Cutaneous LeishmaniasisSCARNCT00490230
Cosmetic Outcome of Leishmaniasis Scar After WR279396 Application
A study testing WR 279396 in people with Cutaneous Leishmaniasis and Scar, run by U.S. Army Medical Research and Development Command at 1 site in Tunisia.
Trial summary
Primary Objectives: Assess whether CL (caused by Leishmaniasis major) lesions treated with WR279396 improved the cosmetic outcome compared with no treatment (natural healing) Read more about this study
- Who is it for?
- Ages 5 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Leishmaniasis, Scar
- What is being tested?
- WR 279396
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteTunisia
- Study dates
- Apr 2007to Jun 2007
- Phase
- Interventional
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Included are volunteers who participated in WRAIR 813 (HSRRB Log # 9768.1) and those who participated in another CL study in/around the WRAIR 813 study site who had been assigned to a "no-treatment" (natural healing) arm. All volunteers will have had documented CL in the past that were treated with WR279396, vehicle, or no treatment (natural history), have signed informed consent, and are willing to comply with study assessments; age range: 5 to 75 years old.
- For study subjects who were enrolled in WRAIR 813 in 2004 (WR279396 or vehicle treated):
- Written informed consent obtained from the subject or guardian
- Willing to meet the requirements of the single clinic visit
- Prior data in the clinical site data base documenting a diagnosis of CL
- Each lesion for inclusion in this study conforms to WRAIR 813: ³ 1 cm in diameter and was primarily ulcerative (i.e., not verrucous or nodular)
Show all 19Show fewer
- The index lesion and others to be scored were proven parasitologically by Giemsa slide smear
- CL scars documented to be > 360 days old (clock starts at time of diagnosis)
- No treatment of the lesions other than that received in the previous protocol
- Study subjects from the earlier studies to serve as "no treatment" controls:
- Written informed consent obtained from the subject or guardian
- Willing to meet the requirements of the single clinic visit
- Same age range as WRAIR 813: 5-75 years old at time of diagnosis
- Prior data in the clinical site data base documenting a diagnosis of CL, and that the volunteer was assigned to the "no treatment" group
- Each lesion for inclusion in this study will conform to WRAIR 813: at the time of diagnosis, ≥1 cm in diameter and described as primarily ulcerative (i.e., not verrucous or nodular)
- At least 1 lesion that was proven parasitologically by Giemsa slide smear for inclusion in the earlier study.
- CL scars documented to be > 360 days old (clock starts at time of diagnosis)
- Never received any treatment of the lesions (natural healing) or applied any medication, such as herbal medication
- Lesions present on the trunk or extremities, to match the WRAIR 813 study volunteers (no facial lesions were treated in the 2004 study)
Who cannot join
- Potential volunteers without a prior documented diagnosis of CL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Cutaneous Leishmaniasis Scar (Caused by Leishmania Major) for Cosmetic Outcome After Treatment With WR279396 (Paromomycin/Gentamicin Cream in Vehicle) Versus a No Treatment Control Group (Natural Healing)
Primary Objectives:
Assess whether CL (caused by Leishmaniasis major) lesions treated with WR279396 improved the cosmetic outcome compared with no treatment (natural healing)
Read the detailed description
Secondary Objectives
- Evaluate the cosmetic outcome of CL lesions treated with "vehicle" compared with no treatment (natural healing)
- Evaluate the cosmetic outcome of CL lesions treated with "vehicle" compared with WR279396
- To determine whether CL lesions treated with vehicle improves the cosmetic outcome (compared with natural healing)
- To determine whether CL lesions treated with vehicle alone provides a cosmetic outcome similar to WR279396
- Conditions
- Cutaneous Leishmaniasis, Scar
- Being tested
- WR 279396
- Keywords
- Paromomycin, Gentamicin
- Medical subject headings
- Leishmaniasis, Cutaneous, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WR 279396Drug
| Study group | Role | What they receive |
|---|---|---|
| WR 279,396 | Experimental | CL lesions treated with WR 279396 Receives: Drug: WR 279396 |
| Natural Healing | No intervention | CL lesions healed naturally |
| vehicle control | Placebo comparator | CL lesions were treated with the vehicle alone Receives: Drug: WR 279396 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic outcome based on modified Vancouver Scar Score (mVSS)
The primary cosmetic outcome measure is the Clinical Scar Rating, based on a modified Vancouver Scar Score (mVSS). The primary efficacy endpoint is the percent of persons judged to have either a "superior (no scar)" or "excellent" rating (see below).
