NCT01453179

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_4

Geographic Reach
2 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 17, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 7, 2022

Status Verified

April 1, 2015

Enrollment Period

3.4 years

First QC Date

September 30, 2011

Last Update Submit

February 4, 2022

Conditions

Actinic Keratosis

Keywords

actinic keratosisinvasive SCCin situ SCChistological classificationhistological progressionclinical clearancecryotherapy

Outcome Measures

Primary Outcomes (1)

  • Long-term outcome with respect to the risk of progression to SCC (in situ and/or invasive) of treatment with Aldara® 5% cream (IMIQ) and Solaraze® 3% gel (DIC) with increased precision (meta-analysis with study 3271).

    3 years

Secondary Outcomes (4)

  • Recurrence rate

    3 years

  • Time to recurrence

    3 years

  • Need of rescue treatment

    3 year

  • Cosmetic outcome

    3 years

Study Arms (2)

Aldara 5% Cream

EXPERIMENTAL
Drug: Imiquimod

Solaraze 3% Gel

ACTIVE COMPARATOR
Drug: Diclofenac

Interventions

ImiquimodDRUG

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.

Aldara 5% Cream
DiclofenacDRUG

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.

Solaraze 3% Gel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be eligible, a patient must comply with all of the following criteria:
  • Immunocompetent patient.
  • A study treatment area must be identifiable: Minimum of 5 and maximum of 10 typical visible AKs in one contiguous area of up to 50 cm2 on the face or scalp. The eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border must not be part of this area.
  • A positive histological finding for AK grade I or II. This will be determined from the most suspicious lesion in the STA and there from the most pathological area biopsied during screening visit. This analysis will be done by the central histopathological laboratory.
  • Willingness to comply with the obligations of the study.

You may not qualify if:

  • A patient is ineligible and must not enter the study if any of the following criteria is met:
  • Safety concerns:
  • History of hypersensitivity to imiquimod, diclofenac, acetyl salicylic acid, other non steroidal anti-inflammatory drugs (NSAID), hyaluronic acid, or relevant excipients.
  • Pregnancy, breast-feeding or planned pregnancy during the study. Women of child bearing potential not using a highly effective method of birth control defined as those which result in a low failure rate (i.e. \<1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner.
  • Lack of suitability for the study:
  • Presence of AK lesions in the STA with clinically excessive hyperkeratosis as seen in cutaneous horns.
  • Any topical AK treatment including imiquimod or diclofenac, or any systemic AK treatment such as systemic retinoids, or any surgical AK treatment at the STA within the last 2 months prior to randomisation.
  • Persisting AK lesion at screening visit following topical treatment with imiquimod or diclofenac in the STA.
  • Presence of any histologically confirmed skin tumour in the STA: in situ SCC including Bowen's disease, invasive SCC, basal cell carcinoma, or other malignant tumours.
  • Any dermatological disease or condition that may exacerbate by treatment with imiquimod or diclofenac (e.g. rosacea, psoriasis, atopic dermatitis).
  • Any dermatological disease or condition in the STA that causes difficulty with examination (e.g. eczema).
  • Systemic immunomodulatory treatment such as interferon, azathioprine, cyclosporine, retinoids, any oral or injectable corticosteroids, or inhaled or nasal corticosteroids with dosages of \>1200 µg/day beclomethasone or equivalent within 4 weeks before start of study treatment.
  • History of any malignant tumour with high tumour burden or any systemic antitumour treatment (incl. radiotherapy).
  • History of any malignant skin tumour having metastasised or in which metastasis within the study period is likely.
  • History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years which might hinder regular treatment and supervision and might lead to premature withdrawal from the study.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Medical University Graz, University Clinic for Dermatology and Venerology Graz

Graz, A-8036, Austria

Location

Medical Practice

Maria Enzersdorf, A-2344, Austria

Location

Medical University Vienna, Department for General Dermatology

Vienna, A-1090, Austria

Location

Medical Supply Center

Augsburg, D-86163, Germany

Location

Licca Clinical Research Institute, Clinic for Dermatolgy and Surgery

Augsburg, D-86179, Germany

Location

Medical Practice

Berlin, D-10437, Germany

Location

Medical Practice

Dülmen, D-48249, Germany

Location

Medical Practice

Germering, D-82110, Germany

Location

Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venerology

Magdeburg, D-39120, Germany

Location

Medical Practice

Mahlow, D-15831, Germany

Location

Department of Dermatology Johannes Gutenberg-University Mainz, Clinical Research Center

Mainz, D-55131, Germany

Location

Medical Practice

Markkleeberg, D-04416, Germany

Location

Medical Practice for Dermatology and Medical Cosmetics

Mönchengladbach, D-41061, Germany

Location

Medical Practice

Münster, D-48143, Germany

Location

Derma Center Vechta, Clinic for Dermatology

Vechta, D-49377, Germany

Location

Centrovital, Medical Practice for Dermatology

Witten, D-58453, Germany

Location

Medical Practice for Dermatology and Venerology

Wuppertal, D-42275, Germany

Location

Related Publications (1)

  • Gollnick H, Dirschka T, Ostendorf R, Kerl H, Kunstfeld R. Long-term clinical outcomes of imiquimod 5% cream vs. diclofenac 3% gel for actinic keratosis on the face or scalp: a pooled analysis of two randomized controlled trials. J Eur Acad Dermatol Venereol. 2020 Jan;34(1):82-89. doi: 10.1111/jdv.15868. Epub 2019 Sep 12.

    PMID: 31407414DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

ImiquimodDiclofenac

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Ursula Petzold, Dr.

    MEDA Pharma GmbH & Co. KG

    STUDY DIRECTOR

  • Harald Gollnick, Prof. Dr.

    Otto-von-Guericke-University of Magdeburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2011

First Posted

October 17, 2011

Study Start

October 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

February 7, 2022

Record last verified: 2015-04

Locations

AU(3)DE(14)