Cutaneous LeishmaniasisPhase 3NCT00257530
Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis
A Phase 3 study testing Imiquimod in people with Cutaneous Leishmaniasis, run by Drugs for Neglected Diseases at 2 sites in Peru.
Trial summary
This study will test whether addition of imiquimod to standard antimony therapy provides a significant benefit in subjects with newly diagnosed cutaneous leishmaniasis. Based on our previous results, we hypothesize that lesions in patients who receive the combined treatment of pentavalent antimony and imiquimod as a… Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- Imiquimod
- How many people
- 80 participants
- Where
- 2 sitesPeru
- Study dates
- Dec 2005to Jun 2006
- Phase
- Phase 3
- 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 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males/Females between 5 and 65 yrs
- CL diagnosis confirmed
- >4 weeks time disease
- no prior anti-leishmanial therapy for CL
- negative pregnancy test
- informed written consent or parent consent for <18yrs patients
Who cannot join
- >25cm2 lesion(s)
- >6 cutaneous lesions
- mucosal lesion
- previous exposure to Imiquimod or anti-leish treatment
- participation in another protocol within 30 days prior study
- other acute or chronic illness / medication that may interfere
Show all 11Show fewer
- significant psychiatric illness
- anaphylaxis or severe allergic reaction to proposed drugs
- patients unlikely to cooperate
- concomitant infection
- pregnancy or breast feeding
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Randomized Double Blind Clinical Trial of Imiquimod (Aldara) Versus Placebo Used in Combination With Pentavalent Antimony (Glucantime) in Peruvian Cutaneous Leishmaniasis Patients
This study will test whether addition of imiquimod to standard antimony therapy provides a significant benefit in subjects with newly diagnosed cutaneous leishmaniasis. Based on our previous results, we hypothesize that lesions in patients who receive the combined treatment of pentavalent antimony and imiquimod as a first line therapy will resolve more rapidly and produce less scarring than treatment with pentavalent antimony alone.
- Conditions
- Cutaneous Leishmaniasis
- Being tested
- Imiquimod
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImiquimodDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to healing
Reduction of scaring
Secondary outcomes (1)
Safety (measured by AE reporting) during treatment and follow up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2005 (estimated)
- Study startDec 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous LeishmaniasisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Investigators
- Catherine Royce, Dr, Study chair, Drugs for Neglected Diseases initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257530
- Sponsor's protocol ID
- DNDi-IMQ-05
- Status last verified
- Jun 2008
- First submitted
- 22 Nov 2005
- Last updated
- 12 Jun 2008
- Results posted
- No
Publications
Miranda-Verastegui C, Tulliano G, Gyorkos TW, Calderon W, Rahme E, Ward B, Cruz M, Llanos-Cuentas A, Matlashewski G. First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony. PLoS Negl Trop Dis. 2009 Jul 28;3(7):e491. doi: 10.1371/journal.pntd.0000491.
PubMed 19636365
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Clinical Trial of Imiquimod (Aldara) Versus Placebo Used in Combination With Pentavalent Antimony (Glucantime) in Peruvian Cutaneous Leishmaniasis Patients
- ClinicalTrials.gov ID
- NCT00257530
- Acronym / sponsor ID
- DNDi-IMQ-05
- Conditions
- Cutaneous Leishmaniasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 23 Nov 2005 (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 study will test whether addition of imiquimod to standard antimony therapy provides a significant benefit in subjects with newly diagnosed cutaneous leishmaniasis. Based on our previous results, we hypothesize that lesions in patients who receive the combined treatment of pentavalent antimony and imiquimod as a first line therapy will resolve more rapidly and produce less scarring than treatment with pentavalent antimony alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Males/Females between 5 and 65 yrs
- CL diagnosis confirmed
- >4 weeks time disease
- no prior anti-leishmanial therapy for CL
- negative pregnancy test
Key exclusion criteria (11 listed)
- >25cm2 lesion(s)
- >6 cutaneous lesions
- mucosal lesion
- previous exposure to Imiquimod or anti-leish treatment
- participation in another protocol within 30 days prior study
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 |
|---|---|---|
| Imiquimod | Drug | – |
Primary outcome
Time to healing
Reduction of scaring
1 secondary outcome
Safety (measured by AE reporting) during treatment and follow up to 12 months
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 12 Jun 2008.
- Derived from this study: PubMed 19636365Miranda-Verastegui C, Tulliano G, Gyorkos TW, Calderon W, Rahme E, Ward B, Cruz M, Llanos-Cuentas A, Matlashewski G. First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony. PLoS Negl Trop Dis. 2009 Jul 28;3(7):e491. doi: 10.1371/journal.pntd.0000491.
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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.
Catherine Royce, Dr study chair
Drugs for Neglected Diseases initiative
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imiquimod in people with Cutaneous Leishmaniasis, run by Drugs for Neglected Diseases at 2 sites in Peru.
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 6 inclusion and 11 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 12 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Peru. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time to healing. The study lists 2 primary outcomes in all. 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 NCT00257530, 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 12 Jun 2008.