Severe Seborrheic DermatitisPhase 3DiseaseNCT02004860
Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis
A Phase 3 study testing Protopic (R) and Mycoster (R) in people with Severe Seborrheic Dermatitis, run by University Hospital, Rouen at 1 site in France.
Trial summary
Seborrheic dermatitis is a chronic inflammatory dermatological disease, evolving by relapses, affecting mainly the face and scalp. It would be important to have a maintenance treatment for severe forms of seborrheic dermatitis witch is both effective and relatively well tolerated to reduce the frequency of relapses… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Seborrheic Dermatitis
- What is being tested?
- Protopic (R) and Mycoster (R)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Oct 2017
- Phase
- Phase 3
- 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
- in Phase 1: Attack Treatment (open)
- over the age of eighteen patient,
- Seborrheic dermatitis Severe,
- participation with an informed consent,
- Women of childbearing age in effective contraception for the duration of the study or postmenopausal women.
- in Phase 2: Phase 2: "Randomization" (blind)
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- Patient achieved a complete or almost complete clinical remission after the initial treatment,
- known immunodeficiency (HIV patient receiving chemotherapy) or immunosuppressive therapy or biotherapy,
- patient taking regular systemic corticosteroids at a dose> 20 mg / day
- erythematous lesions with topography other than the face and evocative scalp psoriasis (elbows, knees ...), by referring to the possibility that the facial lesions correspond to lesions sebopsoriasis,
- woman pregnant, nursing or in childbearing potential without effective contraception,
- man wishing to have a child during the study period,
- Ultra Violet (UV) phototherapy or usual realization of UV sessions aesthetic purposes,
- Seborrheic dermatitis symptomatic of an underlying disease known or revealing
- history of cancer or lymphoma,
- progressive cancer or lymphoma,
- Seborrheic dermatitis exclusively affecting the scalp,
- known allergy to one-component products study ,
- malnourished patient or sick history of chronic pancreatitis by a suspect to deficiency dermatitis,
- participation in a clinical trial on the Seborrheic dermatitis in the previous 90 days,
- patient with lesions considered potentially malignant or pre-cancerous,
- patient with abnormal skin barrier.
Who cannot join
- in Phase 1: Attack Treatment (open)
- 1) Patient had already been treated with Protopic ® for Seborrheic Dermatitis,
- Phase 2: "Randomization" (blind) 1) Patient with no complete or almost complete clinical remission after the initial treatment,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 : Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis on Adult Face
Seborrheic dermatitis is a chronic inflammatory dermatological disease, evolving by relapses, affecting mainly the face and scalp. It would be important to have a maintenance treatment for severe forms of seborrheic dermatitis witch is both effective and relatively well tolerated to reduce the frequency of relapses, prolong remissions obtained after attack treatment and reduce the use of topical steroids.
- Conditions
- Severe Seborrheic Dermatitis
- Being tested
- Protopic (R), Mycoster (R)
- Keywords
- local immunosuppressive, Maintenance therapy
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protopic (R)Drug
Also called Tacrolimus
Protopic® 0.1% ointment - 2 applications per week for 6 months
Mycoster (R)Drug
Also called Ciclopirox olamine
Mycoster 1% - 2 applications per week for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Protopic Arm | Experimental | Protopic® 0.1% ointment - 2 applications per week for 6 months Receives: Drug: Protopic (R) |
| Mycoster Arm | Active comparator | 2 applications per week for 6 months Receives: Drug: Mycoster (R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of the maintenance of complete or almost complete clinical remission
The primary endpoint will be the duration of the maintenance of complete or almost complete clinical remission obtained after the initial treatment. This period is defined as the time from randomization to the first occurrence of relapse noted by the dermatologist.
