Dermatitis, AtopicPhase 4NCT01828879
An Efficacy and Safety Study of Tacrolimus Ointment in Adult Participants With Atopic Dermatitis
A Phase 4 study testing Tacrolimus in people with Dermatitis, Atopic, run by Janssen-Cilag Ltd.,Thailand at 2 sites in Vietnam.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of tacrolimus ointment in treating the signs and symptoms of moderate (medium level of seriousness) to severe (very serious, life threatening) atopic dermatitis (an intensely pruritic [itching], chronic [lasting a long time], inflammatory [pain and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesVietnam
- Study dates
- Nov 2007to Dec 2009
- Phase
- Phase 4
- 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
- Participants with a diagnosis of atopic dermatitis using Hanifin and Rajka Criteria (major criteria: pruritus, lichenification [crusting over], chronic relapsing [the return of a medical problem] course, family history of atopy and minor criteria: xerosis [dry skin], ichthyosis [skin disorders characterized by dryness, roughness, and scaliness], immediate Type I reactions [reactions which occur within minutes of exposure to challenging antigen: substances that are recognized by the immune system and induce an immune reaction] to skin test antigens) involving at least 10 percent of the body surface area
- Participants not having other skin disorders and severe heart, liver, kidney and lung diseases
- Participants who have given informed consent
- Female participants with child-bearing potential must have a negative pregnancy test
- Participant meets the following washout requirements (washout period ranging from 1-42 days) before study: 1 day (for non-medicated topical [applied to skin; surface] agents); 7 days (for terfenadine, other non-sedating systemic antihistamines [drug used to treat allergic reaction], topical corticosteroids (steroid hormone), H1 and H2 antihistamines, antimicrobial [drug that kills bacteria and other germs], other medicated topical agents); 14 days (for intranasal [delivery of medications through the nasal mucosa] and/or inhaled corticosteroids); 28 days (for light treatments [ultra violet rays A, ultra violet rays B], non-steroidal immunosuppressants [drug which suppresses the body's immune response, used in transplantation and diseases caused by disordered immunity], other investigational drugs and systemic corticosteroids); and 42 days (for astemizole)
Who cannot join
- Participant with a skin disorder other than atopic dermatitis in the areas to be treated
- Participant who have pigmentation or extensive scarring or pigmented lesions (abnormal area of tissue, such as a wound, sore, rash, or boil) in the areas to be treated which would interfere with rating of efficacy parameters
- Participant who have clinically infected atopic dermatitis at baseline
- Participant with a systemic disease, including cancer (abnormal tissue that grows and spreads in the body until it kills) or a history of cancer or Human Immunodeficiency Virus (HIV: a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person), which would contraindicate (medical reasons that prevent a person from using a certain drug or treatment) the use of immunosuppressants
- Participant with a known hypersensitivity (altered reactivity to an antigen) to macrolides (drugs exhibiting antibiotic properties) or any excipient of the ointment
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: The Efficacy and Safety of Tacrolimus Ointment in Adult Patients With Moderate to Severe Atopic Dermatitis
The purpose of this study is to evaluate the safety and efficacy of tacrolimus ointment in treating the signs and symptoms of moderate (medium level of seriousness) to severe (very serious, life threatening) atopic dermatitis (an intensely pruritic [itching], chronic [lasting a long time], inflammatory [pain and swelling], immunologically based skin disease with a genetic predisposition [latent susceptibility to disease at the genetic level]) in adult participants.
Read the detailed description
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), randomized (like the flip of a coin), multi-center study in adult participants with moderate to severe atopic dermatitis. Participants will be treated with 0.1 percent concentration of tacrolimus ointment which will be applied twice daily for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first. The study will consist of 6 visits: pre-study (optional), Baseline or Day 1, Weeks 1, 2, 3 and 4 (end-of-treatment). The ointment should be applied at least 2 hours before or at least 30 minutes after bathing, showering, shaving, use of sauna, or heavy exercise (i.e. causes sweating). On study visit days, the ointment should be applied at least 2 hours before the visit. Efficacy evaluation will be done at all subsequent study visits in participants receiving study drug for at least 3 consecutive days (minimum of 5 applications) while the participants who will receive at least 1 application of the study drug, will be evaluated for safety. Primary efficacy evaluation will be based on the Physician's Global Evaluation of Clinical Response (PhGECR). Participants' safety will be monitored throughout the study.
