Atopic DermatitisPhase 2NCT00583895
Safety and Efficacy Study of ImCOOH Cream in Patients Suffering From Moderate Atopic Dermatitis
A Phase 2 study testing 10% ImCOOH cream in people with Atopic Dermatitis, run by Valletta Health B.V. at 1 site in Spain.
Trial summary
Atopic dermatitis is one of the most common skin diseases, with a lifetime prevalence of up to 20%, and an increasing number of cases. Although there are a variety of treatments the number of specific medications for treating this chronic disease is limited and often not helpful, especially in more severe cases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- 10% ImCOOH cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2007to Dec 2008
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged between 18 and 70 years, extremes included.
- Skin type I, II, III, or IV.
- Able to comply with protocol requirements.
- Informed Consent Form (ICF) signed voluntarily before the first trial-related activity.
- Nonsmoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection.
- Normal weight as defined by a Quetelet Index (Body Mass Index [BMI]: weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included.
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- Patients having atopic dermatitis according to the integrated list with criteria for atopic dermatitis.
- Comparative target areas: minimum 0.1% and maximum 2% of the total body surface area per target area with one site at the left limb and one site at the right limb. Both target areas should be located at the arms (armpits [axillas] are also allowed) or both target areas should be located at the hollows of the knee.
- Topical Atopic Dermatitis Severity Index (toADSI) score of at least 5 for both target areas and the severity of the 2 sites do not differ by more than 3 points.
- General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial.
Who cannot join
- Female subject of childbearing potential without use of effective birth control methods, or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period;
- Note: Estrogen based hormonal contraception may not be reliable when ImCOOH cream is applied, therefore to be eligible for this trial, women of childbearing potential should either:
- use a double barrier method to prevent pregnancy (i.e., using a condom with either diaphragm or cervical cap);
- use hormonal based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom);
- use an intrauterine device in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom);
- be only non-heterosexually active, practice heterosexual abstinence, or have a vasectomized partner (confirmed sterile).
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- Women with tubal ligation are required to use 1 non-hormonal contraceptive method.
- Women who are postmenopausal for at least 2 years, and women with total hysterectomy are considered of non-childbearing potential.
- A positive pregnancy test or breast feeding at screening.
- A positive HIV-1 or -2 test at trial screening.
- Hepatitis B infection (confirmed by hepatitis B surface antigen) or hepatitis C infection (confirmed by hepatitis C virus antibody) at trial screening.
- Having a target area that is hairy in such extent that in the investigator's opinion it could influence the application.
- Having a target area that is tattooed.
- Unable to take venous blood samples for pharmacokinetics (PK) outside the elbow fold (fossa cubitus) area in case both elbow folds are part of the target areas.
- Patients receiving radiation therapy, systemic therapy with cytostatics or immunosuppressive drugs within 24 weeks before the first application of trial medication.
- Patients receiving phototherapy or systemic therapy for atopic dermatitis within 4 weeks before the first application of trial medication.
- Patients receiving antibiotics or topical therapy for atopic dermatitis within 2 weeks before the first application of trial medication. However, once-daily use of 1% hydrocortisone acetate is allowed on all lesions with the exception of the test sites and emollients are allowed to be used liberally but not on the test sites.
- Patients taking antihistamines within 1 week before the first application of trial medication.
- Patients with any acute skin infection (superinfection or secondary impetiginisation).
- Any condition (including but not limited to alcohol and drug use), which in the opinion of the investigator could compromise the patient safety or compliance with trial procedures.
- Any history or currently active allergy such as but not limited to drug allergy, food allergy or hay fever.
- Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the trial medication administered in this trial.
- Participation in an investigational drug trial within 30 days prior to the first application of trial medication.
- Donation of blood or plasma in the 60 days preceding the first application of trial medication.
- Patients with the following laboratory abnormalities at screening:
- serum creatinine > 1.1 x ULN;
- hemoglobin ≤ 10.9 g/dL;
- platelet count grade ≤ 125 x 109/L;
- absolute neutrophil count ≤ 1.3 x 109/L;
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 1.25 x ULN;
- total bilirubin ≥ 1.1 x ULN;
- proteinuria or hematuria;
- any other moderate or severe laboratory abnormality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IIa, Randomized, Double-blind, Placebo-controlled, Intra-individual Left-right Limb Comparison Trial in 25 Patients With Moderate Atopic Dermatitis to Investigate the Efficacy, Local Irritation, Safety, Tolerability and Pharmacokinetics of Twice Daily Topical Applications With 10% ImCOOH Cream for 14 Days With an Additional Morning Application on Day 15.
Atopic dermatitis is one of the most common skin diseases, with a lifetime prevalence of up to 20%, and an increasing number of cases. Although there are a variety of treatments the number of specific medications for treating this chronic disease is limited and often not helpful, especially in more severe cases. In addition,most treatments may be used only for a limited period or are less effective in the long term (tachyphylaxis). The development of new compounds is mandatory for treatment of this often chronically recurring disease. The current trial will determine the efficacy, safety and tolerability of the endogenous compound imidazole-4-carboxylic acid (ImCOOH) administered as a topical cream twice daily for 14 days in patients with atopic dermatitis.
