Atopic DermatitisPhase 1NCT00833079
Bioequivalence of Two Tacrolimus 0.1% Topical Ointment Formulations in Patients With Atopic Dermatitis
A Phase 1 study testing Tacrolimus 0.1% manufactured by Taro and Protopic - Tacrolimus 0.1% in people with Atopic Dermatitis, run by Sun Pharmaceutical Industries, Inc..
Trial summary
The primary objectives are to establish the therapeutic equivalence of tacrolimus ointment 0.1%, manufactured by Taro Pharmaceuticals Inc. and Protopic® (tacrolimus), 0.1% topical ointment (Astellas Pharma US, Inc.) and to show superiority over vehicle in the treatment of moderate to severe 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?
- Tacrolimus 0.1% manufactured by Taro and Protopic - Tacrolimus 0.1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Mar 2010
- Phase
- Phase 1
- 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
- Male or non-pregnant, non-lactating female, 18 years of age or older.
- Patient has documented evidence that they have been unresponsive to alternative more traditional therapies such as topical corticosteroids, or in the investigators opinion, such first line therapy would be deemed inadvisable because of potential risks to the patient.
- If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, IUD, oral, transdermal, injected or implanted hormonal contraceptives).
- Have confirmed diagnosis of atopic dermatitis using the diagnostic features as described by Hanifin and Rajka.
- Have an IGSA score of 3 (moderate) or 4 (severe)
- Have an affected Body Surface Area (BSA) of at least 20%
- Have a minimum Eczema Area and Severity Index (EASI) score of at least 15
Who cannot join
- Mild atopic dermatitis as defined by IGSA score of 0 (clear), 1 (almost clear), or 2 (mild) OR %BSA affected less than 20% OR EASI Score of less than 15.
- Clinically infected atopic dermatitis at the baseline visit. Tacrolimus is not indicated for the treatment of clinically infected atopic dermatitis
- Any dermatological condition other than atopic dermatitis that in the Investigator's opinion may interfere with the evaluation of the patient's atopic dermatitis
- Females who are pregnant, lactating or likely to become pregnant during the study.
- History of allergy or sensitivity to tacrolimus, pimecrolimus, any macrolides such as clindamycin erythromycin
- Current diagnosis or history or any disease, which in the Investigators opinion would contraindicate the use of immunosuppressants, including but not limited to human immunodeficiency virus (HIV) and cancer.
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- Use of any nonsteroidal immunosuppressants
- Regular use of intranasal or inhaled corticosteroids, greater than the equivalent of 2 mg of prednisone/day, within 14 days of the first dosing day.
- Use of non-sedating histamines are not allowed for at least 7 days prior to the first dosing day or throughout the study.
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Clinical Study to Evaluate the Bioequivalence of Two Tacrolimus 0.1% Topical Ointment Formulations in Patients With Moderate to Severe Atopic Dermatitis
The primary objectives are to establish the therapeutic equivalence of tacrolimus ointment 0.1%, manufactured by Taro Pharmaceuticals Inc. and Protopic® (tacrolimus), 0.1% topical ointment (Astellas Pharma US, Inc.) and to show superiority over vehicle in the treatment of moderate to severe atopic dermatitis.
The secondary objectives are to compare the adverse event (AE) profiles of the two ointments and to investigate their systemic absorption at steady state.
- Conditions
- Atopic Dermatitis
- Being tested
- Tacrolimus 0.1% manufactured by Taro, Protopic - Tacrolimus 0.1%, Tacrolimus Vehicle manufactured by Taro
- Keywords
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus 0.1% manufactured by TaroDrug
Treatment applied as a thin layer to target area twice daily for 14 days
Protopic - Tacrolimus 0.1%Drug
Treatment applied as a thin layer to target area twice daily for 14 days
Tacrolimus Vehicle manufactured by TaroDrug
Treatment applied as a thin layer to target area twice daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus 0.1% Taro | Experimental | Tacrolimus 0.1% manufactured by Taro applied for 14 days Receives: Drug: Tacrolimus 0.1% manufactured by Taro |
| Protopic - Tacrolimus 0.1% | Active comparator | Protopic, Tacrolimus 0.1% applied for 14 days Receives: Drug: Protopic - Tacrolimus 0.1% |
| Vehicle | Placebo comparator | Tacrolimus vehicle applied for 14 days Receives: Drug: Tacrolimus Vehicle manufactured by Taro |
What is being measured
The primary outcome is the main question the study is designed to answer.