Measured: Day 360 or greater
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2007 (estimated)
- Study startApr 2007
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Institut Pasteur
- Responsible party
- Sponsor
- Investigators
- COL Doug Walsh, MD, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490230
- Sponsor's protocol ID
- WRAIR 1303
- Acronym
- SCAR
- Status last verified
- Dec 2015
- First submitted
- 20 Jun 2007
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cutaneous Leishmaniasis Scar (Caused by Leishmania Major) for Cosmetic Outcome After Treatment With WR279396 (Paromomycin/Gentamicin Cream in Vehicle) Versus a No Treatment Control Group (Natural Healing)
- ClinicalTrials.gov ID
- NCT00490230
- Acronym / sponsor ID
- SCAR / WRAIR 1303
- Conditions
- Cutaneous Leishmaniasis, Scar
- Keywords
- Paromomycin, Gentamicin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Institut Pasteur
- Study start
- Apr 2007
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 22 Jun 2007 (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.
Primary Objectives:
Assess whether CL (caused by Leishmaniasis major) lesions treated with WR279396 improved the cosmetic outcome compared with no treatment (natural healing)
Detailed description
Secondary Objectives
- Evaluate the cosmetic outcome of CL lesions treated with "vehicle" compared with no treatment (natural healing)
- Evaluate the cosmetic outcome of CL lesions treated with "vehicle" compared with WR279396
- To determine whether CL lesions treated with vehicle improves the cosmetic outcome (compared with natural healing)
- To determine whether CL lesions treated with vehicle alone provides a cosmetic outcome similar to WR279396
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WR 279,396 | Experimental | Drug: WR 279396CL lesions treated with WR 279396 |
| Natural Healing | No intervention | –CL lesions healed naturally |
| vehicle control | Placebo comparator | Drug: WR 279396CL lesions were treated with the vehicle alone |
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Included are volunteers who participated in WRAIR 813 (HSRRB Log # 9768.1) and those who participated in another CL study in/around the WRAIR 813 study site who had been assigned to a "no-treatment" (natural healing) arm. All volunteers will have had documented CL in the past that were treated with WR279396, vehicle, or no treatment (natural history), have signed informed consent, and are willing to comply with study assessments; age range: 5 to 75 years old.
- For study subjects who were enrolled in WRAIR 813 in 2004 (WR279396 or vehicle treated):
- Study subjects from the earlier studies to serve as "no treatment" controls:
Key exclusion criteria (1 listed)
- Potential volunteers without a prior documented diagnosis of CL
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 |
|---|---|---|
| WR 279396 | Drug | WR 279,396, vehicle control |
Primary outcome
Cosmetic outcome based on modified Vancouver Scar Score (mVSS)
Time frame: Day 360 or greater
The primary cosmetic outcome measure is the Clinical Scar Rating, based on a modified Vancouver Scar Score (mVSS). The primary efficacy endpoint is the percent of persons judged to have either a "superior (no scar)" or "excellent" rating (see below).
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 1 Jan 2016.
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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.
COL Doug Walsh, MD principal investigator
Walter Reed Army Institute of Research (WRAIR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WR 279396 in people with Cutaneous Leishmaniasis and Scar, run by U.S. Army Medical Research and Development Command at 1 site in Tunisia.
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 19 inclusion and 1 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 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Cosmetic outcome based on modified Vancouver Scar Score (mVSS) (time frame: Day 360 or greater). 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 1 Jan 2016.