Anti-Inflammatory Effects of 0.045% Tazarotene/0.01% Halobetasol Lotion in Psoriasis

November 15, 2023 updated by: Dermatology Consulting Services, PLLC

A Demonstration of the Anti-Inflammatory Effects of 0.045% Tazarotene/0.01% Halobetasol Lotion as Compared to 0.05% Clobetasol Propionate Cream in the Treatment of Psoriasis

The objective of this research is to demonstrate superior anti-inflammatory effects, as demonstrated by a reduction in TNF-a and IL-17A, with tazarotene/halobetasol lotion in patients with mild to moderate plaque type psoriasis as compared to clobetasol propionate 0.05% cream.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Male or female subjects with mild to moderate plaque type psoriasis will present to the research center for evaluation for study entry. They will have been advised to present to the research center with clean skin and no topical products applied to the body, including medications, moisturizers, sunscreens, etc. If found to be suitable by meeting all inclusion criteria and none of the exclusion criteria, subjects will undergo selection of 2 target plaques by the dermatologist investigator. Each plaque will be graded for erythema, scaling, and induration. An Investigational Global Assessment (IGA) score will be assigned for each plaque. Plaques must have an IGA of mild (2) or moderate (3) to qualify for inclusion. The subjects will also assess each plaque for redness, thickness, and scaling. Each of the plaques will be photographed.The subjects will undergo D-squame tape strip removal of each of the 2 target psoriasis plaques. One plaque will serve as the tazarotene/halobetasol lotion treated plaque and the other will serve as the clobetasol propionate 0.05% cream treated plaque. 10 D-squames will be obtained with from each plaque. 5 tape strips will be placed in each glass jar. One jar will contain the even tape strips and the other jar will contain the odd tape strips. 10 D-squames will also be taken from normal skin to serve as a negative control in an individual without psoriasis. 5 tape strips will be placed in each glass jar. One jar will contain the even tape strips and the other jar will contain the odd tape strips. The D-squames will be frozen in a -80C freezer for later assessment. Five tape strips will be analyzed together to obtain adequate material for ELISA analysis. Two specimens jars will be prepared for from each of the 2 target plaques. One jar will be analyzed with the second jar serving as a back up.The subjects will have a number assigned to each of the treatment plaques. The numbers will be recorded on a body map. Two copies will be prepared. One copy will remain at the research center and the second copy will be provided to the subject. Each subject will receive one tube of tazarotene/halobetasol lotion for application to one randomized target plaque and a tube of clobetasol propionate 0.05% cream to apply the second randomized target plaque.Subjects will be provided with a diary. They will be instructed to apply the study product at bedtime to the designated target plaque. Care must be taken to apply the proper product to the proper plaque. Subjects will be instructed to return to the research center in 4 weeks. A reminder text for compliance will be provided prior to the week 4 visit.Subjects will return to the research center at week 4. The dermatologist investigator will evaluate each plaque for erythema, scaling, and induration. An Investigational Global Assessment (IGA) score will be assigned for each plaque. The subjects will also assess each plaque for redness, thickness, and scaling. Each of the plaques will be photographed. The subjects will undergo D-squame tape strip removal of 10 tape strips for each of the 2 target psoriasis plaques. Five tape strips will be placed in each jar with one jar receiving the even tape strips and the other jar receiving the odd tape strips. The D-squames will be frozen in a -80C freezer for later assessment. Subjects will discontinue treatment of the plaques at this time. All medication and study diaries will be collected. Subjects will be asked to return to the research center at week 8. A reminder text for compliance will be sent prior to the week 8 visit.Subjects will return to the research center at week 8. No treatment will be applied to the target plaques for the past 4 weeks. The dermatologist investigator will evaluate each plaque for erythema, scaling, and induration. An Investigational Global Assessment (IGA) score will be assigned for each plaque. The subjects will also assess each plaque for redness, thickness, and scaling. Each of the plaques will be photographed. The subjects will undergo D-squame tape strip removal 10 times for each of the 2 target psoriasis plaques. Five tape strips will be placed in each jar with one jar containing the even tape strips and the other jar containing the odd tape strips. The D-squames will be frozen in a -80C freezer for later assessment. Subjects will complete their study participation at this time.The D-squames will be analyzed using ELISA for the amount of TNF-a and IL-17A present after 4 weeks of treatment with tazarotene/halobetasol lotion to one randomized target plaque and clobetasol propionate 0.05% cream to apply the second randomized target plaque. Treatment will be discontinued at week 4 and subjects will remain untreated for the subsequent 4 weeks. At week 8, D-squames will be analyzed using ELISA for the amount of TNF-a and IL-17A present after 4 weeks off treatment with tazarotene/halobetasol lotion to one randomized target plaque and clobetasol propionate 0.05% cream to apply the second randomized target plaque. This research will allow comparison between a retinoid/topical corticosteroid combination and a topical corticosteroid alone in terms of inflammatory mediator reduction. It will also provide insight into the ability of a retinoid/topical corticosteroid combination to produce longer lasting inflammatory mediator reduction than a topical corticosteroid alone.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Dermatology Consulting Services, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Males or non-pregnant females 18+ years of age.
  2. Plaque type mild to moderate psoriasis suitable for topical treatment.
  3. The presence of 2 plaques suitable for tape stripping
  4. Subjects must be willing to allow a series of tape pieces to be pressed and removed from 2 target psoriasis plaques.
  5. Subjects must be in general good health as determined from a medical history.
  6. Subjects must read and sign the informed consent form after the nature of the study has been fully explained.

Exclusion Criteria:

  1. Subjects with known allergies or sensitivities to ingredients contained in the test products.
  2. Subjects with an allergy to latex or adhesives.
  3. Subjects with pustular or erythrodermic psoriasis.
  4. Subjects who are pregnant or nursing or planning to become pregnant during the course of the study.
  5. Subjects who are currently participating in any other clinical study (i.e., dermal patch, use tests, investigational drug or devices, etc.).
  6. Subjects viewed by the investigator as not being able to complete the study.
  7. Subjects using any type of lotion, medication, or other topical product to the psoriasis plaques.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 0.01% Halobetasol and 0.045% Tazarotene Lotion
0.01% Halobetasol and 0.045% Tazarotene Lotion (Duobrii)Applied to designated target plaque at bedtime.
Drug: 0.01% Halobetasol
Drug to be applied at bedtime to designated target psoriasis plaque at bedtime.
Drug: 0.045% Tazarotene
Drug to be applied in combination with 0.01% Halobetasol to the designated psoriasis plaque at bedtime.
Active Comparator: Clobetasol Propionate 0.05% Cream (generic)
Clobetasol Propionate 0.05% Cream (generic)Applied to designated target plaque at bedtime.
Drug: 0.05% Clobetasol Propionate
Drug to be applied to designated psoriatic plaque at bedtime.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Concentration of TNF-a and IL-17A in Psoriatic Plaques
Time Frame: 8 weeks
The primary outcome is to compare the concentration of TNF-a and/or IL-17A after discontinuing treatment for 4 weeks with tazarotene/halobetasol lotion as compared to clobetasol propionate 0.05% cream.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dermatology Consulting Services, PLLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DCS-69-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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