Calmmax Cream on UP in CKD Patients.NCT02032537
Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus
A study testing Callmax cream application over affected skin in people with Calmmax Cream on UP in CKD Patients., run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced chronic kidney disease (CKD) and end-stage renal disease (ESRD). Calmmax is a new topical cream that was introduced recently by Calmmax Pharma, an Israeli pharmaceutical company developed a topical cream based on active plant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calmmax Cream on UP in CKD Patients.
- What is being tested?
- Callmax cream application over affected skin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2014to May 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of pruritus of >8 weeks duration.
- Severity score of pruritus ≥5 as defined by VAS
- Discontinuation of any medication with presumed antipruritic effects at least 1 week before the study (including Calmmax cream)
- Negative pregnancy test result for all participating women of childbearing age;
Who cannot join
- Known allergy to Calmmax cream
- Any acute illness
- Liver cirrhosis
- Active dermatological disorder other than UP
- Decompensated heart failure
- Inability to give informed consent
- Known poor adherence to medical recommendations
Trial locations and contacts
1 site in 1 country.
Israel1 site
Shaare Zedek Medical Center
Jerusalem, 91031
Itzchak Slotki, Dr, 97226555111, islotki@szmc.org.il
Linda Shavit, Dr
About this study
Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced chronic kidney disease (CKD) and end-stage renal disease (ESRD).
Calmmax is a new topical cream that was introduced recently by Calmmax Pharma, an Israeli pharmaceutical company developed a topical cream based on active plant extracts for treatment of skin inflammation. We intend to conduct a prospective, double blind, placebo controlled, randomized trial that will assess the therapeutic effect of Calmmax cream on UP in a cohort of CKD and ESRD patients.
- Conditions
- Calmmax Cream on UP in CKD Patients.
- Being tested
- Callmax cream application over affected skin, Placebo
- Keywords
- callmax cream, uremic pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Callmax cream application over affected skinDrug
Callmax cream application over affected skin Callmax cream or topical water containing emollient (placebo) will be applied by the patient on the affected skin area whenever the pruritus starts including night time. The frequency of application will be regulated by individual patients and increased according to pruritus severity.
PlaceboDrug
Topical water containing emollient (placebo) will be applied by the patient on the affected skin area whenever the pruritus starts including night time. The frequency of application will be regulated by individual patients and increased according to pruritus severity. The data on efficacy, duration of effect and frequency of application will be collected.during the study.
| Study group | Role | What they receive |
|---|---|---|
| Callmax cream | Active comparator | Not described Receives: Drug: Callmax cream application over affected skin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of UP measured by reduction of VAS by more than 50 percent from baseline score
Measured: 1 year
Secondary outcomes (1)
quality of life assessed by questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015 (estimated)
- Study completionMay 2016 (estimated)
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 Calmmax Cream on UP in CKD Patients.Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Shavit, Shaare Zedek Medical Center
- Investigators
- Itzchak Slotki, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032537
- Sponsor's protocol ID
- Shavit.ctil
- Status last verified
- Jan 2014
- First submitted
- 6 Jan 2014
- Last updated
- 10 Jan 2014
- Results posted
- No
Publications
Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
PubMed 33283264
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus
- ClinicalTrials.gov ID
- NCT02032537
- Acronym / sponsor ID
- Shavit.ctil
- Conditions
- Calmmax Cream on UP in CKD Patients.
- Keywords
- callmax cream, uremic pruritus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 10 Jan 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.
Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced chronic kidney disease (CKD) and end-stage renal disease (ESRD).
Calmmax is a new topical cream that was introduced recently by Calmmax Pharma, an Israeli pharmaceutical company developed a topical cream based on active plant extracts for treatment of skin inflammation. We intend to conduct a prospective, double blind, placebo controlled, randomized trial that will assess the therapeutic effect of Calmmax cream on UP in a cohort of CKD and ESRD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Callmax cream | Active comparator | Drug: Callmax cream application over affected skin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of pruritus of >8 weeks duration.
- Severity score of pruritus ≥5 as defined by VAS
- Discontinuation of any medication with presumed antipruritic effects at least 1 week before the study (including Calmmax cream)
- Negative pregnancy test result for all participating women of childbearing age;
Key exclusion criteria (7 listed)
- Known allergy to Calmmax cream
- Any acute illness
- Liver cirrhosis
- Active dermatological disorder other than UP
- Decompensated heart failure
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 |
|---|---|---|
| Callmax cream application over affected skinCallmax cream application over affected skin Callmax cream or topical water containing emollient (placebo) will be applied by the patient on the affected skin area whenever the pruritus starts including night time. The frequency of application will be regulated by individual patients and increased according to pruritus severity. | Drug | Callmax cream |
| PlaceboTopical water containing emollient (placebo) will be applied by the patient on the affected skin area whenever the pruritus starts including night time. The frequency of application will be regulated by individual patients and increased according to pruritus severity. The data on efficacy, duration of effect and frequency of application will be collected.during the study. | Drug | Placebo |
Primary outcome
Improvement of UP measured by reduction of VAS by more than 50 percent from baseline score
Time frame: 1 year
1 secondary outcome
quality of life assessed by questionnaire
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
- Derived from this study: PubMed 33283264Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
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.
Itzchak Slotki, MD principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Callmax cream application over affected skin in people with Calmmax Cream on UP in CKD Patients., run by Shaare Zedek Medical Center at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 10 Jan 2014. 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 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.
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?
Contact Linda Shavit, Dr (97226555111, lshavit@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of UP measured by reduction of VAS by more than 50 percent from baseline score (time frame: 1 year). 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 NCT02032537, 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 10 Jan 2014.