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Completed

NCT Number: NCT04725292

Rare Benign Lesion of Peins

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.

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Key information

Age range

35 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

Assuit Medical School

Asyut, Assuit, 71621, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 40 years
  • failed medical treatment

Exclusion criteria

  • psoriasis
  • allergy
  • trauma

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Pseudoepitheliomatous Hyperplasia of the Penis a Very Rare Disease in Egypt

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 26, 2021
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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