Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Facies

Keratosis, Actinic

Keratosis

Disease Progression

Skin Diseases

Precancerous Conditions

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Micronutrients

Anti-Infective Agents

Vitamins

Imiquimod

Diclofenac

Vitamin A

Retinol palmitate

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

Retinol

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.

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.

Harald Gollnick, MD, Prof.

Ursula Petzold, PhD

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 or Solaraze® 3% gel 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.

Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses

Long-term Effects of Aldara® 5% Cream and Solaraze® 3% Gel in the Treatment of Actinic Keratoses on the Face or Scalp (LEIDA)

A patient is classified as recurrent when cleared at Visit Week 20 and having later on at least one clinically diagnosed AK lesion in the study treatment area

MEDA Pharma GmbH & Co. KG

Carcinoma

Carcinoma, Squamous Cell

Ursula Petzold, Dr.

Harald Gollnick, Prof. Dr.

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.

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

Long-term Effects of Aldara® 5% Cream and Solaraze® 3% Gel in the Treatment of Actinic Keratoses on the Face or Scalp With Respect to the Risk of Progression to In-situ and Invasive Squamous Cell Carcinoma

Cosmetic outcome assessed by patient and investigator on a verbal rating scale.

Siro Clinpharm Germany GmbH (until June 2013)

Accovion GmbH

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses	NCT00777127	Actinic Keratos...	Imiquimod Diclofenac	18 Years -	Viatris Inc.
Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses (LEIDA 2)	NCT01453179	Actinic Keratos...	Imiquimod Diclofenac	18 Years -	Viatris Inc.

Spots Global Cancer Trial Database for histological progression