Actinic KeratosisPhase 4LEIDANCT00777127
Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses
A Phase 4 study testing Imiquimod and Diclofenac in people with Actinic Keratosis, run by MEDA Pharma GmbH & Co. KG at 26 sites in 3 countries.
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 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. 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
- 258 participants
- Where
- 26 sitesin 3 countries
- Study dates
- Dec 2008to Nov 2012
- 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
- 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 (see Section 7.1.1.2). 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
- Safety concerns:
- History of allergic reaction 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 marked hyperkeratosis or hypertrophy 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.
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- Persisting AK lesion at screening visit following topical treatment with imiquimod or diclofenac in the STA.
- Topical treatment with imiquimod or diclofenac anywhere else on the body within the last 2 months prior to randomisation.
- 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 where metastasis could be expected.
- History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years.
- 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
26 sites in 3 countries.
26 sites in 3 countries
Germany17 sites
Licca Clinical Research Institute
Augsburg, D-86179
Charite - Medicine University Berlin, Dermatoma Center, Clinic for Dermatology, Allergology and Venereology
Berlin, D-10117
Medical Practice Dominicus / Bockhorst
Dülmen, D-48249
Medical practice
Düsseldorf, D-40210
University Clinic Düsseldorf, Clinic for Dermatology
Düsseldorf, D-40255
Clinic and Medical Faculty of Johann Wolfgang Goethe-University, Center for Dermatology and Venereology
Frankfurt am Main, D-60590
SCiderm GmbH
Hamburg, D-20354
Medical Practice
Hanover, D-30159
University Clinic Schleswig-Holstein, Campus Kiel, Clinic for Dermatology, Venereology and Allergology
Kiel, D-24105
Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venereology
Magdeburg, D-39120
Department of Dermatology J. Gutenberg-University Mainz, Clinical Research Center
Mainz, D-55131
Science, Onco & Beauty GbR, Practice for Dermatology and Medical Cosmetics
Mönchengladbach, D-41061
University Clinic Münster, Clinic and Polyclinic for Skin Diseases
Münster, D-48149
Clinic University Regensburg, Clinic and Polyclinic for Dermatology
Regensburg, D-93053
Derma Center Vechta
Vechta, D-49377
Centrovital
Witten, D-58453
Medical practice for Dermatology and Venerology
Wuppertal, D-42275
France5 sites
CHU St Jacques, Department for Dermatology
Besançon, F-25030
Hospital Sainte Marguerite, Department for Dermatology and Venereology, Pavilion 3, First Floor
Marseille, F-13009
CHU Nice - Hospital Archet 2, Department for Dermatology
Nice, F-06202
Hospital Saint-Louis, Derpartment for Dermatology
Paris, F-75010
Hospital Center Lyon South, Department for Dermatology and Immuno-Allergology
Pierre-Bénite, F-69495
Austria4 sites
Hospital Feldkirch, Department for Dermatology and Venereology
Feldkirch, A-6807
Medical University Graz, University Clinic for Dermatology and Venereology
Graz, A-8036
Medical University Innsbruck, University Clinic for Dermatology and Venereology
Innsbruck, A-6020
Medical University Vienna, Department for General Dermatology
Vienna, A-1090
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 (LEIDA)
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.
- Conditions
- Actinic Keratosis
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Aldara 5% Cream Receives: Drug: Imiquimod |
| 2 | Active comparator | Solaraze 3% Gel Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence with respect to the study treatment area until month 12
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
Measured: week 20 until month 12
Secondary outcomes (5)
Time to recurrence
Measured: 3 years
Long-term outcome with respect to development of SCC (in situ and/or invasive)
Measured: 3 years
Need of rescue treatment
Measured: 3 years
Haematological changes
Measured: 20 weeks
Cosmetic outcome.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEDA Pharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harald Gollnick, MD, Prof., Principal investigator, Otto-von-Guericke-University of Magdeburg/Germany, Clinic for Dermatology and VenereologyUrsula Petzold, PhD, Study director, MEDA Pharma GmbH & Co. KG, Bad Homburg/Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777127
- Sponsor's protocol ID
- X-03016-3271
- Other IDs
- 2007-004884-24
- Acronym
- LEIDA
- Status last verified
- Jan 2013
- First submitted
- 21 Oct 2008
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Aldara® 5% Cream and Solaraze® 3% Gel in the Treatment of Actinic Keratoses on the Face or Scalp (LEIDA)
- ClinicalTrials.gov ID
- NCT00777127
- Acronym / sponsor ID
- LEIDA / X-03016-3271
- Conditions
- Actinic Keratosis
- Keywords
- actinic keratosis, invasive SCC, in situ SCC, histological classification, histological progression, clinical clearance, cryotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- MEDA Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ImiquimodAldara 5% Cream |
| 2 | Active comparator | Drug: DiclofenacSolaraze 3% Gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (see Section 7.1.1.2). 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.
Key exclusion criteria (24 listed)
- History of allergic reaction 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.
- Presence of AK lesions in the STA with clinically marked hyperkeratosis or hypertrophy 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImiquimodOne 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 | 1 |
| DiclofenacSolaraze® 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. | Drug | 2 |
Primary outcome
Recurrence with respect to the study treatment area until month 12
Time frame: week 20 until month 12
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
5 secondary outcomes
Time to recurrence
Time frame: 3 years
Long-term outcome with respect to development of SCC (in situ and/or invasive)
Time frame: 3 years
Need of rescue treatment
Time frame: 3 years
Haematological changes
Time frame: 20 weeks
Cosmetic outcome.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- European Dermatology Forum, Guidelines for the management of actinic keratoses. Last modified 26 Ocotober 2006.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald Gollnick, MD, Prof. principal investigator
Otto-von-Guericke-University of Magdeburg/Germany, Clinic for Dermatology and Venereology
Ursula Petzold, PhD study director
MEDA Pharma GmbH & Co. KG, Bad Homburg/Germany
26 sites in 3 countries: see every site and its status.
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 26 sites in 3 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 4 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 26 sites in Germany, France, 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?
Recurrence with respect to the study treatment area until month 12 (time frame: week 20 until month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.