Atopic DermatitisPhase 2CYCLATOPNCT02865356
Topical Solution for the Treatment of Atopic Dermatitis
A Phase 2 study testing Cyclosporine 5% solution in people with Atopic Dermatitis, run by Spherium Biomed at 9 sites in Spain.
Trial summary
The study is designed as a proof of concept, multi-center, randomized, double-blind and vehicle-controlled study with intra-individual comparison of treatments. Three age cohorts of patients will be included in the study according to the following age ranges: 1. ≥18 years old (minimum 6, maximum 18 patients) 2. Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Cyclosporine 5% solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 9 sitesSpain
- Study dates
- Sep 2016to 12 Apr 2017
- 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 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female aged between 2 and 75 years, inclusive, at the screening visit. 2. AD diagnosis according to the Hanifin/Rajka criteria with one eczema outbreak at the screening and baseline.
- 3. Presence of at least two lesional areas. These areas should be at the left and right side of the body and occupying a body surface area (BSA) in each side between 0.1% and 10% of the BSA. IGA score of the two sites not differ by more than 1 point.
- 4. Mild to moderate disease severity of AD defined by an IGA score of 2 or 3 at baseline (IGA scale from 0 to 4).
- 5. Total BSA of AD involvement ≤ 10% in each side of the body (≤ 20% maximum). 6. 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 (both included).
- 7. General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial.
- 8. Parent's or legal guardian's written informed consent and child assent, if appropriate or patient's inform consent for patients ≥ 18 years of age before any assessment is performed.
- 9. Able to communicate with the investigator and comply with the requirements of the study (for children the parent can assist when necessary).
Who cannot join
- 1. 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 SP14019-F-01 topical solution 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). Women with tubal ligation are required to use 1 non-hormonal contraceptive method.
Show all 20Show fewer
- Women who are postmenopausal for at least 2 years, and women with total hysterectomy are considered of non-childbearing potential. Males with partners of childbearing potential should inform them of their participation in this clinical study and use a highly effective method of birth control during the study.
- 2. Pregnant woman or with a positive pregnancy test or breast feeding at baseline.
- 3. Any condition in the lesions that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash other than AD, sunburn, scars, hairy or tattooed area.
- 4. Patients receiving phototherapy or systemic therapy for AD within 4 weeks before the first application of trial medication.
- 5. Patients receiving antibiotics, topical therapy for AD within 2 weeks before the first application of trial medication.
- 6. Patients taking antihistamines within 1 week before the first application of trial medication.
- 7. Patients receiving radiation therapy, systemic therapy with cytostatics or biological therapy within 24 weeks before the first application of trial medication, or with previous history of malignancy (excluding basal cell carcinoma).
- 8. Patients with any acute skin infection (superinfection or secondary impetiginisation).
- 9. Patients with confirmed hypertension, renal disease or serious infections at screening.
- 10. Any currently active allergy such as but not limited to drug allergy, food allergy or hay fever.
- 11. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the trial medication administered in this trial.
- 12. Participation in an investigational drug trial within 30 days prior to the first application of trial medication.
- 13. 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.
- 14. Subjects who have received or are planning to receive any vaccination within 28 days prior to the first dose of study medication, or planning to receive a vaccination during the course of the study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, 08003
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 08950
Hospital Universitario de La Princesa
Madrid, 28006
Hospital Infantil Universitario Niño Jesús
Madrid
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitari i Politècnic La Fe
Valencia, 46026
About this study
Official title: Evaluation of SP14019-F-01 Topical Solution for the Treatment of Atopic Dermatitis. Pilot Study (CYCLATOP STUDY)
The study is designed as a proof of concept, multi-center, randomized, double-blind and vehicle-controlled study with intra-individual comparison of treatments.
Three age cohorts of patients will be included in the study according to the following age ranges:
Read more
- ≥18 years old (minimum 6, maximum 18 patients)
- >12 - 17 years old (minimum 6, maximum 18 patients)
- >2 - 12 years old (minimum 6, maximum 18 patients)
The main objectives of study are:
To assess the efficacy of SP14019-F-01 topical solution (5% cyclosporine A [CsA]) compared to placebo topical solution for the treatment of patients with mild to moderate atopic dermatitis (AD).
