Lepromatous LeprosyNCT02085317
Microcirculatory Impairment in Patients With Leprosy
A study testing acetylcholine Iontophoresis and sodium nitroprusside Iontophoresis in people with Lepromatous Leprosy, run by Curt Treu.
Trial summary
In this study the investigators have aimed to evaluate morphology and reactivity of cutaneous microcirculation in patients with lepromatous leprosy. Ten patients, without any other comorbidity were compared to ten controls without leprosy or any other comorbidity, using the Cytoscan® [orthogonal polarization spectral… Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lepromatous Leprosy
- What is being tested?
- acetylcholine Iontophoresis and sodium nitroprusside Iontophoresis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Feb 2010
- 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 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male patients with only lepromatous leprosy in treatment
- age between 20 and 60
- body mass index (BMI) between 18 and 35 kg/m2
- ability to follow given directions and to attend assessments and
- Fitzpatrick's Phototype I-IV
Who cannot join
- females
- arterial hypertension
- diabetes mellitus
- BMI greater than 35 kg/m2
- collagenosis
- past or present history of smoking
- age under 20 and over 60 years.
About this study
Official title: Observation of Microcirculation Impairment in Patients With Lepromatous Leprosy Using Orthogonal Polarization Spectral (OPS) Imaging and Laser Doppler Iontophoresis
In this study the investigators have aimed to evaluate morphology and reactivity of cutaneous microcirculation in patients with lepromatous leprosy. Ten patients, without any other comorbidity were compared to ten controls without leprosy or any other comorbidity, using the Cytoscan® [orthogonal polarization spectral (OPS) imaging], Fourier analysis of laser Doppler signal to evaluate vasomotion (rhythmic spontaneous oscillation of arteriolar diameter) and laser Doppler flowmetry associated to iontophoresis of vasoactive substances (acetylcholine and sodium nitroprusside).
Read the detailed description
Evaluation with OPS:
After acclimatization, the microcirculation of patients and controls was assessed by OPS in three different points, according to criteria recommended by De Backer(De Backer et al., 2007). Images were recorded for 10 seconds at each point and evaluated afterwards using Cap-Image v7.2software.
Evaluation with laser-Doppler flowmetry (LDF):
Skin blood perfusion was measured in conventional perfusion units (PU) by means of a LDF apparatus (Periflux PF4, Perimed, Stockholm, Sweden), equipped with a non-heated probe (PF408), fixed to the medial surface of the right forearm. Laser characteristics were: 780 nm wavelength, 10-19 kHz bandwidth, 0.1 s time constant and 32 Hz sampling frequency. Skin blood perfusion was expressed in conventional perfusion units (PU: 1 PU=10 mV) and LD signal was recorded continuously by an interfaced computer (Sony VaioVGN-CR160A) equipped with Perisoft dedicated software. Exams were performed in two steps:
First, to register vasomotion, a probe (Probe 481-1: Single Iontophoresis Probe - Perimed, Stockholm, Sweden) was placed, after the skin was cleaned with a wipe of 70° alcohol and left to air dry, in the dorsal face of the distal phalanx of the 2nd finger. The probes were positioned at least 10 cm apart, avoiding superficial veins and broken skin areas. This probe may be used for both vasomotion and iontophoresis. Basal blood perfusion was continuously recorded during 20 min. Skin temperature was continuously measured.
To avoid residual effects of previously used drugs, the probe position for combined iontophoresis and LDF recordings were placed in untreated fingers [2nd for acetylcholine (Ach) and 3nd for sodium nitroprusside (SNP)] after each measurement .
Using a protocol similar to the one developed by Rossi and co-workers (Rossi et al., 2008), ACh (Acetylcholine - Sigma-Aldrich, St. Louis, USA) was delivered by 9 iontophoretic pulses of 0.1 mA for 20 s with 60 s interval between pulses using a drug delivery electrode filled with 0.1 ml of 1% ACh solution, attached to the dorsal aspect of the second left finger by a double-sided adhesive disc. After Ach, SNP (Nipride® 10mg/ml - Biolab, São Paulo, Brazil) was delivered by 7 iontophoretic pulses of 0.2 mA for 20 s with 180 s interval between pulses using another drug delivery electrode filled with 0.1 ml of 1% SNP solution, attached to the dorsal aspect of the third left finger. In both situations, an indifferent electrode was attached on the dorsal aspect of the left hand. Endothelial-dependent and independent skin vasodilator response to each iontophoresis pulse was measured in PUs, as mean value during each interval from one pulse to the following one.
