Parkinson's DiseasePhase 2ND0612/003NCT01883505
A Safety, Tolerability and Levodopa Pharmacokinetics Study of Repeated ND0612 in Parkinson's Disease Patients
A Phase 2 study testing ND0612 and Entacapone in people with Parkinson's Disease, run by NeuroDerm Ltd. at 3 sites in Israel.
Trial summary
This is a randomized, placebo-controlled, double-blind, 2-period study evaluating the safety and pharmacokinetics (PK) of ND0612 in Parkinson's disease (PD) patients on an optimized oral levodopa (LD) regimen and experiencing ≥2 h/day of OFF time. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- ND0612 and Entacapone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesIsrael
- Study dates
- 6 Jan 2014to 26 Apr 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with idiopathic PD whose diagnosis was confirmed by presence of at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) and lacking any other known or suspected cause of parkinsonism.
- Patients who experienced motor fluctuations averaging at least two hours daily in the "OFF" state during the waking hours (including morning akinesia), corresponding to the end-of-dose deterioration phenomenon ("wearing off") confirmed by the baseline home diaries.
- Modified Hoehn and Yahr stage < 5 in the "OFF" state.
- Patients who were taking optimized LD/decarboxylase inhibitor therapy (based on the investigator's judgment) that was stable for at least 14 days prior to baseline. Patients were to receive at least three daily doses of LD (which could include a bedtime dose) with at least three hours between doses.
- Patients treated with dopaminergic agonists and other anti-PD drugs were to be on stable doses for at least 30 days prior to baseline and those doses were to remain constant throughout the study period.
- Women who were postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential were to have a negative pregnancy test (beta human chorionic gonadotropin [hCG] serum) at screening.
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- Patients between the ages of 30 and 80.
- Patients willing and able to give informed consent.
- Patients and/or caregivers able to understand and follow instructions for use of SC delivery pump.
- Patients who demonstrated the ability to keep accurate diaries of PD symptoms (ON-OFF diaries).
Who cannot join
- Patients treated with controlled release formulation of LD/CD. (Note: Patients treated with Entacapone, Tolcapone, or Stalevo were allowed to participate in Period 1 but were excluded from Period 2 participation)
- Patients with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include gastrointestinal, cardiovascular, pulmonary, hepatic, renal, or metabolic diseases or malignancies as determined by medical history, physical exam, laboratory tests, or ECG.
- History of melanoma or significant skin disorders.
- Patients with significant cognitive impairment as defined by a MMSE score of < 25.
- Patients treated with dopaminergic agonists, anticholinergics, monoamine oxidase (MAO)-B inhibitors, or antipsychotics that need dose adjustment in the 30 days prior to Study Baseline.
- Patients with clinically significant psychiatric illness, including major depression (according to Diagnostic and Statistical Manual of Mental Disorders [DSM] IV criteria for major depressive episode) or other problems that might compromise their ability to provide consent or participate fully in the study.
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- Patients with a history of alcohol or substance abuse within the past two years.
- Patients who have taken experimental medications within 60 days prior to baseline.
- Patients who have undergone a neurosurgical intervention for PD (e.g. pallidotomy, thalamotomy, transplantation, or deep brain stimulation procedures).
- Patients with severe disabling dyskinesias.
- Patients with hearing, visual or motor impairments that prevent them from using the pump or reacting effectively to errors.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Hadassah Medical Center
Jerusalem
Rabin Medical Center
Petah Tikva
Tel Aviv Medical Center
Tel Aviv
About this study
Official title: A Phase IIa Multicenter, Randomized, Double-blind, Placebo-controlled Study Followed by an Open-label Period, to Evaluate the Safety, Tolerability, and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations, Administered With Repeated Subcutaneous ND0612
This is a randomized, placebo-controlled, double-blind, 2-period study evaluating the safety and pharmacokinetics (PK) of ND0612 in Parkinson's disease (PD) patients on an optimized oral levodopa (LD) regimen and experiencing ≥2 h/day of OFF time. Safety and tolerability, PK profile, pump usability, and the potential clinical effect of ND0612 will be explored in subjects with PD and motor fluctuations.
