Clinical Trial: Topical 5% Imiquimod Cream for Vulvar Paget's Disease

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Topical 5% Imiquimod Cream for Vulvar Paget's Disease: Clinical Efficacy, Safety and Immunological Response

Brief Summary: The purpose of this study is to evaluate the efficacy, safety and immunological response of topical 5% imiquimod cream for non-invasive vulvar Paget's disease.

Detailed Summary:

Vulvar Paget's disease is a rare skin tumour and generally seen in postmenopausal, Caucasian women as an erythematous, eczematous, scaling or ulcerating plaque. Initial symptoms are irritation, burning, pain and a skin lesion. The origin of vulvar Paget's disease is not yet entirely understood. The treatment of choice is surgical excision, despite high recurrence rates. The mutilating consequences of surgery can lead to impressive morbidity to address this, several series report the use of topical 5% imiquimod cream for vulvar Paget's disease.

The objective of this study is to assess the efficacy, evaluate the safety, immunological effect of topical 5% imiquimod cream for vulvar Paget's disease and the quality of life during treatment.


Sponsor: University Medical Center Nijmegen

Current Primary Outcome: Clinical response [ Time Frame: 12 weeks after the end of treatment ]

Clinical response will be assessed by vulvar examination and measurement and is defined as complete remission, partial remission (decrease by ≥50% of total lesion size) or no remission.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tolerability questionnaire [ Time Frame: 4, 10 and 16 weeks after the start of treatment ]

    Tolerability will be assessed in a descriptive manner with a tolerability questionnaire with the following questions:

    1. Have you used paracetamol during treatment?

      1. How many days?
      2. What dosage?
      3. Was the use sufficient?

    2. Have you used lidocaine in Vaseline ointment during treatment?

      1. How many days?
      2. What dosage?
      3. Was the use sufficient?
    3. Have you stopped the treatment with imiquimod because of side effects/pain?
  • Adverse events [ Time Frame: 4, 10 and 16 weeks after the start of treatment ]

    Most common adverse events will be evaluated with the following questions:

    1. Have you been nauseous? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.
    2. Have you had a head ache? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.
    3. Have you felt more tired than you normally are? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.
  • Immunological response [ Time Frame: Baseline, 4 and 28 weeks after start of treatment ]
    Vulvar skin biopsies will be taken at baseline, 4 and 28 weeks after the start of
  • Quality of life: general. [ Time Frame: Baseline, 4 and 28 weeks after start of treatment. ]
    The questionnaire EQ5D (EuroQOL 5 Dimensions questionnaire) will be used.
  • Quality of life: dermatology specific. [ Time Frame: Baseline, 4 and 28 weeks after start of treatment. ]
    The questionnaire DLQI (Dermatology Life Quality Index) will be used.
  • Quality of life: sexuality. [ Time Frame: Baseline, 4 and 28 weeks after start of treatment. ]
    The questionnaire FSDS (Female Sexual Distress Scale) will be used.


Original Secondary Outcome: Same as current

Information By: University Medical Center Nijmegen

Dates:
Date Received: February 5, 2015
Date Started: May 2015
Date Completion: September 2018
Last Updated: March 27, 2017
Last Verified: March 2017