PsoriasisPhase 4NCT01228409
Low-Dose (17.5 mg/Day) Acitretin: Comparable Efficacy Without the Side Effects?
A Phase 4 study testing Acitretin 17.5 mg/day in people with Psoriasis, run by Frankel, Amylynne, M.D. at 1 site in United States.
Trial summary
Psoriasis is a chronic skin disorder with a prevalence of approximately 1-3% worldwide. At present, there is no curative therapy available and the clinical course is unpredictable, but in the majority of cases psoriasis is a chronically remitting and relapsing disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Psoriasis
- What is being tested?
- Acitretin 17.5 mg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2011
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 18 years of age or older.
- Surgically sterile females. Females who have had a hysterectomy or oophorectomy or completed menopause (post-menopausal for at least 1 year) are allowed. Men must agree to use 2 forms of birth control (eg condoms, spermicide).
- Stabilized on a phototherapy regimen for 4 weeks.
- Compliant with acitretin dosing at 25 mg/day and experiencing retinoid-related adverse events which, in the clinical judgement of the investigator, may benefit from a reduction in dose to 17.5 mg/day.
- Able to complete the study and to comply with the study instructions.
- Adherence to alcohol avoidance during acitretin therapy and for 2 months after discontinuation of acitretin.
- Subjects must be willing to not donate blood during the study as well as 3 years following completion of this study.
- Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.
Who cannot join
- Uncontrolled hypertriglyceridemia.
- Guttate, erythrodermic, or pustular psoriasis.
- Severely impaired hepatic function, > 3 times the upper limit of normal and the clinical investigator's judgment.
- Use of systemic immunosuppressant agents (eg. Methotrexate, cyclosporine, thioguanine, azathioprine, alefacept, egalizumab, corticosteroids) within 4 weeks of baseline and throughout the study.
- Topical vitamin A, vitamin D or analogue preparations, or anthralin within 2 weeks of study initiation.
- History of known or suspected intolerance to any of the ingredients of the investigational study product.
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- Used over the counter (non-prescription) medications or herbal remedies within 2 weeks of dosing, unless agreed upon as not clinically relevant by the principal investigator.
- Participated in a previous study of the same study product.
- Currently using any medication which, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
- Currently suffering from any disease or condition which, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
- Any major illness within 30 days before screening examination.
- Considered immunocompromised.
- A clinically relevant history of or current evidence of abuse of alcohol or other drugs.
- Use of any investigational drugs or treatments during the study or within 4 weeks of the baseline visit.
- Women of child-bearing potential (see inclusion criteria).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Clinical Trials
New York, New York, 10065
Giselle K Singer, MD, 212-241-3288, Giselle.Singer@mssm.edu
Amylynne J Frankel, MD
About this study
Official title: An Open Label Trial to Show That Subjects With Severe Plaque-Type Psoriasis Receiving Acitretin 25 mg/Day And Stabilized On A Photochemotherapy Regimen Who Are Experiencing Retinoid-Related Adverse Events, Benefit From A Reduction In Acitretin Dose to 17.5 mg/Day, While Maintaining Comparable Efficacy Along With Improved Tolerability
Psoriasis is a chronic skin disorder with a prevalence of approximately 1-3% worldwide. At present, there is no curative therapy available and the clinical course is unpredictable, but in the majority of cases psoriasis is a chronically remitting and relapsing disease. Several clinical subtypes of psoriasis exist with differences in manifestations and skin areas involved.
Chronic stable plaque psoriasis (Psoriasis Vulgaris) is the commonest form of the disease, accounting for 85-90% of cases. The circumscribed infiltrated skin lesions are scaly and erythematous and often symmetrically distributed over the body. Several types of palliative therapies exist. The therapies are either topical or systemic. The severity of chronic plaque psoriasis is often determined by the percentage of body surface area (BSA) involved. For mild, moderate and severe chronic plaque psoriasis with BSA involvement of up to 20%, initial therapy is topical. Phototherapy and numerous systemic therapies are usually indicated when more than 20% of skin is affected.
Read more
Severe plaque-type psoriasis requires systemic and long-term therapy in order to induce and maintain remission. Acitretin 25mg/day combined with a phototherapy regimen is a standard treatment that provides clinically significant efficacy, however many patients experience tolerability issues due to retinoid-related adverse events. Retinoid-related adverse events include but are not limited to: alopecia, dry mucus membranes, pruritus, photosensitivity, elevation of liver enzymes, elevation of serum triglycerides, cholesterol and decrease of HDL, arthralgias, myalgias, eye irritation, blepharitis, photophobia, conjunctivitis, headaches, nausea, anemia and leukemia. Reducing the acitretin dose from 25mg/day to 17.5mg/day may provide improved tolerability without compromising efficacy.
The purpose of this study is to ascertain if reducing the acitretin dose from 25mg/day to 17.5mg/day will provide improved tolerability without compromising efficacy.
