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Completed

NCT Number: NCT00129519

A Study to Evaluate the Effectiveness of Imiquimod 5% Cream for Basal Cell Carcinoma Recurrence

The primary objective of this study is to assess whether basal cell carcinoma (BCC) lesions surgically treated with curettage, followed by imiquimod 5% cream as postsurgical adjuvant therapy, will have an improved cure rate over the ED/C historical norm of approximately 70% at 1-year posttreatment follow-up. A secondary objective is to assess cosmetic outcome.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Grass Valley, California, United States

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About this study

This was an open-label, phase IIIb, multicenter, single arm, historical-controlled study. Biopsy-confirmed BCC lesions (1 per subject) were excised by curettage, with no electrodessication. Approximately 1 week later, treatment with imiquimod 5% cream was initiated. Imiquimod was applied to the target BCC once daily, 5 times per week (5x/week) for up to 6 weeks. Rest periods were allowed as needed. Subjects reported to the study center at treatment weeks 1, 2, and 6, and posttreatment at weeks 12, 26, and 52. At treatment week 6 and all posttreatment visits, the investigator clinically assessed the target site for tumor clearance and cosmetic outcome. A template made at initiation and created from clear plastic overlay aided in locating the target tumor site. If the investigator identified a lesion that had occurred or recurred at the target site, the subject was discontinued from the study and counted as a recurrence/persistence (R/P).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Basal cell carcinoma

Exclusion criteria

  • Psoriasis

Treatment and study plan

Imiquimod 5% Cream

Drug

Imiquimod 5% cream applied once daily 5x/week for up to 6 weeks

Primary outcomes

  1. Number of subjects with recurrence

    Time frame: 1 year posttreatment

    Primary variable was the proportion of subjects with recurrence/persistence (R/P)of BCC at 1 year posttreatment

Secondary outcomes

  1. Cosmetic outcome of the target lesion

    Time frame: 1 year posttreatment

    The cosmetic outcome of the target lesion at 1 year posttreatment was the secondary efficacy measurement. The investigator judged cosmetic outcome by using a visual analog scale (VAS) to assess the parameters of hypo- and hyperpigmentation,roughness, scarring, and overall skin health and appearance.

Sponsors and collaborators

Lead sponsor

Graceway Pharmaceuticals, LLC

Industry

Registry information

Official study title

Open-label Study to Evaluate the Use of Imiquimod 5% Cream for Reducing Postsurgical Recurrence or Persistence of Basal Cell Carcinoma Following Excision by Curettage

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Aug 12, 2005
Registry last updated
Jul 16, 2010

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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