NCT04725292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

Same day

First QC Date

January 16, 2021

Last Update Submit

January 25, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • improvement of the skin lesion

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

    1 month after treatment

  • improvement of associated lesion

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

    1 month after drug given

Eligibility Criteria

Age35 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailscase report
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

male healthy married

You may qualify if:

  • years
  • failed medical treatment

You may not qualify if:

  • psoriasis
  • allergy
  • trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit Medical School

Asyut, Assuit, 71621, Egypt

Location

MeSH Terms

Conditions

Skin DiseasesPenile Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief resident of urology

Study Record Dates

First Submitted

January 16, 2021

First Posted

January 26, 2021

Study Start

January 12, 2021

Primary Completion

January 12, 2021

Study Completion

January 12, 2021

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations