Benign Mucous Membrane PemphigoidPhase 2/3NCT04744623
Clinical Evaluation of New Treatment Strategy of Mucous Membrane Pemphigoid Using Large Dose of Prednisolone Plus Intra-lesional of Triamcinolone Acetonide Followed by Combination of Mycophenolate Mofetil, Dapsone and Low Dose Prednisolone
A Phase 2/3 study testing large dose of prednisolone plus intra-lesional of Triamcinolone Acetonide followed the systemic combination of mycophenolate mofetil (MMF), dapsone and low dose prednisolone in treatment of MMP in people with Benign Mucous Membrane Pemphigoid, run by Tanta University at 1 site in Egypt.
Trial summary
Abstract: Mucous membrane pemphigoid (MMP) is an autoimmune blistering disorder characterized by inflammation, blistering, and scarring and predominantly occurring at mucous membranes. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Benign Mucous Membrane Pemphigoid
- What is being tested?
- large dose of prednisolone plus intra-lesional of Triamcinolone Acetonide followed the systemic combination of mycophenolate mofetil (MMF), dapsone and low dose prednisolone in treatment of MMP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2020to 4 Nov 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with age references patients confirmed from dermatology department that they had mucous membrane(MMP) pemphigoid- patients are not allergic o to the drugs being used for the treatment
Who cannot join
- patients below or above age reference used in the study patients with other oral lesions not being confirmed as MMP patients with systemic diseases preventing using of the drugs
- -
Trial locations and contacts
1 site in 1 country.
About this study
Abstract: Mucous membrane pemphigoid (MMP) is an autoimmune blistering disorder characterized by inflammation, blistering, and scarring and predominantly occurring at mucous membranes. Successful treatment can be challenging, and uncontrolled disease may result in significant morbidity with scarring of the conjunctiva and oropharynx leading to blindness and dysphagia. Therefore successful treatment is a must to improve patient quality of life.
Aim of work: to evaluate clinically the effectiveness of systemic large dose of prednisolone plus intra-lesional of Triamcinolone Acetonide followed the systemic combination of mycophenolate mofetil (MMF), dapsone and low dose prednisolone in treatment of MMP cases.
Materials and method: 10 patients suffering from MMP were selected after complete diagnosis based on their clinical diagnosis and immunopathologic findings of IgG, IgA, and/or C3 targeting skin basement membranes with a linear deposition pattern refered from dermatology department. These patient were treated using large dose of prednisone 60mg daily plus intrational injection of Triamcinolone Acetonide every week until no further improvement of the lesion occurred (stage I) then the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II). The lesion size and pain score will be assessed before treatment and during treatment in stage I and stage II. These data will be tabulated and statistically analyzed
Read the detailed description
Before starting any treatment the size of the lesion will be measured and pain score will be evaluated. then patient were treated using large dose of prednisone 60mg daily plus intra-lesional injection of Triamcinolone Acetonide every week until no further improvement of the lesion occurred (stage I) at this stage the patients pain would be evaluated and lesion size would be measured .
as no further improvement is gained, the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II) at this stage the patients pain would be evaluated and lesion size would be measured. then the data will be tabulated and statistically analyzed regarding pain score and lesion size
- Conditions
- Benign Mucous Membrane Pemphigoid
- Being tested
- large dose of prednisolone plus intra-lesional of Triamcinolone Acetonide followed the systemic combination of mycophenolate mofetil (MMF), dapsone and low dose prednisolone in treatment of MMP
- Medical subject headings
- Pemphigoid, Benign Mucous Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
large dose of prednisolone plus intra-lesional of Triamcinolone Acetonide followed the systemic combination of mycophenolate mofetil (MMF), dapsone and low dose prednisolone in treatment of MMPDrug
10 patients suffering from MMP were selected after complete diagnosis based on their clinical diagnosis and immunopathologic findings of IgG, IgA, and/or C3 targeting skin basement membranes with a linear deposition pattern refered from dermatology department. These patient were treated using large dose of prednisone 60mg daily plus intrational injection of Triamcinolone Acetonide every week until no further improvement of the lesion occurred (stage I) then the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II).
