Trial on Preventing Basal Cell Skin Cancer with Cream Treatment

Sponsor: VA Office of Research and Development

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05212246

Provider View

This study is testing whether a cream called Imiquimod (IMQ) can help prevent basal cell carcinoma (BCC), a common skin cancer, on the face. Participants will apply either the IMQ cream or a placebo cream to their face every night for 12 weeks. The trial involves 1630 Veterans at high risk for BCC from 17 VA medical centers.

Patient Parameters

Program Overview

The study aims to find out if using a cream called Imiquimod (IMQ) can prevent basal cell carcinoma (BCC), a common type of skin cancer, from developing on the face. Participants will apply either the IMQ cream or a placebo cream to their face every night for 12 weeks. The study will take place at 17 VA medical centers and will involve 1630 Veterans who are at high risk for BCC. The study will last for three years, with regular check-ups to monitor the skin and gather information about the cream's effectiveness.

Description

Basal Cell Carcinoma (BCC) is the most common type of cancer in the United States, affecting millions of people each year. Veterans and active duty military personnel are at a higher risk of developing BCC, especially on the face, which can lead to significant health issues and costs. This study is exploring whether a cream called Imiquimod (IMQ), which is already approved for treating certain skin conditions, can also prevent BCC from developing.

The trial will involve 1630 Veterans from 17 VA medical centers. Participants will be randomly assigned to apply either the IMQ cream or a placebo cream to their face every night for 12 weeks. Neither the participants nor the study staff will know which cream is being used. Participants will have regular in-person visits and phone interviews to monitor their skin and gather data on the cream's effectiveness. The study will last for three years, with an additional year of follow-up using medical records.

The study will also test whether sending daily reminders through an app can help participants remember to apply the cream. The goal is to see if IMQ can prevent BCC or reduce the risk of developing it, potentially offering a new way to protect against this common skin cancer.

Eligibility Criteria

Inclusion Criteria

  • Veteran aged 18 years or older.
  • Have had at least two basal cell carcinoma (BCC) lesions in the past five years, with at least one on the face, neck, ears, or scalp.
  • Lesions must not be in an area that has received radiation therapy.
  • Lesions must not be a recurrence after treatment, but the original lesion can qualify whether it recurred or not.

Exclusion Criteria

  • Recent treatment on the face with certain creams or therapies for BCC in the last two months.
  • Use of Imiquimod (IMQ) on the face in the past year.
  • Suspicious skin lesions on the face that suggest skin cancer must be removed and cleared before joining the study.
  • Recent or current use of certain cancer treatments or medications.
  • History of specific types of cancer or genetic disorders that increase skin cancer risk.
  • Organ or bone marrow transplant recipients.
  • Previous radiation therapy to the face.
  • Known allergy to Imiquimod or the cream base.
  • Women who are pregnant, breastfeeding, or not using birth control.
  • High risk of mortality within a year due to other illnesses.
  • Unlikely to follow study requirements or unable to provide informed consent.
  • Unable to communicate in English.
  • Participation in another treatment trial.

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