Atopic DermatitisPhase 2NCT01320579
Investigation of the Efficacy of 2.5% and 5% Cis-urocanic Acid in Patients With Moderate or Severe Atopic Dermatitis
A Phase 2 study testing Cis-UCA 2.5% emulsion cream, Cis-UCA 5% emulsion cream and Protopic® 0.1% ointment in people with Atopic Dermatitis, run by BioCis Pharma Ltd at 7 sites in Finland.
Trial summary
The purpose of this study is to evaluate dose response, safety, tolerability and efficacy of 2.5% and 5% cis-UCA in comparison to placebo and active comparator in the treatment of adult patients with moderate or severe chronic atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Cis-UCA 2.5% emulsion cream, Cis-UCA 5% emulsion cream and Protopic® 0.1% ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 7 sitesFinland
- Study dates
- Mar 2011to Jun 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained prior to any screening procedure
- Caucasian male or female patient
- At least 18 years of age
- Weight at least 45 kg
- Patient with moderate or severe chronic atopic dermatitis
- Good general health ascertained by medical history, physical examination and laboratory determinations, showing no signs of clinically significant findings, except chronic atopic dermatitis
- Negative pregnancy test (premenopausal female patient) at screening and use of adequate contraceptive measures (both male and female patients) throughout the study and 30 days after the last cis-UCA dose
Who cannot join
- History of other significant skin disease, or skin manifestations of allergic illness or other dermatologic condition, except chronic moderate or severe atopic dermatitis, that would interfere with the trial assessments or compromise the patient's safety according to the opinion of the Investigator
- Present symptoms of other skin diseases, except chronic atopic dermatitis, that could disturb the study assessment and evaluation of the skin
- Current use of any active systemic medication for chronic atopic dermatitis within one month
- Current use of active topical medication in the planned investigational area for chronic atopic dermatitis within two weeks
- History of a sunny holiday, UV-light therapy or solarium use within one month before beginning of study treatments, or planning such during the study or within 7 days after the study
- Allergy to cis-UCA, or any constituents of the placebo emulsion cream or any constituents of Protopic® ointment
Show all 15Show fewer
- History of any skin-related cancer
- Congenital or acquired immunodeficiency or ongoing therapy that cause immunosuppression
- Earlier participation in a clinical study performed with cis-UCA
- Any clinically significant laboratory test result
- Suspected current drug or alcohol abuse
- Clinically significant illness during the 4 weeks prior to the first dose administration
- Any other condition that in the opinion of the Investigator would interfere with the evaluation of the study results or constitute a health hazard for the patient
- Unwillingness or doubtful capacity to comply with the protocol
- Doubtful availability to complete the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Finland7 sites
Helsinki University Central Hospital, Skin and Allergy Hospital
Helsinki, 00200
Mehiläinen Medical Center Kuopio
Kuopio
Lohja Hospital, Clinic of Dermatology and Allergology
Lohja
FinnMedi Oy
Tampere, FI-33520
Mehiläinen Medical Center Turku
Turku
Pulssi Medical Center
Turku
Turku University Hospital, Department of Dermatology and Venereal Diseases
Turku
About this study
Official title: Phase II Study to Investigate the Properties of Topical Twice Daily Doses of 2.5% and 5% Cis-urocanic Acid in Comparison to Active Comparator 0.1% Protopic® for up to 28 Days in Patients With Moderate or Severe Atopic Dermatitis
The purpose of this study is to evaluate dose response, safety, tolerability and efficacy of 2.5% and 5% cis-UCA in comparison to placebo and active comparator in the treatment of adult patients with moderate or severe chronic atopic dermatitis.
Read the detailed description
This is a Phase II multi-centre, double-blinded, vehicle-controlled, repeated and multiple dose, study to evaluate dose response, safety, tolerability and efficacy of 2.5% and 5% cis-UCA compared to placebo, and investigator-blinded to compare the safety, tolerability and efficacy of cis-UCA to the active comparator Protopic® 0.1% in patients with moderate or severe chronic atopic dermatitis treated for up to 28 days.
The primary objective is to compare the efficacy of two different doses of cis-UCA (2.5% and 5%) with placebo for up to 28 days in adult patients with moderate or severe chronic atopic dermatitis to determine the dose of cis-UCA for further clinical development.
Secondary objectives are as follows:
- To evaluate safety and tolerability of cis-UCA after topical twice daily doses of 2.5% and 5% for up to 28 days in adult patients with moderate or severe chronic atopic dermatitis.
- To evaluate dose response after topical twice daily doses of 2.5% and 5% for up to 28 days in adult subjects with moderate or severe chronic atopic dermatitis.