- Conditions
- Dermatitis, Atopic
- Being tested
- Tacrolimus
- Keywords
- Dermatitis, Atopic, Tacrolimus
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Tacrolimus ointment, 0.1 percent will be applied twice daily, in adult population for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first.
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus ointment | Experimental | Tacrolimus ointment, 0.1 percent will be applied twice daily, in adult population for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first. Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's Global Evaluation of Clinical Response (PhGECR)
PhGECR scale evaluates the change in the lesions of atopic dermatitis, which is defined as the lesions identified by Investigator for treatment at Baseline only, using scores ranging from, less than 0 to 100: wherein, less than 0=worse, 0-29=no appreciable improvement, 30-49=slight improvement, 50-74=moderate improvement, 75-89=marked improvement, 90-99=excellent improvement and 100=cleared.
Measured: Week 4
Secondary outcomes (3)
Eczema Area and Severity Index (EASI)
A composite index of area involved and severity of the signs of atopic dermatitis in the 4 regions (head and neck, upper limbs, trunk, lower limbs) will be calculated using the physician's assessment of individual signs using a scale ranging from 0 to 3: 0=absent, 1=mild, 2=moderate, 3=severe; and the affected area assessment (the percentage of body surface area affected by atopic dermatitis) of the lesions defined in the baseline treatment area will be estimated by the physician on the basis of area score ranging from 0 to 6: 0=0 percent and 6=90 to 100 percent.
Measured: Week 1, 2, 3 and 4
Participant's Assessment of Treatment Effects
Participants will make 2 assessments at each study visit (before and after treatment) based on all affected areas (ratio of 100 percent). The assessment rates include: much better, better, slightly better, same, slightly worse, worse. Much better and better is considered good.
Measured: Week 1, 2, 3 and 4
Participant's Assessment of Itch
Participant's itch will be assessed using a Visual Analog Scale ranging from 0 to 100: 0-19=no or slight itch; 20-39=mild itch; 40-59=moderate itch; 60-79=severe itch; 80-100=worst itch.
Measured: Week 1, 2, 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startNov 2007
- Primary completionJun 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.,Thailand
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd.,Thailand Clinical Trial, Study director, Janssen-Cilag Ltd.,Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828879
- Sponsor's protocol ID
- CR017833
- Other IDs
- R098924ADM4006
- Status last verified
- Apr 2013
- First submitted
- 21 Mar 2013
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Tacrolimus Ointment in Adult Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01828879
- Acronym / sponsor ID
- CR017833
- Conditions
- Dermatitis, Atopic
- Keywords
- Dermatitis, Atopic, Tacrolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.,ThailandIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Apr 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.
The purpose of this study is to evaluate the safety and efficacy of tacrolimus ointment in treating the signs and symptoms of moderate (medium level of seriousness) to severe (very serious, life threatening) atopic dermatitis (an intensely pruritic [itching], chronic [lasting a long time], inflammatory [pain and swelling], immunologically based skin disease with a genetic predisposition [latent susceptibility to disease at the genetic level]) in adult participants.