- Conditions
- Psoriasis
- Being tested
- Acitretin 17.5 mg/day
- Keywords
- Psoriasis, phototherapy, soriatane, acitretin, retinoid-related adverse events
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acitretin 17.5 mg/dayDrug
Also called soriatane, acitretin
lower dose of Acitretin to 17.5 mg/day from 25 mg/day in those experiencing retinoid-related side effects
| Study group | Role | What they receive |
|---|---|---|
| Low dose Acitretin (17.5 mg) | Other | Not described Receives: Drug: Acitretin 17.5 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in psoriasis
Improvement and maintenance of Psoriasis Area Severity Index (PASI), Body Surface Area (BSA), Physician's Global Assessment (PGA), and Psoriasis Disability Index and Dermatology Life Quality Index (DLQI)
Measured: 12 weeks
Secondary outcomes (1)
Subjective efficacy/tolerability
Subjective efficacy/tolerability questionnaires for every subject at the end of the study
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frankel, Amylynne, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Stiefel, a GSK Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228409
- Sponsor's protocol ID
- FDAAA 10-0093
- Status last verified
- Jun 2011
- First submitted
- 21 Oct 2010
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Trial to Show That Subjects With Severe Plaque-Type Psoriasis Receiving Acitretin 25 mg/Day And Stabilized On A Photochemotherapy Regimen Who Are Experiencing Retinoid-Related Adverse Events, Benefit From A Reduction In Acitretin Dose to 17.5 mg/Day, While Maintaining Comparable Efficacy Along With Improved Tolerability
- ClinicalTrials.gov ID
- NCT01228409
- Acronym / sponsor ID
- FDAAA 10-0093
- Conditions
- Psoriasis
- Keywords
- Psoriasis, phototherapy, soriatane, acitretin, retinoid-related adverse events
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Frankel, Amylynne, M.D.University, hospital or other
- Collaborators
- Stiefel, a GSK Company
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (estimated)
- First posted
- 26 Oct 2010 (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.
Psoriasis is a chronic skin disorder with a prevalence of approximately 1-3% worldwide. At present, there is no curative therapy available and the clinical course is unpredictable, but in the majority of cases psoriasis is a chronically remitting and relapsing disease. Several clinical subtypes of psoriasis exist with differences in manifestations and skin areas involved.
Chronic stable plaque psoriasis (Psoriasis Vulgaris) is the commonest form of the disease, accounting for 85-90% of cases. The circumscribed infiltrated skin lesions are scaly and erythematous and often symmetrically distributed over the body. Several types of palliative therapies exist. The therapies are either topical or systemic. The severity of chronic plaque psoriasis is often determined by the percentage of body surface area (BSA) involved. For mild, moderate and severe chronic plaque psoriasis with BSA involvement of up to 20%, initial therapy is topical. Phototherapy and numerous systemic therapies are usually indicated when more than 20% of skin is affected.
Severe plaque-type psoriasis requires systemic and long-term therapy in order to induce and maintain remission. Acitretin 25mg/day combined with a phototherapy regimen is a standard treatment that provides clinically significant efficacy, however many patients experience tolerability issues due to retinoid-related adverse events. Retinoid-related adverse events include but are not limited to: alopecia, dry mucus membranes, pruritus, photosensitivity, elevation of liver enzymes, elevation of serum triglycerides, cholesterol and decrease of HDL, arthralgias, myalgias, eye irritation, blepharitis, photophobia, conjunctivitis, headaches, nausea, anemia and leukemia. Reducing the acitretin dose from 25mg/day to 17.5mg/day may provide improved tolerability without compromising efficacy.
The purpose of this study is to ascertain if reducing the acitretin dose from 25mg/day to 17.5mg/day will provide improved tolerability without compromising efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low dose Acitretin (17.5 mg) | Other | Drug: Acitretin 17.5 mg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects 18 years of age or older.
- Surgically sterile females. Females who have had a hysterectomy or oophorectomy or completed menopause (post-menopausal for at least 1 year) are allowed. Men must agree to use 2 forms of birth control (eg condoms, spermicide).
- Stabilized on a phototherapy regimen for 4 weeks.
- Compliant with acitretin dosing at 25 mg/day and experiencing retinoid-related adverse events which, in the clinical judgement of the investigator, may benefit from a reduction in dose to 17.5 mg/day.
- Able to complete the study and to comply with the study instructions.
Key exclusion criteria (15 listed)
- Uncontrolled hypertriglyceridemia.
- Guttate, erythrodermic, or pustular psoriasis.
- Severely impaired hepatic function, > 3 times the upper limit of normal and the clinical investigator's judgment.
- Use of systemic immunosuppressant agents (eg. Methotrexate, cyclosporine, thioguanine, azathioprine, alefacept, egalizumab, corticosteroids) within 4 weeks of baseline and throughout the study.
- Topical vitamin A, vitamin D or analogue preparations, or anthralin within 2 weeks of study initiation.
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 |
|---|---|---|
| Acitretin 17.5 mg/dayAlso: soriatane, acitretinlower dose of Acitretin to 17.5 mg/day from 25 mg/day in those experiencing retinoid-related side effects | Drug | Low dose Acitretin (17.5 mg) |
Primary outcome
Improvement in psoriasis
Time frame: 12 weeks
Improvement and maintenance of Psoriasis Area Severity Index (PASI), Body Surface Area (BSA), Physician's Global Assessment (PGA), and Psoriasis Disability Index and Dermatology Life Quality Index (DLQI)
1 secondary outcome
Subjective efficacy/tolerability
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acitretin 17.5 mg/day in people with Psoriasis, run by Frankel, Amylynne, M.D. at 1 site in United States.
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 8 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: status not confirmed, as of the sponsor's last update on 22 Jun 2011. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amylynne J Frankel, MD (212-241-3288, Amylynne.Frankel@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in psoriasis (time frame: 12 weeks). 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 Jun 2011.