ISGA score 0 or 1
Measured: 14 days
Secondary outcomes (4)
% change in BSA
Measured: 14 days
% change in EASI
Measured: 14 days
% change in ISGA
Measured: 14 days
Safety and adverse event profile
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionFeb 2010
- Study completionMar 2010
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833079
- Sponsor's protocol ID
- TACR-0707
- Status last verified
- Jan 2014
- First submitted
- 28 Jan 2009
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Clinical Study to Evaluate the Bioequivalence of Two Tacrolimus 0.1% Topical Ointment Formulations in Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00833079
- Acronym / sponsor ID
- TACR-0707
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 30 Jan 2009 (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 primary objectives are to establish the therapeutic equivalence of tacrolimus ointment 0.1%, manufactured by Taro Pharmaceuticals Inc. and Protopic® (tacrolimus), 0.1% topical ointment (Astellas Pharma US, Inc.) and to show superiority over vehicle in the treatment of moderate to severe atopic dermatitis.
The secondary objectives are to compare the adverse event (AE) profiles of the two ointments and to investigate their systemic absorption at steady state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus 0.1% Taro | Experimental | Drug: Tacrolimus 0.1% manufactured by TaroTacrolimus 0.1% manufactured by Taro applied for 14 days |
| Protopic - Tacrolimus 0.1% | Active comparator | Drug: Protopic - Tacrolimus 0.1%Protopic, Tacrolimus 0.1% applied for 14 days |
| Vehicle | Placebo comparator | Drug: Tacrolimus Vehicle manufactured by TaroTacrolimus vehicle applied for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or non-pregnant, non-lactating female, 18 years of age or older.
- Patient has documented evidence that they have been unresponsive to alternative more traditional therapies such as topical corticosteroids, or in the investigators opinion, such first line therapy would be deemed inadvisable because of potential risks to the patient.
- If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, IUD, oral, transdermal, injected or implanted hormonal contraceptives).
- Have confirmed diagnosis of atopic dermatitis using the diagnostic features as described by Hanifin and Rajka.
- Have an IGSA score of 3 (moderate) or 4 (severe)
Key exclusion criteria (9 listed)
- Mild atopic dermatitis as defined by IGSA score of 0 (clear), 1 (almost clear), or 2 (mild) OR %BSA affected less than 20% OR EASI Score of less than 15.
- Clinically infected atopic dermatitis at the baseline visit. Tacrolimus is not indicated for the treatment of clinically infected atopic dermatitis
- Any dermatological condition other than atopic dermatitis that in the Investigator's opinion may interfere with the evaluation of the patient's atopic dermatitis
- Females who are pregnant, lactating or likely to become pregnant during the study.
- History of allergy or sensitivity to tacrolimus, pimecrolimus, any macrolides such as clindamycin erythromycin
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 |
|---|---|---|
| Tacrolimus 0.1% manufactured by TaroTreatment applied as a thin layer to target area twice daily for 14 days | Drug | Tacrolimus 0.1% Taro |
| Protopic - Tacrolimus 0.1%Treatment applied as a thin layer to target area twice daily for 14 days | Drug | Protopic - Tacrolimus 0.1% |
| Tacrolimus Vehicle manufactured by TaroTreatment applied as a thin layer to target area twice daily for 14 days | Drug | Vehicle |
Primary outcome
ISGA score 0 or 1
Time frame: 14 days
4 secondary outcomes
% change in BSA
Time frame: 14 days
% change in EASI
Time frame: 14 days
% change in ISGA
Time frame: 14 days
Safety and adverse event profile
Time frame: 14 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 22 Jan 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tacrolimus 0.1% manufactured by Taro and Protopic - Tacrolimus 0.1% in people with Atopic Dermatitis, run by Sun Pharmaceutical Industries, Inc..
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 9 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 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
ISGA score 0 or 1 (time frame: 14 days). 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 22 Jan 2014.