- Conditions
- Lepromatous Leprosy
- Being tested
- acetylcholine Iontophoresis, sodium nitroprusside Iontophoresis
- Keywords
- Microcirculation, Leprosy, Nervous system, Orthogonal polarization spectral (OPS) imaging, Laser Doppler flowmetry, Iontophoresis.
- Medical subject headings
- Leprosy, Lepromatous, Leprosy, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylcholine IontophoresisDrug
Using a protocol similar to the one developed by Rossi and co-workers (Rossi et al., 2008), ACh (Acetylcholine - Sigma-Aldrich, St. Louis, USA) was delivered by 9 iontophoretic pulses of 0.1 mA for 20 s with 60 s interval between pulses using a drug delivery electrode filled with 0.1 ml of 1% ACh solution, attached to the dorsal aspect of the second left finger by a double-sided adhesive disc.
sodium nitroprusside IontophoresisDrug
After Ach, SNP (Nipride® 10mg/ml - Biolab, São Paulo, Brazil) was delivered by 7 iontophoretic pulses of 0.2 mA for 20 s with 180 s interval between pulses using another drug delivery electrode filled with 0.1 ml of 1% SNP solution, attached to the dorsal aspect of the third left finger. In both situations, an indifferent electrode was attached on the dorsal aspect of the left hand. Endothelial-dependent and independent skin vasodilator response to each iontophoresis pulse was measured in PUs, as mean value during each interval from one pulse to the following one.
| Study group | Role | What they receive |
|---|---|---|
| Lepromatous Patients | Other | Composed of patients with lepromatous Leprosy acetylcholine Iontophoresis sodium nitroprusside Iontophoresis Receives: Drug: acetylcholine Iontophoresis; Drug: sodium nitroprusside Iontophoresis |
| Healthy Patients | Other | Composed of patients without any disease acetylcholine Iontophoresis sodium nitroprusside Iontophoresis Receives: Drug: acetylcholine Iontophoresis; Drug: sodium nitroprusside Iontophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laser-Doppler flowmetry
perfusion units (PU: 1 PU=10 mV)
Measured: 0 - 20 min.
Secondary outcomes (1)
Cytoscan
Using the Cystoscan, we have evaluated functional capillary density, diameter of the dermal papilla, capillary diameter, capillary handle diameter and capillary morphology
Measured: 0 - 5min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startMar 2006
- Primary completionNov 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lepromatous LeprosyStudies 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curt Treu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Curt Treu, Rio de Janeiro State University
- Investigators
- curt treu, PhD, Principal investigator, Rio de Janeiro State UniversityEliete Bouskela, PhD, Study director, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085317
- Sponsor's protocol ID
- Biovasc-1
- Status last verified
- Mar 2014
- First submitted
- 2 Mar 2014
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Microcirculation Impairment in Patients With Lepromatous Leprosy Using Orthogonal Polarization Spectral (OPS) Imaging and Laser Doppler Iontophoresis
- ClinicalTrials.gov ID
- NCT02085317
- Acronym / sponsor ID
- Biovasc-1
- Conditions
- Lepromatous Leprosy
- Keywords
- Microcirculation, Leprosy, Nervous system, Orthogonal polarization spectral (OPS) imaging, Laser Doppler flowmetry, Iontophoresis.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Curt TreuUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 12 Mar 2014 (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.
In this study the investigators have aimed to evaluate morphology and reactivity of cutaneous microcirculation in patients with lepromatous leprosy. Ten patients, without any other comorbidity were compared to ten controls without leprosy or any other comorbidity, using the Cytoscan® [orthogonal polarization spectral (OPS) imaging], Fourier analysis of laser Doppler signal to evaluate vasomotion (rhythmic spontaneous oscillation of arteriolar diameter) and laser Doppler flowmetry associated to iontophoresis of vasoactive substances (acetylcholine and sodium nitroprusside).
Detailed description
Evaluation with OPS:
After acclimatization, the microcirculation of patients and controls was assessed by OPS in three different points, according to criteria recommended by De Backer(De Backer et al., 2007). Images were recorded for 10 seconds at each point and evaluated afterwards using Cap-Image v7.2software.
