Efficacy and Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa
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ClinicalTrials.gov Identifier: NCT00134134 |
Recruitment Status
:
Completed
First Posted
: August 24, 2005
Last Update Posted
: September 11, 2006
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hidradenitis Suppurativa | Drug: efalizumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 5 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label Assessment of the Efficacy & Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa |
Study Start Date : | February 2005 |
Study Completion Date : | August 2006 |

- Reduction in number of inflammatory lesions 12 weeks post-baseline
- Time to the reduction of lesions during 12 weeks of treatment
- Percent of disease activity at various weeks after baseline

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female between 18-65 years of age
- Has Hydradenitis Suppurativa (HS) involving at least 1 area of the body with greater than or equal to 12 lesions; onset of disease is 6 months and greater.
- Failed at least 3 months of standard conventional therapies such as antibiotics and/or systemic retinoids
- Willing to use contraception unless not of childbearing potential
- Able to comply with protocol requirements
Exclusion Criteria:
- Received within 4 weeks prior immunosuppressive medication
- Received treatment within 3 months prior with systemic retinoids (acitretin or isotretinoin)
- Received high potency (class I or II) topical corticoid steroids, topical antibiotics, systemic antibiotics, or topical immunomodulators (tacrolimus or pimecrolimus) within 2 weeks prior to baseline visit
- Received intralesional injections of corticosteroids within 4 weeks prior
- Received surgical intervention for the treatment of HS
- Known history of HIV seropositivity
- History of untreated or active tuberculosis
- Active infection requiring systemic antibiotics within 4 weeks of baseline visit
- History of recurrent/chronic infections
- History of malignancy within 5 years of baseline visit (except for squamous cell carcinoma or basal cell carcinoma; may enroll if treated and assessed as cured).
- Pregnant or breastfeeding
- Immunocompromised due to a medical condition
- Has any significant laboratory abnormalities
- Has any medical condition that may interfere with evaluation of the safety and efficacy of efalizumab
- Received efalizumab or any other biologic within the last 6 months
- Taken or used any investigational drug or device within 30 days prior

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): NCT00134134
United States, New York | |
New York University School of Medicine, Dept of Dermatology | |
New York, New York, United States, 10016 |
Principal Investigator: | Bruce Strober, MD, PhD | New York University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00134134 History of Changes |
Other Study ID Numbers: |
H12452-01B |
First Posted: | August 24, 2005 Key Record Dates |
Last Update Posted: | September 11, 2006 |
Last Verified: | September 2006 |
Keywords provided by New York University School of Medicine:
hidradenitis suppurativa efalizumab biologic Raptiva |
Additional relevant MeSH terms:
Hidradenitis Hidradenitis Suppurativa Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial Bacterial Infections |
Skin Diseases, Infectious Infection Suppuration Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |