Low-Dose (17.5 mg/Day) Acitretin: Comparable Efficacy Without the Side Effects?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Frankel, Amylynne, M.D..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Stiefel, a GSK Company
Information provided by:
Frankel, Amylynne, M.D.
ClinicalTrials.gov Identifier:
NCT01228409
First received: October 21, 2010
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: Acitretin 17.5 mg/day
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Frankel, Amylynne, M.D.:

Primary Outcome Measures:
  • Improvement in psoriasis [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • Subjective efficacy/tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Subjective efficacy/tolerability questionnaires for every subject at the end of the study


Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Low dose Acitretin (17.5 mg) Drug: Acitretin 17.5 mg/day
lower dose of Acitretin to 17.5 mg/day from 25 mg/day in those experiencing retinoid-related side effects
Other Name: soriatane, acitretin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228409

Contacts
Contact: Amylynne J Frankel, MD 212-241-3288 Amylynne.Frankel@mssm.edu

Locations
United States, New York
Mount Sinai Clinical Trials Recruiting
New York, New York, United States, 10065
Contact: Giselle K Singer, MD    212-241-3288    Giselle.Singer@mssm.edu   
Principal Investigator: Amylynne J Frankel, MD         
Sponsors and Collaborators
Frankel, Amylynne, M.D.
Stiefel, a GSK Company
  More Information

No publications provided

Responsible Party: Amylynne Frankel, MD, Dermatopharmacology Fellow, Mount Sinai School of Medicine, Department of Dermatology
ClinicalTrials.gov Identifier: NCT01228409     History of Changes
Other Study ID Numbers: FDAAA 10-0093
Study First Received: October 21, 2010
Last Updated: June 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Frankel, Amylynne, M.D.:
Psoriasis
phototherapy
soriatane
acitretin
retinoid-related adverse events

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Acitretin
Keratolytic Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014