- To compare the efficacy and safety of 2.5% and 5% of cis-UCA to the efficacy and safety of 0.1% Protopic® after topical twice daily doses for up to 28 days in adult patients with moderate or severe chronic atopic dermatitis
The key eligibility criteria are the following: patients with moderate or severe chronic atopic dermatitis, at least 18 years of age, with no current treatment for atopic dermatitis with active systemic medication or active topical treatment in the planned investigational area, and with no history of any significant disease that would affect the use of cis-UCA or comparator.
In total, up to 150 adult patients (both males and females; at least 20% of each gender) with moderate or severe chronic atopic dermatitis will be included in the study. Up to 36 adult patients (both males and females) will be included in each treatment arm.
- Conditions
- Atopic Dermatitis
- Being tested
- Cis-UCA 2.5% emulsion cream, Cis-UCA 5% emulsion cream, Placebo for cis-UCA emulsion cream, Protopic® 0.1% ointment
- Keywords
- atopic dermatitis, cis-urocanic acid
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cis-UCA 2.5% emulsion creamDrug
Also called Cis-UCA 2.5%
2.5% cis-UCA in emulsion cream base twice daily, amount of a fingertip per one hand (i.e. palm + thumb + fingers) area, applied topically as a thin layer on the affected skin area of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area)
Cis-UCA 5% emulsion creamDrug
Also called Cis-UCA 5%
5% cis-UCA in emulsion cream base twice daily, amount of a fingertip per one hand (i.e. palm + thumb + fingers) area, applied topically as a thin layer on the affected skin area of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area)
Placebo for cis-UCA emulsion creamDrug
Also called Placebo
The placebo for cis-UCA product (emulsion cream base) twice daily, amount of a fingertip per one hand area applied topically as a thin layer on the affected skin area on of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area).
Protopic® 0.1% ointmentDrug
Also called Protopic®
0.1% Protopic® twice daily, amount of a fingertip per one hand area applied topically as a thin layer on the affected skin area of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area).
| Study group | Role | What they receive |
|---|---|---|
| Group 2 Cis-UCA 5% emulsion cream | Experimental | Not described Receives: Drug: Cis-UCA 5% emulsion cream |
| Group 3 Placebo cis-UCA emulsion cream | Placebo comparator | Not described Receives: Drug: Placebo for cis-UCA emulsion cream |
| Group 4 Protopic® 0.1% ointment | Active comparator | Not described Receives: Drug: Protopic® 0.1% ointment |
| Group 1 Cis-UCA 2.5% emulsion cream | Experimental | Not described Receives: Drug: Cis-UCA 2.5% emulsion cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Skin Assessment of erythema, oedema/papulation, oozing/crusts, excoriations, and lichenification
Measured: 37 days
Secondary outcomes (4)
Skin Erythema measurement
Measured: 37 days
Transepidermal Water Loss (TEWL) measurement
Measured: 37 days
Visual Analogue Scale (VAS) assessment for itching (pruritus) of the treatment area
Measured: 37 days
Physician Global Assessment (PGA)
Measured: 37 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCis Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sakari Reitamo, Professor, Principal investigator, Helsinki University Central Hospital, Skin and Allergy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320579
- Sponsor's protocol ID
- CL09002
- Other IDs
- 2010-023543-15
- Status last verified
- Jun 2012
- First submitted
- 21 Mar 2011
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. doi: 10.1056/NEJMra074081. No abstract available.
PubMed 18385500Cork MJ, Danby SG, Vasilopoulos Y, Hadgraft J, Lane ME, Moustafa M, Guy RH, Macgowan AL, Tazi-Ahnini R, Ward SJ. Epidermal barrier dysfunction in atopic dermatitis. J Invest Dermatol. 2009 Aug;129(8):1892-908. doi: 10.1038/jid.2009.133. Epub 2009 Jun 4.
PubMed 19494826De Fabo EC, Noonan FP. Mechanism of immune suppression by ultraviolet irradiation in vivo. I. Evidence for the existence of a unique photoreceptor in skin and its role in photoimmunology. J Exp Med. 1983 Jul 1;158(1):84-98. doi: 10.1084/jem.158.1.84.
PubMed 6223114Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. doi: 10.1159/000247298.
PubMed 8435513Hanifin JM, Reed ML; Eczema Prevalence and Impact Working Group. A population-based survey of eczema prevalence in the United States. Dermatitis. 2007 Jun;18(2):82-91. doi: 10.2310/6620.2007.06034.