Read the detailed description
During Period 1, patients continued on their current standard of care (SoC) levodopa/carbidopa (LD/CD) and were randomized at 2:1 ratio to 14 days of adjunct treatment with ND0612 (daily LD/CD dose of 270/63 mg) or placebo infusion. During Period 2, patients were randomized to receive 7 days open-label treatment with ND0612 or ND0612 plus oral entacapone. Patients then entered a 4-week safety follow-up period.
- Conditions
- Parkinson's Disease
- Being tested
- ND0612, Placebo, Entacapone
- Keywords
- Motor fluctuations, levodopa pharmacokinetics, levodopa and carbidopa solution, continuous subcutaneous delivery, ambulatory infusion pump
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ND0612Drug
Also called Levodopa and carbidopa SC solution
Subcutaneous infusion via CRONO ND pump
PlaceboDrug
Also called Saline
Subcutaneous infusion via CRONO ND pump
EntacaponeDrug
200 mg oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Period 1. ND0612 | Experimental | A 24h SC infusion of levodopa/carbidopa 270/63 mg daily in addition to the current standard of care treatment for 14 days Receives: Drug: ND0612 |
| Period 1. Placebo | Placebo comparator | A 24h SC infusion of saline in addition to the current standard of care treatment for 14 days Receives: Drug: Placebo |
| Period 2. ND0612 | Experimental | A 24h SC infusion of levodopa/carbidopa 270/63 mg daily in addition to the current standard of care treatment for 7 days Receives: Drug: ND0612 |
| Period 2. ND0612 + Entacapone | Experimental | A 24h SC infusion of levodopa/carbidopa 270/63 mg daily in addition to the current standard of care treatment + Entacapone 200 mg 3 times/day (every 6 hours during waking hours) for 7 days Receives: Drug: ND0612; Drug: Entacapone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Dermal Rating Score: Draize Score
Local safety of the infusion sites was comprehensively assessed approximately one hour after removal of the SC pump. Draize score is the sum of the erythema and eschar formation plus edema scores with 0 meaning no and 8 indicating the most severe erythema, eschar, and edema formation. The maximum dermal rating score was assessed in Period 1.
Measured: 14 days (Period 1)
Maximum Dermal Rating Score: Erythema and Eschar Formation
Local safety of the infusion sites was comprehensively assessed approximately one hour after removal of the SC pump. Erythema was evaluated via the Draize score on a scale of 0 to 4, with 0 meaning no erythema to a maximum score of 4 representing the most severe erythema (beet redness to eschar formation). The maximum dermal rating score was assessed in Period 1.
Measured: 14 days (Period 1)
Maximum Dermal Rating Score: Edema
Local safety of the infusion sites was comprehensively assessed approximately one hour after removal of the SC pump. Edema was evaluated via the Draize score on a scale of 0 to 4, with 0 meaning no edema to a maximum score of 4 representing the most severe edema (raised more than 1 mm and extending beyond the area of exposure). The maximum dermal rating score was assessed in Period 1.
Measured: 14 days (Period 1)
Maximum Dermal Rating Score: Presence of Nodules
Local safety of the infusion sites was comprehensively assessed approximately one hour after removal of the SC pump. Evaluated via a scale of 0 to 3, with 0 meaning no nodule to a score of 3 representing severe (> 1 cm). The maximum dermal rating score was assessed in Period 1.
Measured: 14 days (Period 1)
Maximum Dermal Rating Score: Pruritus
Local safety of the infusion sites was comprehensively assessed approximately one hour after removal of the SC pump. Evaluated on a scale of 0 to 3, with 0 meaning no pruritus to a maximum score of 3 representing severe pruritus. The maximum dermal rating score was assessed in Period 1.
Measured: 14 days (Period 1)
Maximum Dermal Rating Score: Staining
Local safety of the infusion sites was comprehensively assessed approximately one hour after removal of the SC pump. The presence of staining at the infusion site was evaluated via a scale of 0 to 3, with 0 meaning none to a score of 3 representing severe. The maximum dermal rating score was assessed in Period 1.
