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

Study Overview
=================
Brief Summary
-----------------
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Acetonide every week until no further improvement of the lesion occurred (stage I) then the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II).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 as no further improvement is gained, the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II) at this stage the patients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

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

Conditions
-----------------
Benign Mucous Membrane Pemphigoid

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
Eligibility Criteria
-----------------
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 -

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: effect of large dose corticosteroids with intra-lestional injection in treatment of MMP<br>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) | 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<br>* 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).<br>|
| Experimental: effect of of (MMF), dapsone and cortisone in treatment of MMP<br>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). | 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<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |