LeishmaniasisNCT03009422
Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis.
A study testing Local application pentostam, intra-lisional pentostam and fractional CO2 laser in people with Leishmaniasis, run by Tel-Aviv Sourasky Medical Center.
Trial summary
The investigators will compare the common treatment for cutaneous leishmaniasis with intra-lesional Pentostam to fractional CO2 laser with topical application of Pentostam. Outcome will be final scar appearance assesd by two dermatologist and pain measurement by VAS. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Leishmaniasis
- What is being tested?
- Local application pentostam, intra-lisional pentostam and fractional CO2 laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jun 2017
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Objective cutaneous leishmaniasis diagnosis.
- More than one Lesion
Who cannot join
- Previous treatment
- Abnormal scarring
About this study
The investigators will compare the common treatment for cutaneous leishmaniasis with intra-lesional Pentostam to fractional CO2 laser with topical application of Pentostam.
Outcome will be final scar appearance assesd by two dermatologist and pain measurement by VAS.
Read the detailed description
20 healthy patients diagnosed will cutaneous leishmaniasis with more than one lesion will be recruited.
Half of the lesions will be treated with intra-lesional injections of Pentostam, and the other half by CO2 laser with topical application of Pentostam.
Each lesion will recieve 3 treatments, one month apart between treatments. The patients will scale pain level of each treatment. Final scar appearance will be assessed by two dermatologists, without knowing what treatment was applied to each lesion.
- Conditions
- Leishmaniasis
- Being tested
- Local application pentostam, intra-lisional pentostam, fractional CO2 laser
- Medical subject headings
- Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local application pentostamDrug
intra-lisional pentostamDrug
fractional CO2 laserDevice
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | CO2 fractional laser with local application of Pentostam Receives: Drug: Local application pentostam; Device: fractional CO2 laser |
| control | Active comparator | Intra-lesinal Pentostam injedction Receives: Drug: intra-lisional pentostam |
What is being measured
The primary outcome is the main question the study is designed to answer.
scar appearance
Each lesion will be photographed prior to treatment and at 6th month (Three months after last (3rd) treatment).Two dermatologist will asses each lesion outcome
Measured: At sixth month
Secondary outcomes (1)
Pain assessed by VAS
Measured: at one month, two months, and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startNov 2014
- Primary completionFeb 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for LeishmaniasisStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009422
- Sponsor's protocol ID
- TASMC-14-OA-371-CTIL
- Status last verified
- Dec 2016
- First submitted
- 14 Dec 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Monge-Maillo B, Lopez-Velez R. Therapeutic options for old world cutaneous leishmaniasis and new world cutaneous and mucocutaneous leishmaniasis. Drugs. 2013 Nov;73(17):1889-920. doi: 10.1007/s40265-013-0132-1.
PubMed 24170665Al-Natour SH. Update in the treatment of cutaneous leishmaniasis. J Family Community Med. 2009 May;16(2):41-7.
PubMed 23012189Arfan-ul-Bari, Simeen-ber-Rahman. Scar leishmaniasis. J Coll Physicians Surg Pak. 2006 Apr;16(4):294-5.
PubMed 16624197Kim DW, Hwang NH, Yoon ES, Dhong ES, Park SH. Outcomes of ablative fractional laser scar treatment. J Plast Surg Hand Surg. 2015 Apr;49(2):88-94. doi: 10.3109/2000656X.2014.919927. Epub 2014 May 21.
PubMed 24845386AlGhamdi K, Khurrum H. Successful treatment of atrophic facial leishmaniasis scars by co2 fractional laser. J Cutan Med Surg. 2014 Nov;18(6):379-84. doi: 10.2310/7750.2014.13175.
PubMed 25348758Sklar LR, Burnett CT, Waibel JS, Moy RL, Ozog DM. Laser assisted drug delivery: a review of an evolving technology. Lasers Surg Med. 2014 Apr;46(4):249-62. doi: 10.1002/lsm.22227. Epub 2014 Mar 24.
PubMed 24664987Bloom BS, Brauer JA, Geronemus RG. Ablative fractional resurfacing in topical drug delivery: an update and outlook. Dermatol Surg. 2013 Jun;39(6):839-48. doi: 10.1111/dsu.12111. Epub 2013 Jan 7.
PubMed 23294061
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis.
- ClinicalTrials.gov ID
- NCT03009422
- Acronym / sponsor ID
- TASMC-14-OA-371-CTIL
- Conditions
- Leishmaniasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2014
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 4 Jan 2017 (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.