| Study group | Role | What they receive |
|---|---|---|
| effect of large dose corticosteroids with intra-lestional injection in treatment of MMP | Experimental | 10 patients suffering from MMP were selected referred from dermatology department. These patient were treated using large dose of prednisone 60mg daily plus intra-lesion injection of Triamcinolone Acetonide every week until no further improvement of the lesion occurred (stage I) Receives: Drug: large dose of prednisolone plus intra-lesional of Triamcinolone Acetonide followed the systemic combination of mycophenolate mofetil (MMF), dapsone and low dose prednisolone in treatment of MMP |
| effect of of (MMF), dapsone and cortisone in treatment of MMP | Experimental | 10 patients suffering from MMP were selected referred from dermatology department. These patient were treated using large dose of prednisone 60mg daily plus intra-lesion injection of Triamcinolone Acetonide every week until no further improvement of the lesion occurred (stage I) then the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II). Receives: Drug: large dose of prednisolone plus intra-lesional of Triamcinolone Acetonide followed the systemic combination of mycophenolate mofetil (MMF), dapsone and low dose prednisolone in treatment of MMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mycophenolate mofetil, dapsone and low dose prednisolone may showing powerful effect than large dose of systemic corticosteroids with intra-lestional corticosteroid in treatment of Mucous membrane pemphigoid
10 patients suffering from MMP were selected after complete diagnosis based on their clinical diagnosis and immunopathologic findings of IgG, IgA, and/or C3 targeting skin basement membranes with a linear deposition pattern refered from dermatology department. These patient were treated using large dose of prednisone 60mg daily plus intrational injection of Triamcinolone Acetonide every week until no further improvement of the lesion occurred (stage I) then the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II).
Measured: from 10-11 months
Secondary outcomes (1)
No difference in the effectiveness between large dose of prednisone with intra-lesional versus Mycophenolate mofetil, dapsone and low dose prednisolone
10 patients suffering from MMP were selected after complete diagnosis based on their clinical diagnosis and immunopathologic findings of IgG, IgA, and/or C3 targeting skin basement membranes with a linear deposition pattern refered from dermatology department. These patient were treated using large dose of prednisone 60mg daily plus intrational injection of Triamcinolone Acetonide every week until no further improvement of the lesion occurred (stage I) then the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II).
Measured: from 10-11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start30 Sep 2020
- Primary completion1 Dec 2020
- Study completion4 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Mucous Membrane PemphigoidStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 10 patients suffering from MMP were selected after complete diagnosis based on their clinical diagnosis and immunopathologic findings of IgG, IgA, and/or C3 targeting skin basement membranes with a linear deposition pattern referred from dermatology department. These patient were treated using large dose of prednisone 60mg daily plus intrational injection of Triamcinolone Acetonide every week until no further improvement of the lesion occurred (stage I) then the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II). The lesion size and pain score will be assessed before treatment and during treatment in stage I and stage II. These data will be tabulated and statistically analyzed
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehab ghouraba, Tanta University
- Investigators
- rehab f ghouraba, PHD, Principal investigator, Tanta university, faculty of dentistry, Oral medicine clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744623
- Sponsor's protocol ID
- 111
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of New Treatment Strategy of Mucous Membrane Pemphigoid Using Large Dose of Prednisolone Plus Intra-lesional of Triamcinolone Acetonide Followed by Combination of Mycophenolate Mofetil, Dapsone and Low Dose Prednisolone
- ClinicalTrials.gov ID
- NCT04744623
- Acronym / sponsor ID
- 111
- Conditions
- Benign Mucous Membrane Pemphigoid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 4 Nov 2021 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Abstract: Mucous membrane pemphigoid (MMP) is an autoimmune blistering disorder characterized by inflammation, blistering, and scarring and predominantly occurring at mucous membranes. Successful treatment can be challenging, and uncontrolled disease may result in significant morbidity with scarring of the conjunctiva and oropharynx leading to blindness and dysphagia. Therefore successful treatment is a must to improve patient quality of life.
Aim of work: to evaluate clinically the effectiveness of systemic large dose of prednisolone plus intra-lesional of Triamcinolone Acetonide followed the systemic combination of mycophenolate mofetil (MMF), dapsone and low dose prednisolone in treatment of MMP cases.