PubMed 17498413Rajka G, Langeland T. Grading of the severity of atopic dermatitis. Acta Derm Venereol Suppl (Stockh). 1989;144:13-4. doi: 10.2340/000155551441314.
PubMed 2800895Wolkerstorfer A, de Waard van der Spek FB, Glazenburg EJ, Mulder PG, Oranje AP. Scoring the severity of atopic dermatitis: three item severity score as a rough system for daily practice and as a pre-screening tool for studies. Acta Derm Venereol. 1999 Sep;79(5):356-9. doi: 10.1080/000155599750010256.
PubMed 10494710Peltonen JM, Pylkkanen L, Jansen CT, Volanen I, Lehtinen T, Laihia JK, Leino L. Three randomised phase I/IIa trials of 5% cis-urocanic acid emulsion cream in healthy adult subjects and in patients with atopic dermatitis. Acta Derm Venereol. 2014 Jul;94(4):415-20. doi: 10.2340/00015555-1735.
PubMed 24284985
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Investigate the Properties of Topical Twice Daily Doses of 2.5% and 5% Cis-urocanic Acid in Comparison to Active Comparator 0.1% Protopic® for up to 28 Days in Patients With Moderate or Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01320579
- Acronym / sponsor ID
- CL09002
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, cis-urocanic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- BioCis Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 22 Mar 2011 (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 purpose of this study is to evaluate dose response, safety, tolerability and efficacy of 2.5% and 5% cis-UCA in comparison to placebo and active comparator in the treatment of adult patients with moderate or severe chronic atopic dermatitis.
Detailed description
This is a Phase II multi-centre, double-blinded, vehicle-controlled, repeated and multiple dose, study to evaluate dose response, safety, tolerability and efficacy of 2.5% and 5% cis-UCA compared to placebo, and investigator-blinded to compare the safety, tolerability and efficacy of cis-UCA to the active comparator Protopic® 0.1% in patients with moderate or severe chronic atopic dermatitis treated for up to 28 days.
The primary objective is to compare the efficacy of two different doses of cis-UCA (2.5% and 5%) with placebo for up to 28 days in adult patients with moderate or severe chronic atopic dermatitis to determine the dose of cis-UCA for further clinical development.
Secondary objectives are as follows:
- To evaluate safety and tolerability of cis-UCA after topical twice daily doses of 2.5% and 5% for up to 28 days in adult patients with moderate or severe chronic atopic dermatitis.
- To evaluate dose response after topical twice daily doses of 2.5% and 5% for up to 28 days in adult subjects with moderate or severe chronic atopic dermatitis.
- To compare the efficacy and safety of 2.5% and 5% of cis-UCA to the efficacy and safety of 0.1% Protopic® after topical twice daily doses for up to 28 days in adult patients with moderate or severe chronic atopic dermatitis
The key eligibility criteria are the following: patients with moderate or severe chronic atopic dermatitis, at least 18 years of age, with no current treatment for atopic dermatitis with active systemic medication or active topical treatment in the planned investigational area, and with no history of any significant disease that would affect the use of cis-UCA or comparator.
In total, up to 150 adult patients (both males and females; at least 20% of each gender) with moderate or severe chronic atopic dermatitis will be included in the study. Up to 36 adult patients (both males and females) will be included in each treatment arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 2 Cis-UCA 5% emulsion cream | Experimental | Drug: Cis-UCA 5% emulsion cream |
| Group 3 Placebo cis-UCA emulsion cream | Placebo comparator | Drug: Placebo for cis-UCA emulsion cream |
| Group 4 Protopic® 0.1% ointment | Active comparator | Drug: Protopic® 0.1% ointment |
| Group 1 Cis-UCA 2.5% emulsion cream | Experimental | Drug: Cis-UCA 2.5% emulsion cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent obtained prior to any screening procedure
- Caucasian male or female patient
- At least 18 years of age
- Weight at least 45 kg
- Patient with moderate or severe chronic atopic dermatitis
Key exclusion criteria (15 listed)
- History of other significant skin disease, or skin manifestations of allergic illness or other dermatologic condition, except chronic moderate or severe atopic dermatitis, that would interfere with the trial assessments or compromise the patient's safety according to the opinion of the Investigator
- Present symptoms of other skin diseases, except chronic atopic dermatitis, that could disturb the study assessment and evaluation of the skin
- Current use of any active systemic medication for chronic atopic dermatitis within one month
- Current use of active topical medication in the planned investigational area for chronic atopic dermatitis within two weeks
