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Rare Benign Lesion of Peins

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04725292
Recruitment Status : Completed
First Posted : January 26, 2021
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Abdelrahman Mohamed Abdelkader, Assiut University

Brief Summary:
PEKMB was first named and described by Lortat-Jacob & Civatte in 1961 and by Bart & Kopf later. This rare condition is mostly reported in elderly males. The keratotic scales is usually micaceous and resembles psoriasis. Most patients are above 50 years of age and are circumcised later in life, but also reported in younger age group. This mica like scales contains keratin which gets dissolved in 10% potassium hydroxide solution. Disease progression may lead to phimosis. Differential diagnosis of this disease entity include moniliasis, wart, psoriasis ,penile horn, circinate balanitis, erythroplasia of Queyrat, squamous cell epithelioma and verrucous carcinoma. It is primarily a benign entity, it is capable of invasiveness. Bart and Kopf considered it to be in intermediate stage between benign hyperplasia and squamous cell carcinoma. However, the histological spectrum can range from hypertrophic-hyperplastic penile dystrophy to verrucous carcinoma. Fibro sarcoma has been reported developing in a same patient. Etiology is unclear. Despite search for a viral agent, Human Papilloma Virus (HPV) has not been demonstrated and its role in pathogenesis or its transformation to verrucous carcinoma has been proved. The treatment of PEKMB should be conservative when there is no histological evidence of malignancy. All such patients should be followed up. Treatment choices include potent topical steroids, topical 5% 5-flurouracil cream1, 2, cryotherapy, radiotherapy and shaving biopsy plus electro coagulation. When frank malignancy is observed, excision with wide margin is the rule.

Condition or disease
Skin Diseases Penile Diseases

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Other
Time Perspective: Other
Official Title: Pseudoepitheliomatous Hyperplasia of the Penis a Very Rare Disease in Egypt
Actual Study Start Date : January 12, 2021
Actual Primary Completion Date : January 12, 2021
Actual Study Completion Date : January 12, 2021



Primary Outcome Measures :
  1. improvement of the skin lesion [ Time Frame: 1 month after treatment ]
    drugs will be given to patient then the effect ,either improvement or worsening will be noticied

  2. improvement of associated lesion [ Time Frame: 1 month after drug given ]
    patient complained of difficulty and burning micturition which will be seen after treatment



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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   case report
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
male healthy married
Criteria

Inclusion Criteria:

  • 40 years
  • failed medical treatment

Exclusion Criteria:

  • psoriasis
  • allergy
  • trauma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725292


Locations
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Egypt
Assuit Medical School
Assiut, Assuit, Egypt, 71621
Sponsors and Collaborators
Assiut University
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Responsible Party: Abdelrahman Mohamed Abdelkader, chief resident of urology, Assiut University
ClinicalTrials.gov Identifier: NCT04725292    
Other Study ID Numbers: penis skin lesion
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Penile Diseases
Skin Diseases