To evaluate the safety and tolerability of SP14019-F-01 (5% CsA) topical solution in patients with mild to moderate AD.
Read the detailed description
The study is designed as a proof of concept, multi-center, randomized, double-blind and vehicle-controlled study with intra-individual comparison of treatments. CsA plasma concentration assessments will be carried out at Visit 0 predose, and Visits 1 and 4 of the study period.
Three age cohorts of patients will be included in the study according to the following age ranges:
- ≥18 years old (minimum 6, maximum 18 patients)
- >12 - 17 years old (minimum 6, maximum 18 patients)
- >2 - 12 years old (minimum 6, maximum 18 patients) The study will close when the total of 36 patients has been included among all age groups and the minimum number of 6 patients has been reached for each age group.
Before including paediatric population, a minimum of 6 adult patients should complete the treatment to assess the safety profile.
A randomized list will be created to determine in which side of the body (left or right) the subject will apply each medication (SP14019-F-01 topical solution [5% CsA] or SP14019-F-02 vehicle-control placebo solution). Solutions will be applied twice daily for four complete weeks (28 days) in all affected areas.
Photography will be used to record the evolution of the lesions at Visits 0 (pre-1st dose), Visits 1, 2, 3, 4 and follow-up.
The main objectives of study are:
To assess the efficacy of SP14019-F-01 topical solution (5% cyclosporine A [CsA]) compared to placebo topical solution for the treatment of patients with mild to moderate atopic dermatitis (AD).
To evaluate the safety and tolerability of SP14019-F-01 (5% CsA) topical solution in patients with mild to moderate AD.
A Steering Committee will convene periodically to maintain the quality of study conduct, and to discuss any major issues or concerns and with particular attention to some critical events which may lead to stop the recruitment. These critical events are the observation of either new unexpected signals on safety related to CsA. The Steering Committee will also evaluate the safety profile of the treatment before including paediatric population
- Conditions
- Atopic Dermatitis
- Being tested
- Cyclosporine 5% solution, Placebo
- Keywords
- atopic dermatitis, eczema, children, skin, topical, cyclosporine
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine 5% solutionDrug
Also called ciclosporin
topical solution
PlaceboDrug
Also called SP14019-F-02 Placebo
topical vehicle solution
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine 5% Solution | Experimental | SP14019-F-01 Cyclosporine solution, 5%. Cyclosporine solution will be applied twice daily for four complete weeks (28 days) in all affected areas.
A randomized list will be created to determine in which side of the body (left or right) the subject will apply each medication Receives: Drug: Cyclosporine 5% solution |
| Placebo | Placebo comparator | SP14019-F-02 vehicle-control placebo solution. Vehicle-control placebo solution will be applied twice daily for four complete weeks (28 days) in all affected areas.
A randomized list will be created to determine in which side of the body (left or right) the subject will apply each medication Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline (Day 0) of Eczema Area and Severity Index (EASI) score of the treated body area (CsA vs Vehicle control placebo)
Measured: Absolute change from Day 0 (baseline) to Day 7 (Visit 1), Day 14 (Visit 2), Day 21(Visit 3) and Day 28 (Visit 4).
Change from baseline (Day 0) of Investigator's Global Assessment (IGA) score (on a 0 to 4-point scale; CsA vs Vehicle control placebo)
Measured: Absolute change from Day 0 (baseline) to Day 7 (Visit 1), Day 14 (Visit 2), Day 21(Visit 3) and Day 28 (Visit 4).
Absolute change from baseline (Day 0) of Atopic Dermatitis Severity Index (ADSI) score (Cs vs Vehicle control placebo)
Measured: Absolute change from Day 0 (baseline) to Day 7 (Visit 1), Day 14 (Visit 2), Day 21(Visit 3) and Day 28 (Visit 4).
Secondary outcomes (3)
Frequency and severity of treatment-emergent adverse events (TEAEs).