The investigators will compare the common treatment for cutaneous leishmaniasis with intra-lesional Pentostam to fractional CO2 laser with topical application of Pentostam.
Outcome will be final scar appearance assesd by two dermatologist and pain measurement by VAS.
Detailed description
20 healthy patients diagnosed will cutaneous leishmaniasis with more than one lesion will be recruited.
Half of the lesions will be treated with intra-lesional injections of Pentostam, and the other half by CO2 laser with topical application of Pentostam.
Each lesion will recieve 3 treatments, one month apart between treatments. The patients will scale pain level of each treatment. Final scar appearance will be assessed by two dermatologists, without knowing what treatment was applied to each lesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Local application pentostam, Device: fractional CO2 laserCO2 fractional laser with local application of Pentostam |
| control | Active comparator | Drug: intra-lisional pentostamIntra-lesinal Pentostam injedction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Objective cutaneous leishmaniasis diagnosis.
- More than one Lesion
Key exclusion criteria (2 listed)
- Previous treatment
- Abnormal scarring
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 |
|---|---|---|
| Local application pentostam | Drug | Treatment |
| intra-lisional pentostam | Drug | control |
| fractional CO2 laser | Device | Treatment |
Primary outcome
scar appearance
Time frame: At sixth month
Each lesion will be photographed prior to treatment and at 6th month (Three months after last (3rd) treatment).Two dermatologist will asses each lesion outcome
1 secondary outcome
Pain assessed by VAS
Time frame: at one month, two months, and three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Background: PubMed 24170665Monge-Maillo B, Lopez-Velez R. Therapeutic options for old world cutaneous leishmaniasis and new world cutaneous and mucocutaneous leishmaniasis. Drugs. 2013 Nov;73(17):1889-920. doi: 10.1007/s40265-013-0132-1.
- Background: PubMed 23012189Al-Natour SH. Update in the treatment of cutaneous leishmaniasis. J Family Community Med. 2009 May;16(2):41-7.
- Background: PubMed 16624197Arfan-ul-Bari, Simeen-ber-Rahman. Scar leishmaniasis. J Coll Physicians Surg Pak. 2006 Apr;16(4):294-5.
- Background: PubMed 24845386Kim DW, Hwang NH, Yoon ES, Dhong ES, Park SH. Outcomes of ablative fractional laser scar treatment. J Plast Surg Hand Surg. 2015 Apr;49(2):88-94. doi: 10.3109/2000656X.2014.919927. Epub 2014 May 21.
- Background: PubMed 25348758AlGhamdi K, Khurrum H. Successful treatment of atrophic facial leishmaniasis scars by co2 fractional laser. J Cutan Med Surg. 2014 Nov;18(6):379-84. doi: 10.2310/7750.2014.13175.
- Background: PubMed 24664987Sklar LR, Burnett CT, Waibel JS, Moy RL, Ozog DM. Laser assisted drug delivery: a review of an evolving technology. Lasers Surg Med. 2014 Apr;46(4):249-62. doi: 10.1002/lsm.22227. Epub 2014 Mar 24.
- Background: PubMed 23294061Bloom BS, Brauer JA, Geronemus RG. Ablative fractional resurfacing in topical drug delivery: an update and outlook. Dermatol Surg. 2013 Jun;39(6):839-48. doi: 10.1111/dsu.12111. Epub 2013 Jan 7.
Related trials for Leishmaniasis
RecruitingObservational study
Diagnosis and Treatment of Leishmania Infections
Kinetoplastid, Skin Diseases, Parasitic
Recruiting
Feasibility of Integrating Thermotherapy for Treatment of Cutaneous Leishmaniasis in Primary Health Care Setup
Cutaneous Leishmaniasis
Not yet recruiting
Immersive Technology Headsets to Reduce Procedural Pain and Anxiety: Feasibility and Effects in Cutaneous Leishmaniasis Patients in Pakistan
Cutaneous Leishmaniasis, Pain
RecruitingObservational study
Ex Vivo Immunogenicity Screening of Vaccine Candidate Antigen Combinations in Ethiopian Patients With Leishmaniasis
Leishmaniasis, Cutaneous, Leishmaniasis
Not yet recruitingPhase 2
Comparison of Intralesional Glucantime With and Without Fractional CO₂ Laser in Adults With Cutaneous Leishmaniasis
Cutaneous Leishminiasis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Local application pentostam, intra-lisional pentostam and fractional CO2 laser in people with Leishmaniasis, run by Tel-Aviv Sourasky Medical Center.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
scar appearance (time frame: At sixth month). 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 NCT03009422, which also lists 7 linked publications.
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 4 Jan 2017.