Read the detailed description
This is a Phase IIa, randomized, double-blind, placebo-controlled, intra-individual left-right limb comparison trial to investigate the efficacy, local irritation, safety, tolerability and pharmacokinetics of multiple topical applications of ImCOOH cream. The trial population will consist of 25 patients with moderate atopic dermatitis. Twenty patients will receive a hydrophilic cream containing 10% ImCOOH and a placebo cream randomized over both limbs twice daily for 14 days with an additional morning application on Day 15. Five patients will receive placebo cream on both limbs twice daily for 14 days with an additional morning application on Day 15. The creams will be applied on 2 comparative target areas (minimum 0.1% and maximum 2% of the total body surface area per target area), with one site at the left limb and one site at the right limb. The applied creams needs to be prevented from wiping off. Efficacy will be assessed until Day 15 and safety and tolerability will be monitored until 14 days after the last application.
Efficacy will be assessed by determining the Topical Atopic Dermatitis Severity Index (toADSI) score, and the Visual Analogue Scale for Pruritis (VAS) score for both target areas at screening, predose on Day 1 of treatment and on Days 2, 7, 9, 12 and 15 of treatment. In addition, color pictures of the target areas will be taken predose on Day 1 of treatment and on Days 7 and 15 of treatment. Finally the Eczema Area and Severity Index (EASI) score will be determined for both target areas, predose on Day 1 of treatment and on Days 7 and 15 of treatment.
Safety will be assessed by monitoring (S)AEs, performing clinical laboratory tests (hematology, biochemistry, urinalysis) and physical exams and by taking vital signs and recording ECGs on a regular basis.
For pharmacokinetic analysis, plasma concentrations of ImCOOH will be determined on Days 1 and 15 up to 12 hours postdose. In addition, the morning predose plasma concentration of ImCOOH will be determined on Days 2, 4, 7, 9, and 12. Full urinary output will be collected on Day 15 up to 12 hours postdose to determine the amount of unchanged ImCOOH excreted in urine. In the patients who received the placebo cream only, the endogenous ImCOOH concentrations in plasma and urine will be measured.
- Conditions
- Atopic Dermatitis
- Being tested
- 10% ImCOOH cream, Placebo
- Keywords
- dermatitis, atopic, ImCOOH, safety, tolerability, efficacy, pharmacokinetics
- Medical subject headings
- Dermatitis, Atopic, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% ImCOOH creamDrug
Twenty patients will receive a hydrophilic cream containing 10% ImCOOH and a placebo cream randomized over both limbs twice daily for 14 days with an additional morning application on Day 15.
PlaceboDrug
Five patients will receive placebo cream on both limbs twice daily for 14 days with an additional morning application on Day 15.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Twenty patients will receive a hydrophilic cream containing 10% ImCOOH and a placebo cream randomized over both limbs twice daily for 14 days with an additional morning application on Day 15. Receives: Drug: 10% ImCOOH cream |
| 2 | Placebo comparator | Five patients will receive placebo cream on both limbs twice daily for 14 days with an additional morning application on Day 15. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Topical Atopic Dermatitis Severity Index (toADSI) score
Measured: screening, predose on Day 1 and on Day 2, 7, 9 and 15
Visual Analogue Scale for Pruritis (VAS) score
Measured: Screening, Day 1 predose, Day 2, 7, 9, 12 and 15
Secondary outcomes (2)
Eczema Area and Severity Index (EASI) score
Measured: Day 1 predose, Day 7 and 15
ImCOOH plasma and urine concentrations
Measured: Day 1 and 15 (plasma) up to 12 hours postdose and predose on Day 2, 4, 7, 9 and 12. Day 15(urine) up to 12 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Recruitment problems; insufficient number of new recruits
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valletta Health B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jan D Bos, M.D., Ph.D, FRCP, Study chair, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583895
- Sponsor's protocol ID
- VAL-UOP-C201
- Status last verified
- Feb 2010
- First submitted
- 20 Dec 2007
- Last updated
- 1 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa, Randomized, Double-blind, Placebo-controlled, Intra-individual Left-right Limb Comparison Trial in 25 Patients With Moderate Atopic Dermatitis to Investigate the Efficacy, Local Irritation, Safety, Tolerability and Pharmacokinetics of Twice Daily Topical Applications With 10% ImCOOH Cream for 14 Days With an Additional Morning Application on Day 15.
- ClinicalTrials.gov ID
- NCT00583895
- Acronym / sponsor ID
- VAL-UOP-C201
- Conditions
- Atopic Dermatitis
- Keywords
- dermatitis, atopic, ImCOOH, safety, tolerability, efficacy, pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems; insufficient number of new recruits
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Valletta Health B.V.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 2 Jan 2008 (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.
Atopic dermatitis is one of the most common skin diseases, with a lifetime prevalence of up to 20%, and an increasing number of cases. Although there are a variety of treatments the number of specific medications for treating this chronic disease is limited and often not helpful, especially in more severe cases. In addition,most treatments may be used only for a limited period or are less effective in the long term (tachyphylaxis). The development of new compounds is mandatory for treatment of this often chronically recurring disease. The current trial will determine the efficacy, safety and tolerability of the endogenous compound imidazole-4-carboxylic acid (ImCOOH) administered as a topical cream twice daily for 14 days in patients with atopic dermatitis.