Detailed description
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), randomized (like the flip of a coin), multi-center study in adult participants with moderate to severe atopic dermatitis. Participants will be treated with 0.1 percent concentration of tacrolimus ointment which will be applied twice daily for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first. The study will consist of 6 visits: pre-study (optional), Baseline or Day 1, Weeks 1, 2, 3 and 4 (end-of-treatment). The ointment should be applied at least 2 hours before or at least 30 minutes after bathing, showering, shaving, use of sauna, or heavy exercise (i.e. causes sweating). On study visit days, the ointment should be applied at least 2 hours before the visit. Efficacy evaluation will be done at all subsequent study visits in participants receiving study drug for at least 3 consecutive days (minimum of 5 applications) while the participants who will receive at least 1 application of the study drug, will be evaluated for safety. Primary efficacy evaluation will be based on the Physician's Global Evaluation of Clinical Response (PhGECR). Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus ointment | Experimental | Drug: TacrolimusTacrolimus ointment, 0.1 percent will be applied twice daily, in adult population for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants with a diagnosis of atopic dermatitis using Hanifin and Rajka Criteria (major criteria: pruritus, lichenification [crusting over], chronic relapsing [the return of a medical problem] course, family history of atopy and minor criteria: xerosis [dry skin], ichthyosis [skin disorders characterized by dryness, roughness, and scaliness], immediate Type I reactions [reactions which occur within minutes of exposure to challenging antigen: substances that are recognized by the immune system and induce an immune reaction] to skin test antigens) involving at least 10 percent of the body surface area
- Participants not having other skin disorders and severe heart, liver, kidney and lung diseases
- Participants who have given informed consent
- Female participants with child-bearing potential must have a negative pregnancy test
- Participant meets the following washout requirements (washout period ranging from 1-42 days) before study: 1 day (for non-medicated topical [applied to skin; surface] agents); 7 days (for terfenadine, other non-sedating systemic antihistamines [drug used to treat allergic reaction], topical corticosteroids (steroid hormone), H1 and H2 antihistamines, antimicrobial [drug that kills bacteria and other germs], other medicated topical agents); 14 days (for intranasal [delivery of medications through the nasal mucosa] and/or inhaled corticosteroids); 28 days (for light treatments [ultra violet rays A, ultra violet rays B], non-steroidal immunosuppressants [drug which suppresses the body's immune response, used in transplantation and diseases caused by disordered immunity], other investigational drugs and systemic corticosteroids); and 42 days (for astemizole)
Key exclusion criteria (5 listed)
- Participant with a skin disorder other than atopic dermatitis in the areas to be treated
- Participant who have pigmentation or extensive scarring or pigmented lesions (abnormal area of tissue, such as a wound, sore, rash, or boil) in the areas to be treated which would interfere with rating of efficacy parameters
- Participant who have clinically infected atopic dermatitis at baseline
- Participant with a systemic disease, including cancer (abnormal tissue that grows and spreads in the body until it kills) or a history of cancer or Human Immunodeficiency Virus (HIV: a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person), which would contraindicate (medical reasons that prevent a person from using a certain drug or treatment) the use of immunosuppressants
- Participant with a known hypersensitivity (altered reactivity to an antigen) to macrolides (drugs exhibiting antibiotic properties) or any excipient of the ointment
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 |
|---|---|---|
| TacrolimusTacrolimus ointment, 0.1 percent will be applied twice daily, in adult population for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first. | Drug | Tacrolimus ointment |
Primary outcome
Physician's Global Evaluation of Clinical Response (PhGECR)
Time frame: Week 4
PhGECR scale evaluates the change in the lesions of atopic dermatitis, which is defined as the lesions identified by Investigator for treatment at Baseline only, using scores ranging from, less than 0 to 100: wherein, less than 0=worse, 0-29=no appreciable improvement, 30-49=slight improvement, 50-74=moderate improvement, 75-89=marked improvement, 90-99=excellent improvement and 100=cleared.
3 secondary outcomes
Eczema Area and Severity Index (EASI)
Time frame: Week 1, 2, 3 and 4
Participant's Assessment of Treatment Effects
Time frame: Week 1, 2, 3 and 4
Participant's Assessment of Itch
Time frame: Week 1, 2, 3 and 4
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 11 Apr 2013.
- The efficacy and safety of tacrolimus ointment in Adult patients with moderate to severe atopic dermatitisLink provided by the sponsor.
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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.
Janssen-Cilag Ltd.,Thailand Clinical Trial study director
Janssen-Cilag Ltd.,Thailand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus in people with Dermatitis, Atopic, run by Janssen-Cilag Ltd.,Thailand at 2 sites in Vietnam.
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 5 inclusion and 5 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 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Physician's Global Evaluation of Clinical Response (PhGECR) (time frame: Week 4). 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 11 Apr 2013.