of the study or procedural medication13. History of drug, medication or alcohol abuse or addiction14. Unable to understand, speak and write the English language15. Use of any investigational agent within 4 weeks of study entry16. Participation in another investigational medicinal product (IMP) or ophthalmic interventional clinical trial at the same time as the present study17. Participant has received a live attenuated vaccine within 30 days of study entry18. Participants on an unstable dose of antidepressants or not willing to stay on the same dose throughout the study duration19. Participants on an unstable standard daily dose of inhaled steroids or not willing to stay on the same dose throughout the study duration PRN may differ but the standard daily dose prescribed must not vary).20. Participants who are not willing or able to adhere to study procedures and/or schedule21. Participants with evidence of significant acute or chronic medical or psychiatric condition that, in the judgement of the investigator, would compromise the participant’s safety or ability to complete the study22. Participants who are currently pregnant or breast-feeding23. A woman of child-bearing potential (WOCBP) who does not agree to use a method of birth control (including barrier methods) during heterosexual intercourse from screening until 1 day after last study treatment24. Females of childbearing potential using hormonal contraception for less than 3 months prior to study entry, or using hormonal contraception and not willing to stay on it for the duration of study 25. Females taking Hormone Replacement Therapy (HRT) not willing to remain on treatment for the study duration or have started HRT within the last 3 months prior to study entry or are on an unstable dose of HRT26. Male, if not vasectomised, who does not agree to use barrier contraception (condom) during heterosexual intercourse from screening through to 1 day after the last dose of study treatment.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
.
MMP-Oral-DSF Trial office
-
MMP-Oral-DSF@trials.bham.ac.uk
Dr
Saaeha
Rauz
-
swbh.eye-research@nhs.net
The study is sponsored by University of Birmingham and funded by Medical Research Council.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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