Detailed description
This is a Phase IIa, randomized, double-blind, placebo-controlled, intra-individual left-right limb comparison trial to investigate the efficacy, local irritation, safety, tolerability and pharmacokinetics of multiple topical applications of ImCOOH cream. The trial population will consist of 25 patients with moderate atopic dermatitis. Twenty patients will receive a hydrophilic cream containing 10% ImCOOH and a placebo cream randomized over both limbs twice daily for 14 days with an additional morning application on Day 15. Five patients will receive placebo cream on both limbs twice daily for 14 days with an additional morning application on Day 15. The creams will be applied on 2 comparative target areas (minimum 0.1% and maximum 2% of the total body surface area per target area), with one site at the left limb and one site at the right limb. The applied creams needs to be prevented from wiping off. Efficacy will be assessed until Day 15 and safety and tolerability will be monitored until 14 days after the last application.
Efficacy will be assessed by determining the Topical Atopic Dermatitis Severity Index (toADSI) score, and the Visual Analogue Scale for Pruritis (VAS) score for both target areas at screening, predose on Day 1 of treatment and on Days 2, 7, 9, 12 and 15 of treatment. In addition, color pictures of the target areas will be taken predose on Day 1 of treatment and on Days 7 and 15 of treatment. Finally the Eczema Area and Severity Index (EASI) score will be determined for both target areas, predose on Day 1 of treatment and on Days 7 and 15 of treatment.
Safety will be assessed by monitoring (S)AEs, performing clinical laboratory tests (hematology, biochemistry, urinalysis) and physical exams and by taking vital signs and recording ECGs on a regular basis.
For pharmacokinetic analysis, plasma concentrations of ImCOOH will be determined on Days 1 and 15 up to 12 hours postdose. In addition, the morning predose plasma concentration of ImCOOH will be determined on Days 2, 4, 7, 9, and 12. Full urinary output will be collected on Day 15 up to 12 hours postdose to determine the amount of unchanged ImCOOH excreted in urine. In the patients who received the placebo cream only, the endogenous ImCOOH concentrations in plasma and urine will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: 10% ImCOOH creamTwenty patients will receive a hydrophilic cream containing 10% ImCOOH and a placebo cream randomized over both limbs twice daily for 14 days with an additional morning application on Day 15. |
| 2 | Placebo comparator | Drug: PlaceboFive patients will receive placebo cream on both limbs twice daily for 14 days with an additional morning application on Day 15. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female aged between 18 and 70 years, extremes included.
- Skin type I, II, III, or IV.
- Able to comply with protocol requirements.
- Informed Consent Form (ICF) signed voluntarily before the first trial-related activity.
- Nonsmoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection.
Key exclusion criteria (33 listed)
- Female subject of childbearing potential without use of effective birth control methods, or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period;
- Note: Estrogen based hormonal contraception may not be reliable when ImCOOH cream is applied, therefore to be eligible for this trial, women of childbearing potential should either:
- Women with tubal ligation are required to use 1 non-hormonal contraceptive method.
- Women who are postmenopausal for at least 2 years, and women with total hysterectomy are considered of non-childbearing potential.
- A positive pregnancy test or breast feeding at screening.
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 |
|---|---|---|
| 10% ImCOOH creamTwenty patients will receive a hydrophilic cream containing 10% ImCOOH and a placebo cream randomized over both limbs twice daily for 14 days with an additional morning application on Day 15. | Drug | 1 |
| PlaceboFive patients will receive placebo cream on both limbs twice daily for 14 days with an additional morning application on Day 15. | Drug | 2 |
Primary outcome
Topical Atopic Dermatitis Severity Index (toADSI) score
Time frame: screening, predose on Day 1 and on Day 2, 7, 9 and 15
Visual Analogue Scale for Pruritis (VAS) score
Time frame: Screening, Day 1 predose, Day 2, 7, 9, 12 and 15
2 secondary outcomes
Eczema Area and Severity Index (EASI) score
Time frame: Day 1 predose, Day 7 and 15
ImCOOH plasma and urine concentrations
Time frame: Day 1 and 15 (plasma) up to 12 hours postdose and predose on Day 2, 4, 7, 9 and 12. Day 15(urine) up to 12 hours postdose
Results and safety
The study was stopped early (reason given: Recruitment problems; insufficient number of new recruits). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2010.
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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.
Jan D Bos, M.D., Ph.D, FRCP study chair
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10% ImCOOH cream in people with Atopic Dermatitis, run by Valletta Health B.V. at 1 site in Spain.
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 33 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: stopped early, as of the sponsor's last update on 1 Mar 2010. 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 Spain. 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?
The study was stopped early (reason given: Recruitment problems; insufficient number of new recruits). 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?
Topical Atopic Dermatitis Severity Index (toADSI) score (time frame: screening, predose on Day 1 and on Day 2, 7, 9 and 15). The study lists 2 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 1 Mar 2010.