Measured: 18 months after inclusion (Visit (V) 4 last visit)
Secondary outcomes (4)
Tolerance of 2 treatments
Tolerance of 2 treatments Mycoster (R) and Protocopic (R)
Measured: between 10 days and 18 months after inclusion (V3 (Day (D)10 to D180)), 30 days after inclusion (Visit D30), after 90 days after inclusion (D90) and after 120 days after inclusion (D120) and 180 days after inclusion (Visit V4)
Number of Relapses
Number of Relapses requiring the resumption of topical corticosteroid treatment,
Measured: 180 days after inclusion (Visit V4)
Cumulative amount of corticosteroids applied
Cumulative amount of corticosteroids applied by the patients during the study period to control their outbreaks
Measured: between 10 days and 18 months after inclusion (V3 (D10 to D180)), 30 days after inclusion (Visit D30), after 90 days after inclusion (D90) and after 120 days after inclusion (D120) and 180 days after inclusion (Visit V4)
quality of life of patients
quality of life of patients
Measured: Inclusion (visit D0) and Last visit 180 days after inclusion (Visit D180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Seborrheic DermatitisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal JOLY, Professor, Study director, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004860
- Sponsor's protocol ID
- 2011/104/HP
- Other IDs
- 2011-004186-32
- Acronym
- Disease
- Status last verified
- May 2018
- First submitted
- 26 Aug 2013
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 : Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis on Adult Face
- ClinicalTrials.gov ID
- NCT02004860
- Acronym / sponsor ID
- Disease / 2011/104/HP
- Conditions
- Severe Seborrheic Dermatitis
- Keywords
- local immunosuppressive, Maintenance therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 9 Dec 2013 (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.
Seborrheic dermatitis is a chronic inflammatory dermatological disease, evolving by relapses, affecting mainly the face and scalp. It would be important to have a maintenance treatment for severe forms of seborrheic dermatitis witch is both effective and relatively well tolerated to reduce the frequency of relapses, prolong remissions obtained after attack treatment and reduce the use of topical steroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protopic Arm | Experimental | Drug: Protopic (R)Protopic® 0.1% ointment - 2 applications per week for 6 months |
| Mycoster Arm | Active comparator | Drug: Mycoster (R)2 applications per week for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- in Phase 1: Attack Treatment (open)
- in Phase 2: Phase 2: "Randomization" (blind)
Key exclusion criteria (3 listed)
- in Phase 1: Attack Treatment (open)
- 1) Patient had already been treated with Protopic ® for Seborrheic Dermatitis,
- Phase 2: "Randomization" (blind) 1) Patient with no complete or almost complete clinical remission after the initial treatment,
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 |
|---|---|---|
| Protopic (R)Also: TacrolimusProtopic® 0.1% ointment - 2 applications per week for 6 months | Drug | Protopic Arm |
| Mycoster (R)Also: Ciclopirox olamineMycoster 1% - 2 applications per week for 6 months | Drug | Mycoster Arm |
Primary outcome
duration of the maintenance of complete or almost complete clinical remission
Time frame: 18 months after inclusion (Visit (V) 4 last visit)
The primary endpoint will be the duration of the maintenance of complete or almost complete clinical remission obtained after the initial treatment. This period is defined as the time from randomization to the first occurrence of relapse noted by the dermatologist.
4 secondary outcomes
Tolerance of 2 treatments
Time frame: between 10 days and 18 months after inclusion (V3 (Day (D)10 to D180)), 30 days after inclusion (Visit D30), after 90 days after inclusion (D90) and after 120 days after inclusion (D120) and 180 days after inclusion (Visit V4)
Number of Relapses
Time frame: 180 days after inclusion (Visit V4)
Cumulative amount of corticosteroids applied
Time frame: between 10 days and 18 months after inclusion (V3 (D10 to D180)), 30 days after inclusion (Visit D30), after 90 days after inclusion (D90) and after 120 days after inclusion (D120) and 180 days after inclusion (Visit V4)
quality of life of patients
Time frame: Inclusion (visit D0) and Last visit 180 days after inclusion (Visit D180)
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 29 May 2018.
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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.
Pascal JOLY, Professor study director
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Protopic (R) and Mycoster (R) in people with Severe Seborrheic Dermatitis, run by University Hospital, Rouen at 1 site in France.
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 22 inclusion and 3 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 29 May 2018. 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 France. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
duration of the maintenance of complete or almost complete clinical remission (time frame: 18 months after inclusion (Visit (V) 4 last visit)). 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 29 May 2018.