Measured: 14 days (Period 1)
Maximum Dermal Rating Score: Pain
Local safety of the infusion sites was comprehensively assessed approximately one hour after removal of the SC pump. Pain score was evaluated with a visual analog scale (VAS). The VAS was a horizontal line, 100 mm in length, anchored by word descriptors at each end; "no pain" = 0 mm to "very severe pain" = 100 mm. The patient marked on the line the point that they felt represented their current state. The maximum dermal rating score was assessed in Period 1.
Measured: 14 days (Period 1)
Total Oral LD Dose
Total oral levodopa dose during PK sampling day
Measured: Day 15 (Period 1) and Day 22 (Period 2)
LD Cmin
The lowest plasma concentration (Cmin) measured during a sampling period. Samples collected at 2 h and 1 h prior to the first morning oral LD dose, and every 30 min for 2 h then hourly until 10 h.
Measured: Day 15 (Period 1) and Day 22 (Period 2)
LD Cmax
Maximum observed levodopa plasma concentration (Cmax). Samples collected at 2 h and 1 h prior to the first morning oral LD dose, and every 30 min for 2 h then hourly until 10 h.
Measured: Day 15 (Period 1) and Day 22 (Period 2)
LD AUC (0-10h)
Area under the concentration-time curve (AUC) until 10 h. Samples collected at 2 h and 1 h prior to the first morning oral LD dose, and every 30 min for 2 h then hourly until 10 h.
Measured: Day 15 (Period 1) and Day 22 (Period 2)
Time LD Concentration >1000 ng/mL
Time LD plasma concentrations were maintained above 1000 ng/mL. Samples collected at 2 h and 1 h prior to the first morning oral LD dose, and every 30 min for 2 h then hourly until 10 h.
Measured: Day 15 (Period 1) and Day 22 (Period 2)
LD Concentration FI
LD plasma concentration Fluctuation index (FI) is a pharmacokinetic parameter defined as [Cmax-Cmin]/Caverage. Samples collected at 2 h and 1 h prior to the first morning oral LD dose, and every 30 min for 2 h then hourly until 10 h. Lower values are considered better to maintain the clinical response.
Measured: Day 15 (Period 1) and Day 22 (Period 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study start6 Jan 2014
- Primary completion26 Apr 2015
- Study completion26 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arms in Period 1 (14 days, randomized double-blind) followed by 2 arms in Period 2 (7 days, randomized open-label)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroDerm Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, NeuroDerm Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883505
- Sponsor's protocol ID
- ND0612/003
- Acronym
- ND0612/003
- Status last verified
- Jul 2026
- First submitted
- 9 Jun 2013
- Last updated
- 9 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Multicenter, Randomized, Double-blind, Placebo-controlled Study Followed by an Open-label Period, to Evaluate the Safety, Tolerability, and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations, Administered With Repeated Subcutaneous ND0612
- ClinicalTrials.gov ID
- NCT01883505
- Acronym / sponsor ID
- ND0612/003 / ND0612/003
- Conditions
- Parkinson's Disease
- Keywords
- Motor fluctuations, levodopa pharmacokinetics, levodopa and carbidopa solution, continuous subcutaneous delivery, ambulatory infusion pump
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NeuroDerm Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2014 (actual)
- Primary completion
- 26 Apr 2015 (actual)
- Study completion
- 26 Apr 2015 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Posted 9 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, placebo-controlled, double-blind, 2-period study evaluating the safety and pharmacokinetics (PK) of ND0612 in Parkinson's disease (PD) patients on an optimized oral levodopa (LD) regimen and experiencing ≥2 h/day of OFF time. Safety and tolerability, PK profile, pump usability, and the potential clinical effect of ND0612 will be explored in subjects with PD and motor fluctuations.
