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The purpose of the study is to obtain recurrence rates and long-term safety data for patients who had been treating actinic keratoses on the face and scalp with 5 % Imiquimod Cream in a previous study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imiquimod 5% cream | No investigational treatments were given during this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imiquimod | Drug | No defined treatments were given during this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Efficacy was evaluated by counting AK lesions in the previous treatment area. Subjects at the 1-year follow-up visit with recurrence of lesion(s). | one year after completion of study 1487-Imiq |
| Safety | Safety was evaluated by assessing the area of previous treatment for LSRs and skin quality | one year after completion of study 1487-Imiq |
| Adverse Events | AEs considered by investigator to be possibly or probably related to the 1487-Imiq study medication were documented and recorded. | one year after completion of study 1487-Imiq |
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Inclusion Criteria:
Exclusion Criteria:
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At least 18 years old. Females of childbearing potential, with a negative urine pregnancy test, must have been willing to use a medically acceptable method of contraception during the treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Study Coordinator | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Study Chair |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D006571 | Heterocyclic Compounds |