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NCT00189254 Clinical Trial

A Study to Follow up Recurrence Rates of Actinic Keratoses One Year After Completion of Study 1487-IMIQ

Actinic Keratoses Clinical Trial

Official title:
A Follow-up Study to Evaluate Actinic Keratosis Recurrence Rates One Year After Completion of the 1487-IMIQ Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00189254
Other study ID # 1524-IMIQ
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2005
Est. completion date November 2005

Study information
Verified date April 2015
Source Viatris Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date November 2005
Est. primary completion date November 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 100% clearance of Actinic Keratosis (AK) lesions in the 1487 IMIQ study Exclusion Criteria: - used any treatments in the previous treatment area within 24 hours prior to the follow-up visit

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Imiquimod
No defined treatments were given during this study.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
MEDA Pharma GmbH & Co. KG

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Safety Safety was evaluated by assessing the area of previous treatment for LSRs and skin quality one year after completion of study 1487-Imiq
Primary 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
See also
  Status Clinical Trial Phase
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Completed NCT04085367 - Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face Phase 3
Completed NCT05937529 - Impact of Madecassoside and 5 % Panthenol Cream in Post Photodynamic Therapy for Actinic Keratosis N/A
Completed NCT02520700 - A Comparison of White-light and Daylight Topical Methyl 5-aminolaevulinic Acid Photodynamic Therapy for Actinic Keratoses N/A
Terminated NCT01538901 - Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients Phase 4
Completed NCT01354717 - Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo Phase 3
Completed NCT00742391 - A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations Phase 3
Completed NCT03285477 - A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp Phase 3
Suspended NCT03963102 - Duration of Ameluz Application in Acral Actinic Keratoses Response Phase 4
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Withdrawn NCT06026358 - Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands Phase 4
Completed NCT02622594 - Bilateral Comparison of Treatment of Facial Actinic Keratoses Using Microneedling and Photodynamic Therapy With Aminolevulinic Acid and Blue Light Versus Photodynamic Therapy With Aminolevulinic Acid and Blue Light Using Two Incubation Times Phase 4
Completed NCT00774787 - Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses Phase 4
Completed NCT00786994 - The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses Phase 2
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Completed NCT04024579 - Treatment of Actinic Keratosis With 5% KOH Solution
Completed NCT04843553 - Nicotinamide for Prevention of Pre-malignant Actinic Keratosis in Kidney Transplant Recipients Early Phase 1
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Completed NCT03279328 - Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents Phase 4
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