Evaluation with laser-Doppler flowmetry (LDF):
Skin blood perfusion was measured in conventional perfusion units (PU) by means of a LDF apparatus (Periflux PF4, Perimed, Stockholm, Sweden), equipped with a non-heated probe (PF408), fixed to the medial surface of the right forearm. Laser characteristics were: 780 nm wavelength, 10-19 kHz bandwidth, 0.1 s time constant and 32 Hz sampling frequency. Skin blood perfusion was expressed in conventional perfusion units (PU: 1 PU=10 mV) and LD signal was recorded continuously by an interfaced computer (Sony VaioVGN-CR160A) equipped with Perisoft dedicated software. Exams were performed in two steps:
First, to register vasomotion, a probe (Probe 481-1: Single Iontophoresis Probe - Perimed, Stockholm, Sweden) was placed, after the skin was cleaned with a wipe of 70° alcohol and left to air dry, in the dorsal face of the distal phalanx of the 2nd finger. The probes were positioned at least 10 cm apart, avoiding superficial veins and broken skin areas. This probe may be used for both vasomotion and iontophoresis. Basal blood perfusion was continuously recorded during 20 min. Skin temperature was continuously measured.
To avoid residual effects of previously used drugs, the probe position for combined iontophoresis and LDF recordings were placed in untreated fingers [2nd for acetylcholine (Ach) and 3nd for sodium nitroprusside (SNP)] after each measurement .
Using a protocol similar to the one developed by Rossi and co-workers (Rossi et al., 2008), ACh (Acetylcholine - Sigma-Aldrich, St. Louis, USA) was delivered by 9 iontophoretic pulses of 0.1 mA for 20 s with 60 s interval between pulses using a drug delivery electrode filled with 0.1 ml of 1% ACh solution, attached to the dorsal aspect of the second left finger by a double-sided adhesive disc. After Ach, SNP (Nipride® 10mg/ml - Biolab, São Paulo, Brazil) was delivered by 7 iontophoretic pulses of 0.2 mA for 20 s with 180 s interval between pulses using another drug delivery electrode filled with 0.1 ml of 1% SNP solution, attached to the dorsal aspect of the third left finger. In both situations, an indifferent electrode was attached on the dorsal aspect of the left hand. Endothelial-dependent and independent skin vasodilator response to each iontophoresis pulse was measured in PUs, as mean value during each interval from one pulse to the following one.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lepromatous Patients | Other | Drug: acetylcholine Iontophoresis, Drug: sodium nitroprusside IontophoresisComposed of patients with lepromatous Leprosy acetylcholine Iontophoresis sodium nitroprusside Iontophoresis |
| Healthy Patients | Other | Drug: acetylcholine Iontophoresis, Drug: sodium nitroprusside IontophoresisComposed of patients without any disease acetylcholine Iontophoresis sodium nitroprusside Iontophoresis |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- male patients with only lepromatous leprosy in treatment
- age between 20 and 60
- body mass index (BMI) between 18 and 35 kg/m2
- ability to follow given directions and to attend assessments and
- Fitzpatrick's Phototype I-IV
Key exclusion criteria (7 listed)
- females
- arterial hypertension
- diabetes mellitus
- BMI greater than 35 kg/m2
- collagenosis
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 |
|---|---|---|
| acetylcholine IontophoresisUsing a protocol similar to the one developed by Rossi and co-workers (Rossi et al., 2008), ACh (Acetylcholine - Sigma-Aldrich, St. Louis, USA) was delivered by 9 iontophoretic pulses of 0.1 mA for 20 s with 60 s interval between pulses using a drug delivery electrode filled with 0.1 ml of 1% ACh solution, attached to the dorsal aspect of the second left finger by a double-sided adhesive disc. | Drug | Healthy Patients, Lepromatous Patients |
| sodium nitroprusside IontophoresisAfter Ach, SNP (Nipride® 10mg/ml - Biolab, São Paulo, Brazil) was delivered by 7 iontophoretic pulses of 0.2 mA for 20 s with 180 s interval between pulses using another drug delivery electrode filled with 0.1 ml of 1% SNP solution, attached to the dorsal aspect of the third left finger. In both situations, an indifferent electrode was attached on the dorsal aspect of the left hand. Endothelial-dependent and independent skin vasodilator response to each iontophoresis pulse was measured in PUs, as mean value during each interval from one pulse to the following one. | Drug | Healthy Patients, Lepromatous Patients |
Primary outcome
Laser-Doppler flowmetry
Time frame: 0 - 20 min.
perfusion units (PU: 1 PU=10 mV)
1 secondary outcome
Cytoscan
Time frame: 0 - 5min
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 Mar 2014.
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Leprosy, Hansen's Disease
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.
curt treu, PhD principal investigator
Rio de Janeiro State University
Eliete Bouskela, PhD study director
Rio de Janeiro State University
Questions about this trial
What is this clinical trial studying?
A study testing acetylcholine Iontophoresis and sodium nitroprusside Iontophoresis in people with Lepromatous Leprosy, run by Curt Treu.
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 7 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 Mar 2014. 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?
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?
Laser-Doppler flowmetry (time frame: 0 - 20 min.). 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 12 Mar 2014.