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CompletedNCT04725292Updated Jan 26, 2021

Rare Benign Lesion of Peins

An observational study in Skin Diseases and Penile Diseases, sponsored by Assiut University. Completed at 1 site in Egypt. Open to male participants aged 35 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-26.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
1
Ages
35 Years to 50 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Skin Diseases
  • Penile Diseases

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03

In context

Skin Diseases

538 studies on the registry are indexed under Skin Diseases; 91 are open to participants now.

This study's enrollment of 1 is below the median of 168 across 147 observational studies indexed under Skin Diseases.

Browse Skin Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

male healthy married

Inclusion criteria

  • 40 years
  • failed medical treatment

Exclusion criteria

Exclusion Criteria:

  • psoriasis
  • allergy
  • trauma
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
1 participant (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. improvement of the skin lesion

    drugs will be given to patient then the effect ,either improvement or worsening will be noticied

    Time frame: 1 month after treatment

  2. improvement of associated lesion

    patient complained of difficulty and burning micturition which will be seen after treatment

    Time frame: 1 month after drug given

07

Study locations

1 site
  • Assuit Medical School
    Assiut, Assuit 71621, Egypt
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04725292
Lead sponsor
Assiut University
Responsible party
Abdelrahman Mohamed Abdelkader (chief resident of urology, Assiut University) — Principal investigator
First posted
Jan 26, 2021
Start date
Jan 12, 2021
Primary completion
Jan 12, 2021
Completion
Jan 12, 2021
Last update
Jan 26, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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