Measured: From date of randomization (Day 0) until 6 weeks
Frequency and severity of TEAEs leading to study drug discontinuation
Measured: From date of randomization (Day 0) until 6 weeks
CsA plasma concentrations
samples obtained just before the first daily dose (around 8 am) on Visits 0, 1 and 4 to check the absence of systemic absorption during the period of treatment.
Measured: From date of randomization (Day 0) up to 4 weeks, on day 7 and 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion12 Apr 2017
- Study completion12 Apr 2017
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spherium Biomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Germans Trias i Pujol Hospital, Hospital del Mar, Hospital Sant Joan de Deu, Hospital Universitario Virgen Macarena, Hospital Universitario La Fe, Hospital General Universitario de Alicante, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital Universitario Virgen de la Victoria, Hospital Infantil Universitario Niño Jesús, Madrid, Spain
- Responsible party
- Sponsor
- Investigators
- Carlos Ferrándiz, MD, PhD, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865356
- Sponsor's protocol ID
- SP14019-18
- Acronym
- CYCLATOP
- Status last verified
- Apr 2018
- First submitted
- 4 Aug 2016
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SP14019-F-01 Topical Solution for the Treatment of Atopic Dermatitis. Pilot Study (CYCLATOP STUDY)
- ClinicalTrials.gov ID
- NCT02865356
- Acronym / sponsor ID
- CYCLATOP / SP14019-18
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, eczema, children, skin, topical, cyclosporine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Spherium BiomedIndustry (pharma, biotech, devices)
- Collaborators
- Germans Trias i Pujol Hospital, Hospital del Mar, Hospital Sant Joan de Deu, Hospital Universitario Virgen Macarena, Hospital Universitario La Fe, Hospital General Universitario de Alicante, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital Universitario Virgen de la Victoria, Hospital Infantil Universitario Niño Jesús, Madrid, Spain
- Study start
- Sep 2016
- Primary completion
- 12 Apr 2017 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 12 Aug 2016 (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 study is designed as a proof of concept, multi-center, randomized, double-blind and vehicle-controlled study with intra-individual comparison of treatments.
Three age cohorts of patients will be included in the study according to the following age ranges:
- ≥18 years old (minimum 6, maximum 18 patients)
- >12 - 17 years old (minimum 6, maximum 18 patients)
- >2 - 12 years old (minimum 6, maximum 18 patients)
The main objectives of study are:
To assess the efficacy of SP14019-F-01 topical solution (5% cyclosporine A [CsA]) compared to placebo topical solution for the treatment of patients with mild to moderate atopic dermatitis (AD).
To evaluate the safety and tolerability of SP14019-F-01 (5% CsA) topical solution in patients with mild to moderate AD.
Detailed description
The study is designed as a proof of concept, multi-center, randomized, double-blind and vehicle-controlled study with intra-individual comparison of treatments. CsA plasma concentration assessments will be carried out at Visit 0 predose, and Visits 1 and 4 of the study period.
Three age cohorts of patients will be included in the study according to the following age ranges:
- ≥18 years old (minimum 6, maximum 18 patients)
- >12 - 17 years old (minimum 6, maximum 18 patients)
- >2 - 12 years old (minimum 6, maximum 18 patients) The study will close when the total of 36 patients has been included among all age groups and the minimum number of 6 patients has been reached for each age group.
Before including paediatric population, a minimum of 6 adult patients should complete the treatment to assess the safety profile.
A randomized list will be created to determine in which side of the body (left or right) the subject will apply each medication (SP14019-F-01 topical solution [5% CsA] or SP14019-F-02 vehicle-control placebo solution). Solutions will be applied twice daily for four complete weeks (28 days) in all affected areas.
Photography will be used to record the evolution of the lesions at Visits 0 (pre-1st dose), Visits 1, 2, 3, 4 and follow-up.
The main objectives of study are:
To assess the efficacy of SP14019-F-01 topical solution (5% cyclosporine A [CsA]) compared to placebo topical solution for the treatment of patients with mild to moderate atopic dermatitis (AD).
