Taclonex Ointment With Hydrogel Patch Occlusion for the Treatment of Psoriasis

NCT00924950 | Terminated Phase 4 Results

• 1 other identifier: H5939-31328-02
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether using Taclonex ointment under a hydrogel patch is more effective than using the ointment alone in treating psoriasis. Taclonex ointment is currently FDA approved for use on psoriasis. The hydrogel patch is a type of adhesive pad and contains no medications. It is currently FDA approved and has been shown to be safe and virtually free of side effects. The hypothesis is that psoriatic plaques which are treated with Taclonex ointment under a hydrogel patch will be more effectively treated compared to psoriatic plaques treated with Taclonex alone.

Conditions

Plaque Psoriasis; Psoriasis Vulgaris

Keywords

Psoriasis; Plaque psoriasis, with bilateral symmetrical lesions.; A diagnosis of stable plaque-type psoriasis vulgaris; with at least one pair of symmetric lesions on either; the trunk, arms, or legs that would serve as target lesions.

Outcome Measures

Primary Outcomes (1)

• Change in Total Modified PASI Score at Week 4 Compared to Baseline

  Modified psoriasis severity index measures erythema, induration, and scaling each measured from 0-4, with a maximum summed score of 12. A higher score means greater psoriasis severity and a lower score means lower psoriasis severity.

  4 weeks

Secondary Outcomes (1)

• Change in Modified PASI Scores Between Week 4 and Week 6 During the Follow-up Period. This is to Determine Whether There is Further Improvement of Psoriasis After the Cessation of Occlusion

  6 Weeks

Study Arms (2)

Taclonex Ointment/Hydrogel Patch Applied Topically Once Daily

ACTIVE COMPARATOR

Taclonex ointment once daily used to treat one psoriatic plaque, along with the Hydrogel Patch used once daily.

Drug: Taclonex Ointment and Hydrogel Patch

Taclonex Ointment Topically Once Daily

ACTIVE COMPARATOR

Drug: Taclonex Ointment

Interventions

Taclonex Ointment and Hydrogel Patch DRUG

Each patient will have bilateral symmetrical psoriatic plaques. One plaque will be treated with Taclonex Ointment daily along with Hydrogel Patch daily. All treatment will be for 4 weeks.

Taclonex Ointment/Hydrogel Patch Applied Topically Once Daily

Taclonex Ointment DRUG

Taclonex ointment daily for one psoriatic plaque.

Taclonex Ointment Topically Once Daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has signed the informed consent form and Health Information Portability and Accountability Act (HIPAA) authorization form;
• Male or female subject at least 18 years of age;
• A diagnosis of stable plaque-type psoriasis vulgaris with at least one pair of symmetric lesions on either the trunk, arms, or legs that would serve as target lesions. Paired target lesions must be in similar anatomic locations (e.g., right and left elbows or right and left knees) and have roughly equivalent (no more than one point difference) modified Psoriasis Area Severity Index (PASI) scores. Each paired target lesions must have PASI scores equal to or greater than 7;
• Any additional diagnoses must, in the investigator's opinion, not preclude the subject from safely participating in this study or interfere with the evaluation of the subject's psoriasis;
• Psoriasis must be clinically stable for at least 30 days before enrollment;
• Subject is able to discontinue the use of any medication or therapy for relief of psoriasis in the target areas to be treated;
• Subject is able to discontinue the use of any systemic medication or therapy (e.g. oral or injectable psoriasis medications, PUVA photochemotherapy, herbal remedies, etc.) for psoriasis;
• Subject must be reliable and mentally competent to complete study measurements;
• Subject is able to understand and agrees to comply with study requirements, attend study visits, and comply with the restrictions during the study.

You may not qualify if:

• Subject has a skin disorder other than psoriasis in the target areas to be evaluated;
• Known hypersensitivity to any component of the test medications;
• Pigmentation, extensive scarring, or pigmented lesions in affected areas that would interfere with evaluation of efficacy parameters;
• Clinically infected psoriasis at baseline;
• Guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis;
• Spontaneously worsening or improving psoriasis within 30 days of enrollment;
• Any evidence of atrophy in the areas selected for treatment with topical corticosteroid;
• Topical or intralesional therapies (other than emollients) or UVB phototherapy on potential target lesions within two weeks of starting study treatment;
• Systemic therapy, PUVA phototherapy, or a systemic investigational therapy for psoriasis within 30 days prior to study entry;
• Treatment with topical investigational therapy of the target lesions within 30 days prior to study entry;
• Subject is considered unreliable as to medication compliance or adherence to scheduled appointments as determined by the investigators.
• Subject is pregnant

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Psoriasis Skin and Treatment Center

San Francisco, California, 94118, United States

Location

Related Publications (2)

• Griffiths CE, Tranfaglia MG, Kang S. Prolonged occlusion in the treatment of psoriasis: a clinical and immunohistologic study. J Am Acad Dermatol. 1995 Apr;32(4):618-22. doi: 10.1016/0190-9622(95)90347-x.

  PMID: 7534777 BACKGROUND

• Fenton C, Plosker GL. Calcipotriol/betamethasone dipropionate: a review of its use in the treatment of psoriasis vulgaris. Am J Clin Dermatol. 2004;5(6):463-78. doi: 10.2165/00128071-200405060-00012.

  PMID: 15663344 BACKGROUND

MeSH Terms

Conditions

Psoriasis; Rhabdomyosarcoma, Alveolar

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Rhabdomyosarcoma; Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Results Point of Contact

• Title: Tina Bhutani
• Organization: UCSF

tinabhutanimd@gmail.com

4154763396

Study Officials

• John Koo, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 19, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 18, 2019
• Results First Posted: December 5, 2012

Record last verified: 2019-04

Locations

US (1)