Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04663906 |
| Other study ID # |
1/095/20 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2021 |
| Est. completion date |
May 31, 2021 |
Study information
| Verified date |
December 2020 |
| Source |
University of Aberdeen |
| Contact |
Louise King |
| Email |
researchgovernance[@]abdn.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
There is a theoretical risk that the nasal mucosal dryness caused by oral retinoid
medications may increase the risk of patients becoming infected with Covid-19.
Isotretinoin is a drug used commonly in dermatology, usually for management of acne and
occasionally for management of other dermatological diseases. The most common side effect of
oral isotretinoin is mucocutaneous dryness, which can lead to nasal dryness and crusting.
Isotretinoin is derived from vitamin A and produces this side effect by arresting the cell
cycle of mucus secreting cells in the nasal cavity. The mucus usually secreted moisturises
the nasal cavity and provides a protective, lubricating layer overlying the cilia.
Cilia and nasal mucous are both believed to have roles in defence against infection and
immunity. Hence it was postulated at the start of the pandemic that the effect this
medication has on the nasal environment may increase the likelihood of contracting a disease
spread by droplet or aerosol particles.
In March 2020 we established a departmental Excel database of our patients on oral retinoid
medications in order to track those currently receiving treatment.
The database includes people taking isotretinoin, alitretinoin and acitretin. The greatest
number of patients in this database are in the isotretinoin group and patients taking
isotretinoin tend to be a relatively young and fit population. Acitretin on the other hand is
often used in an older population who may have other underlying disease comorbidities. There
were only a very small number of patients taking alitretinoin in the database.
In order to limit confounding variables and provide as clear a result as possible, it was
decided to limit this study to comparing the group of patients taking isotretinoin, aged
16-40years, with an age-matched background population from NHS Grampian.
This study would examine the electronic patient record of patients aged 16-40years, taking
isotretinoin between March and October 2020 and compare their rates of Covid-19 infection,
hospitalisation and complications with the rates of the local age-matched background
population. Persons taking isotretinoin in the time period would be excluded from the
background population.
As Covid-19 is a new disease, the existing research literature on this specific topic is
extremely limited, and so far this study would be the first in this area.
Description:
Isotretinoin is a drug used commonly in dermatology, usually for management of acne and
occasionally for management of other dermatological diseases. The most common side effect of
oral isotretinoin is mucocutaneous dryness, which can lead to nasal dryness and crusting.
Isotretinoin is derived from vitamin A and produces this side effect by arresting the cell
cycle of mucus secreting cells in the nasal cavity. The mucus usually secreted moisturises
the nasal cavity and provides a protective, lubricating layer overlying the cilia.
Cilia and nasal mucous are both believed to have roles in defence against infection and
immunity. Hence it was postulated at the start of the pandemic that the effect this
medication has on the nasal environment may increase the likelihood of contracting a disease
spread by droplet or aerosol particles, such as Covid-19.
In March 2020 we established a departmental database of our patients on oral retinoid
medications in order to track those currently receiving treatment. The database includes
people taking isotretinoin, alitretinoin and acitretin. The greatest number of patients in
this database are in the isotretinoin group and patients taking isotretinoin tend to be a
relatively young and fit population. Acitretin on the other hand is often used in an older
population who may have other underlying disease comorbidities. There were only a very small
number of patients taking alitretinoin in the database.
In order to limit confounding variables and provide as clear a result as possible, it was
decided to limit this study to comparing the group of patients taking isotretinoin, aged
16-40years, with an age-matched background population from NHS Grampian.
This study would examine the electronic patient record of patients aged 16-40years, taking
isotretinoin between March and October 2020 and compare their rates of Covid-19 infection,
hospitalisation and complications with the rates of the local age-matched background
population. Persons taking isotretinoin in the time period would be excluded from the
background population.
As Covid-19 is a new disease, the existing research literature on this specific topic is
extremely limited, and so far this study would be the first in this area.
The electronic patient record of patients aged 16-40years taking isotretinoin between March
and October 2020 will be accessed and the following will be recorded:
- Covid-19 testing while on or within 4 weeks after treatment
- Positive Covid-19 test while on or within 4 weeks after treatment
- Hospitalisation with Covid-19 while on or within 4 weeks after treatment
- ICU admission while on or within 4 weeks of treatment
- Death directly attributed to Covid-19 while on or within 4 weeks of treatment. The data
held in the database is identifiable and held on the NHS Grampian secure server.
Once the details above are filled in each case will be anonymised with a case number. A key
linking this back to the CHI will be kept on the NHS Grampian secure server.
Further data analysis will be completed using the anonymised data.
Details of an age matched local population can be obtained from Health Intelligence pending
R&D approval of this study.
The University of Aberdeen department of medical statistics have already been consulted about
this project and are willing to offer their help with data analysis. Once statistical
analysis has been decided upon we will update the protocol or submit the details as an
amendment, before analysis takes place.