Materials and method: 10 patients suffering from MMP were selected after complete diagnosis based on their clinical diagnosis and immunopathologic findings of IgG, IgA, and/or C3 targeting skin basement membranes with a linear deposition pattern refered from dermatology department. These patient were treated using large dose of prednisone 60mg daily plus intrational injection of Triamcinolone Acetonide every week until no further improvement of the lesion occurred (stage I) then the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II). The lesion size and pain score will be assessed before treatment and during treatment in stage I and stage II. These data will be tabulated and statistically analyzed
Detailed description
Before starting any treatment the size of the lesion will be measured and pain score will be evaluated. then patient were treated using large dose of prednisone 60mg daily plus intra-lesional injection of Triamcinolone Acetonide every week until no further improvement of the lesion occurred (stage I) at this stage the patients pain would be evaluated and lesion size would be measured .
as no further improvement is gained, the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II) at this stage the patients pain would be evaluated and lesion size would be measured. then the data will be tabulated and statistically analyzed regarding pain score and lesion size
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 10 patients suffering from MMP were selected after complete diagnosis based on their clinical diagnosis and immunopathologic findings of IgG, IgA, and/or C3 targeting skin basement membranes with a linear deposition pattern referred from dermatology department. These patient were treated using large dose of prednisone 60mg daily plus intrational injection of Triamcinolone Acetonide every week until no further improvement of the lesion occurred (stage I) then the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II). The lesion size and pain score will be assessed before treatment and during treatment in stage I and stage II. These data will be tabulated and statistically analyzed
| Arm | Type | Receives |
|---|---|---|
| effect of large dose corticosteroids with intra-lestional injection in treatment of MMP | Experimental | Drug: large dose of prednisolone plus intra-lesional of Triamcinolone Acetonide followed the systemic combination of mycophenolate mofetil (MMF), dapsone and low dose prednisolone in treatment of MMP10 patients suffering from MMP were selected referred from dermatology department. These patient were treated using large dose of prednisone 60mg daily plus intra-lesion injection of Triamcinolone Acetonide every week until no further improvement of the lesion occurred (stage I) |
| effect of of (MMF), dapsone and cortisone in treatment of MMP | Experimental | Drug: large dose of prednisolone plus intra-lesional of Triamcinolone Acetonide followed the systemic combination of mycophenolate mofetil (MMF), dapsone and low dose prednisolone in treatment of MMP10 patients suffering from MMP were selected referred from dermatology department. These patient were treated using large dose of prednisone 60mg daily plus intra-lesion injection of Triamcinolone Acetonide every week until no further improvement of the lesion occurred (stage I) then the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II). |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with age references patients confirmed from dermatology department that they had mucous membrane(MMP) pemphigoid- patients are not allergic o to the drugs being used for the treatment
Key exclusion criteria (2 listed)
- patients below or above age reference used in the study patients with other oral lesions not being confirmed as MMP patients with systemic diseases preventing using of the drugs
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| large dose of prednisolone plus intra-lesional of Triamcinolone Acetonide followed the systemic combination of mycophenolate mofetil (MMF), dapsone and low dose prednisolone in treatment of MMP10 patients suffering from MMP were selected after complete diagnosis based on their clinical diagnosis and immunopathologic findings of IgG, IgA, and/or C3 targeting skin basement membranes with a linear deposition pattern refered from dermatology department. These patient were treated using large dose of prednisone 60mg daily plus intrational injection of Triamcinolone Acetonide every week until no further improvement of the lesion occurred (stage I) then the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II). | Drug | effect of large dose corticosteroids with intra-lestional injection in treatment of MMP, effect of of (MMF), dapsone and cortisone in treatment of MMP |
Primary outcome
Mycophenolate mofetil, dapsone and low dose prednisolone may showing powerful effect than large dose of systemic corticosteroids with intra-lestional corticosteroid in treatment of Mucous membrane pemphigoid
Time frame: from 10-11 months
10 patients suffering from MMP were selected after complete diagnosis based on their clinical diagnosis and immunopathologic findings of IgG, IgA, and/or C3 targeting skin basement membranes with a linear deposition pattern refered from dermatology department. These patient were treated using large dose of prednisone 60mg daily plus intrational injection of Triamcinolone Acetonide every week until no further improvement of the lesion occurred (stage I) then the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II).
1 secondary outcome
No difference in the effectiveness between large dose of prednisone with intra-lesional versus Mycophenolate mofetil, dapsone and low dose prednisolone
Time frame: from 10-11 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
rehab f ghouraba, PHD principal investigator
Tanta university, faculty of dentistry, Oral medicine clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing large dose of prednisolone plus intra-lesional of Triamcinolone Acetonide followed the systemic combination of mycophenolate mofetil (MMF), dapsone and low dose prednisolone in treatment of MMP in people with Benign Mucous Membrane Pemphigoid, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mycophenolate mofetil, dapsone and low dose prednisolone may showing powerful effect than large dose of systemic corticosteroids with intra-lestional corticosteroid in treatment of Mucous membrane pemphigoid (time frame: from 10-11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.