Low-Dose (17.5 mg/Day) Acitretin: Comparable Efficacy Without the Side Effects?
Public ClinicalTrials.gov record NCT01228409. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01228409
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2010
- Primary completion
- Nov 30, 2011
- Completion
- Not listed
- Last update posted
- Jun 21, 2011
Started 2010
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mount Sinai Clinical Trials | New York | New York | 10065 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01228409, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 21, 2011 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01228409 live on ClinicalTrials.gov.