- History of a sunny holiday, UV-light therapy or solarium use within one month before beginning of study treatments, or planning such during the study or within 7 days after the study
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 |
|---|---|---|
| Cis-UCA 2.5% emulsion creamAlso: Cis-UCA 2.5%2.5% cis-UCA in emulsion cream base twice daily, amount of a fingertip per one hand (i.e. palm + thumb + fingers) area, applied topically as a thin layer on the affected skin area of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area) | Drug | Group 1 Cis-UCA 2.5% emulsion cream |
| Cis-UCA 5% emulsion creamAlso: Cis-UCA 5%5% cis-UCA in emulsion cream base twice daily, amount of a fingertip per one hand (i.e. palm + thumb + fingers) area, applied topically as a thin layer on the affected skin area of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area) | Drug | Group 2 Cis-UCA 5% emulsion cream |
| Placebo for cis-UCA emulsion creamAlso: PlaceboThe placebo for cis-UCA product (emulsion cream base) twice daily, amount of a fingertip per one hand area applied topically as a thin layer on the affected skin area on of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area). | Drug | Group 3 Placebo cis-UCA emulsion cream |
| Protopic® 0.1% ointmentAlso: Protopic®0.1% Protopic® twice daily, amount of a fingertip per one hand area applied topically as a thin layer on the affected skin area of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area). | Drug | Group 4 Protopic® 0.1% ointment |
Primary outcome
Clinical Skin Assessment of erythema, oedema/papulation, oozing/crusts, excoriations, and lichenification
Time frame: 37 days
4 secondary outcomes
Skin Erythema measurement
Time frame: 37 days
Transepidermal Water Loss (TEWL) measurement
Time frame: 37 days
Visual Analogue Scale (VAS) assessment for itching (pruritus) of the treatment area
Time frame: 37 days
Physician Global Assessment (PGA)
Time frame: 37 days
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 21 Jun 2012.
- Background: PubMed 18385500Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. doi: 10.1056/NEJMra074081. No abstract available.
- Background: PubMed 19494826Cork MJ, Danby SG, Vasilopoulos Y, Hadgraft J, Lane ME, Moustafa M, Guy RH, Macgowan AL, Tazi-Ahnini R, Ward SJ. Epidermal barrier dysfunction in atopic dermatitis. J Invest Dermatol. 2009 Aug;129(8):1892-908. doi: 10.1038/jid.2009.133. Epub 2009 Jun 4.
- Background: PubMed 6223114De Fabo EC, Noonan FP. Mechanism of immune suppression by ultraviolet irradiation in vivo. I. Evidence for the existence of a unique photoreceptor in skin and its role in photoimmunology. J Exp Med. 1983 Jul 1;158(1):84-98. doi: 10.1084/jem.158.1.84.
- Background: PubMed 8435513Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. doi: 10.1159/000247298.
- Background: PubMed 17498413Hanifin JM, Reed ML; Eczema Prevalence and Impact Working Group. A population-based survey of eczema prevalence in the United States. Dermatitis. 2007 Jun;18(2):82-91. doi: 10.2310/6620.2007.06034.
- Background: PubMed 2800895Rajka G, Langeland T. Grading of the severity of atopic dermatitis. Acta Derm Venereol Suppl (Stockh). 1989;144:13-4. doi: 10.2340/000155551441314.
- Background: PubMed 10494710Wolkerstorfer A, de Waard van der Spek FB, Glazenburg EJ, Mulder PG, Oranje AP. Scoring the severity of atopic dermatitis: three item severity score as a rough system for daily practice and as a pre-screening tool for studies. Acta Derm Venereol. 1999 Sep;79(5):356-9. doi: 10.1080/000155599750010256.
- Derived from this study: PubMed 24284985Peltonen JM, Pylkkanen L, Jansen CT, Volanen I, Lehtinen T, Laihia JK, Leino L. Three randomised phase I/IIa trials of 5% cis-urocanic acid emulsion cream in healthy adult subjects and in patients with atopic dermatitis. Acta Derm Venereol. 2014 Jul;94(4):415-20. doi: 10.2340/00015555-1735.
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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.
Sakari Reitamo, Professor principal investigator
Helsinki University Central Hospital, Skin and Allergy Hospital
7 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 Cis-UCA 2.5% emulsion cream, Cis-UCA 5% emulsion cream and Protopic® 0.1% ointment in people with Atopic Dermatitis, run by BioCis Pharma Ltd at 7 sites in Finland.
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 7 inclusion and 15 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 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Finland. 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 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?
Clinical Skin Assessment of erythema, oedema/papulation, oozing/crusts, excoriations, and lichenification (time frame: 37 days). 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 NCT01320579, which also lists 8 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 21 Jun 2012.