Benign Mucous Membrane Pemphigoid Clinical Trial
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
| Verified date | February 2021 |
| Source | Tanta University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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Acetonide every week until no further improvement of the lesion occurred (stage I) then the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II).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
| Status | Active, not recruiting |
| Enrollment | 10 |
| Est. completion date | November 4, 2021 |
| Est. primary completion date | December 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 60 Years |
| Eligibility | Inclusion Criteria: 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 Exclusion Criteria: 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 - |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Rehab Fouad Ghouraba | Tanta | Grabia |
| Lead Sponsor | Collaborator |
|---|---|
| Tanta University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | from 10-11 months | |
| Secondary | 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). | from 10-11 months |