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Retinoid
Low-Dose Acitretin for Psoriasis
Phase 4
Waitlist Available
Research Sponsored by Frankel, Amylynne, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men must agree to use 2 forms of birth control (e.g. condoms, spermicide)
Adherence to alcohol avoidance during acitretin therapy and for 2 months after discontinuation of acitretin
Must not have
Guttate, erythrodermic, or pustular psoriasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Summary
This trial is looking at whether a lower dose of acitretin, a drug used to treat psoriasis, is as effective as the standard dose, but causes fewer side effects.
Who is the study for?
Adults with severe plaque-type psoriasis already taking 25mg/day of Acitretin and experiencing side effects may qualify. They must be on a stable phototherapy regimen, not use certain medications or have specific health conditions, avoid alcohol, agree to birth control measures, and commit to the study's duration without donating blood.
What is being tested?
The trial is testing if a lower dose of Acitretin (17.5 mg/day) can maintain effectiveness in treating severe plaque-type psoriasis while reducing side effects compared to the standard 25 mg/day dosage.
What are the potential side effects?
Potential side effects include hair loss, dryness in mouth/nose/eyes/skin, itching, sensitivity to light, liver issues, changes in blood fats and cholesterol levels, joint and muscle pain, eye problems like irritation or inflammation (conjunctivitis), headaches, nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use two forms of birth control.
Select...
I will not drink alcohol while on acitretin and for 2 months after stopping it.
Select...
I am a woman who cannot become pregnant due to surgery or menopause.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My psoriasis is guttate, erythrodermic, or pustular.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Improvement in psoriasis
Secondary study objectives
Subjective efficacy/tolerability
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Low dose Acitretin (17.5 mg)Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Stiefel, a GSK CompanyIndustry Sponsor
60 Previous Clinical Trials
12,739 Total Patients Enrolled
11 Trials studying Psoriasis
1,457 Patients Enrolled for Psoriasis
Frankel, Amylynne, M.D.Lead Sponsor
2 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't used topical vitamin A, D, or similar creams in the last 2 weeks.I agree to use two forms of birth control.I have been on a stable light therapy plan for 4 weeks.I haven't taken any immune system suppressing drugs in the last 4 weeks.I have not used any experimental drugs or treatments in the last 4 weeks.I am a woman who could become pregnant.I am 18 years old or older.I have not had a major illness in the last 30 days.I understand the study and agree to participate by signing the consent form.I am taking 25 mg of acitretin daily and having side effects that may improve with a lower dose.I am not on medication that could interfere with the study.I can follow the study's requirements and complete it.I have used over-the-counter drugs or herbal remedies within the last 2 weeks.I will not drink alcohol while on acitretin and for 2 months after stopping it.You have a weakened immune system.You have a history of or are currently misusing alcohol or drugs.I am a woman who cannot become pregnant due to surgery or menopause.My liver function is severely impaired, more than three times the normal limit.You have uncontrolled high levels of triglycerides in your blood.My psoriasis is guttate, erythrodermic, or pustular.
Research Study Groups:
This trial has the following groups:- Group 1: Low dose Acitretin (17.5 mg)
Awards:
This trial has 5 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.