To evaluate the safety and tolerability of SP14019-F-01 (5% CsA) topical solution in patients with mild to moderate AD.
A Steering Committee will convene periodically to maintain the quality of study conduct, and to discuss any major issues or concerns and with particular attention to some critical events which may lead to stop the recruitment. These critical events are the observation of either new unexpected signals on safety related to CsA. The Steering Committee will also evaluate the safety profile of the treatment before including paediatric population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine 5% Solution | Experimental | Drug: Cyclosporine 5% solutionSP14019-F-01 Cyclosporine solution, 5%. Cyclosporine solution will be applied twice daily for four complete weeks (28 days) in all affected areas. A randomized list will be created to determine in which side of the body (left or right) the subject will apply each medication |
| Placebo | Placebo comparator | Drug: PlaceboSP14019-F-02 vehicle-control placebo solution. Vehicle-control placebo solution will be applied twice daily for four complete weeks (28 days) in all affected areas. A randomized list will be created to determine in which side of the body (left or right) the subject will apply each medication |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged between 2 and 75 years, inclusive, at the screening visit. 2. AD diagnosis according to the Hanifin/Rajka criteria with one eczema outbreak at the screening and baseline.
- 3. Presence of at least two lesional areas. These areas should be at the left and right side of the body and occupying a body surface area (BSA) in each side between 0.1% and 10% of the BSA. IGA score of the two sites not differ by more than 1 point.
- 4. Mild to moderate disease severity of AD defined by an IGA score of 2 or 3 at baseline (IGA scale from 0 to 4).
- 5. Total BSA of AD involvement ≤ 10% in each side of the body (≤ 20% maximum). 6. 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 (both included).
- 7. General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial.
Key exclusion criteria (20 listed)
- 1. 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 SP14019-F-01 topical solution 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);
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 |
|---|---|---|
| Cyclosporine 5% solutionAlso: ciclosporintopical solution | Drug | Cyclosporine 5% Solution |
| PlaceboAlso: SP14019-F-02 Placebotopical vehicle solution | Drug | Placebo |
Primary outcome
Absolute change from baseline (Day 0) of Eczema Area and Severity Index (EASI) score of the treated body area (CsA vs Vehicle control placebo)
Time frame: Absolute change from Day 0 (baseline) to Day 7 (Visit 1), Day 14 (Visit 2), Day 21(Visit 3) and Day 28 (Visit 4).
Change from baseline (Day 0) of Investigator's Global Assessment (IGA) score (on a 0 to 4-point scale; CsA vs Vehicle control placebo)
Time frame: Absolute change from Day 0 (baseline) to Day 7 (Visit 1), Day 14 (Visit 2), Day 21(Visit 3) and Day 28 (Visit 4).
Absolute change from baseline (Day 0) of Atopic Dermatitis Severity Index (ADSI) score (Cs vs Vehicle control placebo)
Time frame: Absolute change from Day 0 (baseline) to Day 7 (Visit 1), Day 14 (Visit 2), Day 21(Visit 3) and Day 28 (Visit 4).
3 secondary outcomes
Frequency and severity of treatment-emergent adverse events (TEAEs).
Time frame: From date of randomization (Day 0) until 6 weeks
Frequency and severity of TEAEs leading to study drug discontinuation
Time frame: From date of randomization (Day 0) until 6 weeks
CsA plasma concentrations
Time frame: From date of randomization (Day 0) up to 4 weeks, on day 7 and 28.
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 17 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Carlos Ferrándiz, MD, PhD principal investigator
Germans Trias i Pujol Hospital
9 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 Cyclosporine 5% solution in people with Atopic Dermatitis, run by Spherium Biomed at 9 sites 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 7 inclusion and 20 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 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 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?
Absolute change from baseline (Day 0) of Eczema Area and Severity Index (EASI) score of the treated body area (CsA vs Vehicle control placebo) (time frame: Absolute change from Day 0 (baseline) to Day 7 (Visit 1), Day 14 (Visit 2), Day 21(Visit 3) and Day 28 (Visit 4).). The study lists 3 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 17 Apr 2018.