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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

Primary Purpose

Benign Mucous Membrane Pemphigoid

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
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
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Mucous Membrane Pemphigoid

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • Rehab Fouad Ghouraba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

effect of large dose corticosteroids with intra-lestional injection in treatment of MMP

effect of of (MMF), dapsone and cortisone in treatment of MMP

Arm Description

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)

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Acetonide every week until no further improvement of the lesion occurred (stage I) then the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
February 2, 2021
Last Updated
February 4, 2021
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04744623
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
November 4, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Mucous Membrane Pemphigoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
effect of large dose corticosteroids with intra-lestional injection in treatment of MMP
Arm Type
Experimental
Arm Description
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)
Arm Title
effect of of (MMF), dapsone and cortisone in treatment of MMP
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
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
Intervention 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 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).
Primary Outcome Measure Information:
Title
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
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 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).
Time Frame
from 10-11 months
Secondary Outcome Measure Information:
Title
No difference in the effectiveness between large dose of prednisone with intra-lesional versus Mycophenolate mofetil, dapsone and low dose prednisolone
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 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).
Time Frame
from 10-11 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
rehab f ghouraba, PHD
Organizational Affiliation
Tanta university, faculty of dentistry, Oral medicine clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehab Fouad Ghouraba
City
Tanta
State/Province
Grabia
ZIP/Postal Code
3111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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