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Taclonex Ointment With Hydrogel Patch Occlusion for the Treatment of Psoriasis

Primary Purpose

Plaque Psoriasis, Psoriasis Vulgaris

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Taclonex Ointment and Hydrogel Patch

Taclonex Ointment

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring 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.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

UCSF Psoriasis Skin and Treatment Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Taclonex Ointment/Hydrogel Patch Applied Topically Once Daily

Taclonex Ointment Topically Once Daily

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT00924950

First Posted

June 17, 2009

Last Updated

April 16, 2019

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT00924950

Brief Title

Taclonex Ointment With Hydrogel Patch Occlusion for the Treatment of Psoriasis

Official Title

An Open-Label, Bilaterally-Controlled Single Center Study to Compare the Efficacy of Taclonex Ointment With Hydrogel Patch Occlusion to Taclonex Ointment Without Occlusion in the Treatment of Plaque-Type Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Terminated

Study Start Date

June 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This will be an open label, bilaterally-controlled single center study. Thirty subjects with plaque type psoriasis will be enrolled in the study. All subjects will receive treatment on two target lesions that are similar in erythema, scaling and induration, and symmetric in anatomic location. The severity of their target lesions will be assessed using a modified Psoriasis Area and Severity Index (PASI) scoring system (Appendix A). Symmetrical target lesions must each be rated at a PASI score equal to or greater than 7 and be within 1 PASI score of each other. All subjects will apply Taclonex ointment to both target lesions once daily for 4 weeks. The occlusive dressing will be applied by the subject to one of the two symmetrical target lesions once daily for 4 weeks. The occlusive dressing will be removed by the patient if he/she experiences warmth, irritation, increased erythema, and/or itching. If the patch is removed due to these symptoms and signs, the subject will leave the lesion un-occluded until for 24 hours, at which time a new occlusive dressing will be placed. After the initial 4 weeks of treatment, there will be a follow up period of 6 weeks during which no treatment is used. Subjects will be restricted from using systemic therapies for psoriasis during this study, including Psoralen Ultraviolet A (PUVA) photochemotherapy and herbal therapies. All topical medications, except the study medications, and UVB phototherapy are prohibited on the target lesions. All of the other psoriasis lesions on the body can be treated as usual with other topical medications and Ultraviolet B (UVB) phototherapy as long as it does not impact on the two target lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Taclonex Ointment/Hydrogel Patch Applied Topically Once Daily

Arm Type

Active Comparator

Arm Description

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

Arm Title

Taclonex Ointment Topically Once Daily

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Taclonex Ointment and Hydrogel Patch

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Taclonex Ointment

Intervention Description

Taclonex ointment daily for one psoriatic plaque.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

6 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Koo, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSF Psoriasis Skin and Treatment Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94118

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

7534777

Citation

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.

Results Reference

background

PubMed Identifier

15663344

Citation

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.

Results Reference

background

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Taclonex Ointment With Hydrogel Patch Occlusion for the Treatment of Psoriasis

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