A Pilot Study of Alefacept for the Treatment of Pityriasis Rubra Pilaris
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00815633 |
Recruitment Status
:
Terminated
(Failed to enroll patients)
First Posted
: December 30, 2008
Last Update Posted
: November 10, 2009
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pityriasis Rubra Pilaris | Drug: Alefacept | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Study of Alefacept for the Treatment of Pityriasis Rubra Pilaris. |
Study Start Date : | December 2008 |
Estimated Primary Completion Date : | December 2009 |
Estimated Study Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Alefacept
Treatment Group (only one group)
|
Drug: Alefacept
15mg intramuscular injection weekly for 12 weeks
Other Name: Amevive
|
- Evidence of skin change - Physician's Global Assessment (PGA) [ Time Frame: wks 1,2,3,4,5,6,7,8,9,10,11,12, 16,20,24 ]
- Evidence of skin change - PRP Area and Severity Index (PASI) [ Time Frame: wks 1,2,3,4,5,6,7,8,9,10,11,12, 16,20,24 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects may be male or female, 30 years old or older at time of consent
- Have a diagnosis of pityriasis rubra pilaris at least 6 months prior to administration of the first dose of the study medication
- Be a candidate for systemic therapy
- Women of childbearing potential and all men must use adequate contraceptive measures if sexually active. Examples include abstinence, oral contraceptives or other form of hormonal contraception, intrauterine devices, surgical sterilization, or barrier forms of contraception with spermicidal jelly. Subjects must agree to continue to use these contraceptive measures and agree not to become or plan a pregnancy within 12 months of the date of the last study drug administration.
- Agree to adhere to the study visit schedule and protocol requirements, including blood draws and clinical photographs.
- Must be able to give informed consent, and this consent must be obtained prior to any study related procedures being performed.
- Must avoid other treatment modalities during the course of the study and adhere to standard washout periods for any medications used to treat their skin prior to receiving the first dose of study medication.
- Must agree not to receive a live viral or bacterial vaccine during the course of the study or for 12 months after the date of the last study drug administration.
- Have screening blood tests that are stable as deemed by the physician investigator. AST, ALT and alkaline phosphatase levels must be within 2.0 times the upper limit of normal to participate.
Exclusion Criteria:
- Subjects are pregnant or planning a pregnancy (both men and women) while enrolled in the study.
- Have used the medication alefacept in the past.
- Have used another investigational medication within the past 4 weeks or within 5 times the half-life of that investigational medicine.
- Have received systemic medications that could affect pityriasis rubra pilaris within 4 weeks of administration of the first dose of the study medicine.
- Have used topical medications that could affect pityriasis rubra pilaris within 2 weeks of administration of the first dose of the study medicine.
- Have received a live viral or bacterial vaccine within 3 months of administration of the first dose of the study medicine.
- Have a history of chronic or recurrent infections of the skin or internal organs.
- Have had a serious infection requiring hospitalization or intravenous antibiotics within 2 weeks of administration of the first dose of the study medicine.
- Have a history of latent untreated tuberculosis.
- Have a known history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
- Have a history of a malignancy except for squamous cell or basal cell carcinoma of the skin or cervical carcinoma in situ that has been treated with no evidence of recurrence.
- Have a known hypersensitivity to any component of alefacept.
- Have a known substance abuse problem or is deemed by the investigator as unable to follow the study protocol.
- Is participating in another study for an investigational agent or procedure during the course of this study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00815633
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 |
Principal Investigator: | Joshua Zeichner, MD | Icahn School of Medicine at Mount Sinai |
Responsible Party: | Joshua Zeichner, MD, Mount Sinai School of Medicine |
ClinicalTrials.gov Identifier: | NCT00815633 History of Changes |
Other Study ID Numbers: |
08-0514 JM-08-001 |
First Posted: | December 30, 2008 Key Record Dates |
Last Update Posted: | November 10, 2009 |
Last Verified: | November 2009 |
Keywords provided by Icahn School of Medicine at Mount Sinai:
PRP Pityriasis Rubra Pilaris Amevive Alefacept |
Biologic Immunosuppressant Severe skin disease |
Additional relevant MeSH terms:
Pityriasis Dermatitis, Exfoliative Pityriasis Rubra Pilaris Skin Diseases, Papulosquamous Skin Diseases |
Dermatitis Skin Diseases, Eczematous Alefacept Dermatologic Agents |