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Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses (LEIDA 2)

NCT01453179 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2022-02-07

No results posted yet for this study

Summary

This clinical trial serves the purpose to compare the long-term effects of a treatment of actinic keratosis - your skin disorder - using Aldara® 5% cream (Imiquimod) or Solaraze® 3% gel (Diclofenac) on the face or the scalp. In particular, it should be found out whether the healing effect of these two medications on the skin lesions (i.e. the damaged skin parts) can be maintained for a prolonged period.

Conditions

  • Actinic Keratosis

Interventions

DRUG

Imiquimod

One course of treatment (COT) consisting of an overnight application of IMIQ (1 sachet for up to 50 cm2), applied 3 nights per week (e.g. Monday, Wednesday, Friday) for 4 weeks followed by a 4 weeks treatment pause. If necessary, this may be followed by a second COT.

DRUG

Diclofenac

Solaraze® is applied locally to the skin 2 times daily and smoothed into the skin gently. The amount needed depends on the size of the lesion. Normally 0.5 grams (the size of a pea) of the gel is used on a 25 cm2 lesion site. The duration of therapy is 12 weeks.

Sponsors & Collaborators

  • Siro Clinpharm Germany GmbH (until June 2013)

    collaborator UNKNOWN

  • Accovion GmbH

    collaborator INDUSTRY

  • MEDA Pharma GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Ursula Petzold, Dr. · MEDA Pharma GmbH & Co. KG

  • Harald Gollnick, Prof. Dr. · Otto-von-Guericke-University of Magdeburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01453179 on ClinicalTrials.gov