Detailed description
During Period 1, patients continued on their current standard of care (SoC) levodopa/carbidopa (LD/CD) and were randomized at 2:1 ratio to 14 days of adjunct treatment with ND0612 (daily LD/CD dose of 270/63 mg) or placebo infusion. During Period 2, patients were randomized to receive 7 days open-label treatment with ND0612 or ND0612 plus oral entacapone. Patients then entered a 4-week safety follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 2 arms in Period 1 (14 days, randomized double-blind) followed by 2 arms in Period 2 (7 days, randomized open-label)
| Arm | Type | Receives |
|---|---|---|
| Period 1. ND0612 | Experimental | Drug: ND0612A 24h SC infusion of levodopa/carbidopa 270/63 mg daily in addition to the current standard of care treatment for 14 days |
| Period 1. Placebo | Placebo comparator | Drug: PlaceboA 24h SC infusion of saline in addition to the current standard of care treatment for 14 days |
| Period 2. ND0612 | Experimental | Drug: ND0612A 24h SC infusion of levodopa/carbidopa 270/63 mg daily in addition to the current standard of care treatment for 7 days |
| Period 2. ND0612 + Entacapone | Experimental | Drug: ND0612, Drug: EntacaponeA 24h SC infusion of levodopa/carbidopa 270/63 mg daily in addition to the current standard of care treatment + Entacapone 200 mg 3 times/day (every 6 hours during waking hours) for 7 days |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women with idiopathic PD whose diagnosis was confirmed by presence of at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) and lacking any other known or suspected cause of parkinsonism.
- Patients who experienced motor fluctuations averaging at least two hours daily in the "OFF" state during the waking hours (including morning akinesia), corresponding to the end-of-dose deterioration phenomenon ("wearing off") confirmed by the baseline home diaries.
- Modified Hoehn and Yahr stage < 5 in the "OFF" state.
- Patients who were taking optimized LD/decarboxylase inhibitor therapy (based on the investigator's judgment) that was stable for at least 14 days prior to baseline. Patients were to receive at least three daily doses of LD (which could include a bedtime dose) with at least three hours between doses.
- Patients treated with dopaminergic agonists and other anti-PD drugs were to be on stable doses for at least 30 days prior to baseline and those doses were to remain constant throughout the study period.
Key exclusion criteria (11 listed)
- Patients treated with controlled release formulation of LD/CD. (Note: Patients treated with Entacapone, Tolcapone, or Stalevo were allowed to participate in Period 1 but were excluded from Period 2 participation)
- Patients with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include gastrointestinal, cardiovascular, pulmonary, hepatic, renal, or metabolic diseases or malignancies as determined by medical history, physical exam, laboratory tests, or ECG.
- History of melanoma or significant skin disorders.
- Patients with significant cognitive impairment as defined by a MMSE score of < 25.
- Patients treated with dopaminergic agonists, anticholinergics, monoamine oxidase (MAO)-B inhibitors, or antipsychotics that need dose adjustment in the 30 days prior to Study Baseline.
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 |
|---|---|---|
| ND0612Also: Levodopa and carbidopa SC solutionSubcutaneous infusion via CRONO ND pump | Drug | Period 1. ND0612, Period 2. ND0612, Period 2. ND0612 + Entacapone |
| PlaceboAlso: SalineSubcutaneous infusion via CRONO ND pump | Drug | Period 1. Placebo |
| Entacapone200 mg oral tablet | Drug | Period 2. ND0612 + Entacapone |
Primary outcome
Maximum Dermal Rating Score: Draize Score
Time frame: 14 days (Period 1)
Local safety of the infusion sites was comprehensively assessed approximately one hour after removal of the SC pump. Draize score is the sum of the erythema and eschar formation plus edema scores with 0 meaning no and 8 indicating the most severe erythema, eschar, and edema formation. The maximum dermal rating score was assessed in Period 1.
Maximum Dermal Rating Score: Erythema and Eschar Formation
Time frame: 14 days (Period 1)
Local safety of the infusion sites was comprehensively assessed approximately one hour after removal of the SC pump. Erythema was evaluated via the Draize score on a scale of 0 to 4, with 0 meaning no erythema to a maximum score of 4 representing the most severe erythema (beet redness to eschar formation). The maximum dermal rating score was assessed in Period 1.
