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Actinic KeratosisPhase 4LEIDA 2NCT01453179

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

A Phase 4 study testing Imiquimod and Diclofenac in people with Actinic Keratosis, run by MEDA Pharma GmbH & Co. KG at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Actinic Keratosis
What is being tested?
Imiquimod and Diclofenac
Could I receive a placebo?
No, everyone receives an active treatment
How many people
221 participants
Where
17 sitesin 2 countries
Study dates
Oct 2011to Mar 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Mentally incapacitated patient.
  • Present or history of drug or alcohol abuse within the last 3 years.
  • Administrative reasons:
  • Exposure to an investigational product within the last 3 months.
  • Lack of ability or willingness to give informed consent.
  • Age below 18 years.
  • Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.
  • Anticipated non-availability for study visits/procedures.
  • Vulnerable subjects (such as persons kept in detention).

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

Germany14 sites

  • Medical Supply Center

    Augsburg, D-86163

  • Licca Clinical Research Institute, Clinic for Dermatolgy and Surgery

    Augsburg, D-86179

  • Medical Practice

    Berlin, D-10437

  • Medical Practice

    Dülmen, D-48249

  • Medical Practice

    Germering, D-82110

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

    Magdeburg, D-39120

  • Medical Practice

    Mahlow, D-15831

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

    Mainz, D-55131

  • Medical Practice

    Markkleeberg, D-04416

  • Medical Practice for Dermatology and Medical Cosmetics

    Mönchengladbach, D-41061

  • Medical Practice

    Münster, D-48143

  • Derma Center Vechta, Clinic for Dermatology

    Vechta, D-49377

  • Centrovital, Medical Practice for Dermatology

    Witten, D-58453

  • Medical Practice for Dermatology and Venerology

    Wuppertal, D-42275

Other trials in Germany

Austria3 sites

  • Medical University Graz, University Clinic for Dermatology and Venerology Graz

    Graz, A-8036

  • Medical Practice

    Maria Enzersdorf, A-2344

  • Medical University Vienna, Department for General Dermatology

    Vienna, A-1090

Other trials in Austria

About this study

Official title: 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

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.

Being tested
Imiquimod, Diclofenac
Keywords
actinic keratosis, invasive SCC, in situ SCC, histological classification, histological progression, clinical clearance, cryotherapy
Medical subject headings
Keratosis, Actinic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT01453179
Study groupRoleWhat they receive
Aldara 5% CreamExperimentalNot described
Receives: Drug: Imiquimod
Solaraze 3% GelActive comparatorNot described
Receives: Drug: Diclofenac

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 3 years

Secondary outcomes (4)

  1. Recurrence rate

    Measured: 3 years

  2. Time to recurrence

    Measured: 3 years

  3. Need of rescue treatment

    Measured: 3 year

  4. Cosmetic outcome

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01453179
Sponsor's protocol ID
X-03016-3284
Other IDs
2010-022054-16
Acronym
LEIDA 2
Status last verified
Apr 2015
First submitted
30 Sep 2011
Last updated
7 Feb 2022
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31407414

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Imiquimod and Diclofenac in people with Actinic Keratosis, run by MEDA Pharma GmbH & Co. KG at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01453179, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.

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