Maximum Dermal Rating Score: Edema
Time frame: 14 days (Period 1)
Local safety of the infusion sites was comprehensively assessed approximately one hour after removal of the SC pump. Edema was evaluated via the Draize score on a scale of 0 to 4, with 0 meaning no edema to a maximum score of 4 representing the most severe edema (raised more than 1 mm and extending beyond the area of exposure). The maximum dermal rating score was assessed in Period 1.
Maximum Dermal Rating Score: Presence of Nodules
Time frame: 14 days (Period 1)
Local safety of the infusion sites was comprehensively assessed approximately one hour after removal of the SC pump. Evaluated via a scale of 0 to 3, with 0 meaning no nodule to a score of 3 representing severe (> 1 cm). The maximum dermal rating score was assessed in Period 1.
Maximum Dermal Rating Score: Pruritus
Time frame: 14 days (Period 1)
Local safety of the infusion sites was comprehensively assessed approximately one hour after removal of the SC pump. Evaluated on a scale of 0 to 3, with 0 meaning no pruritus to a maximum score of 3 representing severe pruritus. The maximum dermal rating score was assessed in Period 1.
Maximum Dermal Rating Score: Staining
Time frame: 14 days (Period 1)
Local safety of the infusion sites was comprehensively assessed approximately one hour after removal of the SC pump. The presence of staining at the infusion site was evaluated via a scale of 0 to 3, with 0 meaning none to a score of 3 representing severe. The maximum dermal rating score was assessed in Period 1.
Maximum Dermal Rating Score: Pain
Time frame: 14 days (Period 1)
Local safety of the infusion sites was comprehensively assessed approximately one hour after removal of the SC pump. Pain score was evaluated with a visual analog scale (VAS). The VAS was a horizontal line, 100 mm in length, anchored by word descriptors at each end; "no pain" = 0 mm to "very severe pain" = 100 mm. The patient marked on the line the point that they felt represented their current state. The maximum dermal rating score was assessed in Period 1.
Total Oral LD Dose
Time frame: Day 15 (Period 1) and Day 22 (Period 2)
Total oral levodopa dose during PK sampling day
LD Cmin
Time frame: Day 15 (Period 1) and Day 22 (Period 2)
The lowest plasma concentration (Cmin) measured during a sampling period. Samples collected at 2 h and 1 h prior to the first morning oral LD dose, and every 30 min for 2 h then hourly until 10 h.
LD Cmax
Time frame: Day 15 (Period 1) and Day 22 (Period 2)
Maximum observed levodopa plasma concentration (Cmax). Samples collected at 2 h and 1 h prior to the first morning oral LD dose, and every 30 min for 2 h then hourly until 10 h.
LD AUC (0-10h)
Time frame: Day 15 (Period 1) and Day 22 (Period 2)
Area under the concentration-time curve (AUC) until 10 h. Samples collected at 2 h and 1 h prior to the first morning oral LD dose, and every 30 min for 2 h then hourly until 10 h.
Time LD Concentration >1000 ng/mL
Time frame: Day 15 (Period 1) and Day 22 (Period 2)
Time LD plasma concentrations were maintained above 1000 ng/mL. Samples collected at 2 h and 1 h prior to the first morning oral LD dose, and every 30 min for 2 h then hourly until 10 h.
LD Concentration FI
Time frame: Day 15 (Period 1) and Day 22 (Period 2)
LD plasma concentration Fluctuation index (FI) is a pharmacokinetic parameter defined as [Cmax-Cmin]/Caverage. Samples collected at 2 h and 1 h prior to the first morning oral LD dose, and every 30 min for 2 h then hourly until 10 h. Lower values are considered better to maintain the clinical response.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Senior Medical Director study director
NeuroDerm Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ND0612 and Entacapone in people with Parkinson's Disease, run by NeuroDerm Ltd. at 3 sites in Israel.
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 10 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Dermal Rating Score: Draize Score (time frame: 14 days (Period 1)). The study lists 13 primary outcomes in all. 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 9 Jul 2026.