Anti-Inflammatory Effects of 0.045% Tazarotene/0.01% Halobetasol Lotion in Psoriasis
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ClinicalTrials.gov Identifier: NCT06042647 |
Recruitment Status :
Completed
First Posted : September 18, 2023
Last Update Posted : November 18, 2023
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Condition or disease | Intervention/treatment | Phase |
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Psoriasis Vulgaris | Drug: 0.01% Halobetasol Drug: 0.045% Tazarotene Drug: 0.05% Clobetasol Propionate | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | One product applied to psoriasis on the right side of the body and a second product applied to the left side of the body. The right and left side product applications will be randomized. |
Masking: | Single (Investigator) |
Masking Description: | Investigator will not know which product is applied to the right and left psoriasis target plaque. |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | July 13, 2023 |
Actual Primary Completion Date : | November 13, 2023 |
Actual Study Completion Date : | November 13, 2023 |
Arm | Intervention/treatment |
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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.
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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.
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Drug: 0.05% Clobetasol Propionate
Drug to be applied to designated psoriatic plaque at bedtime. |
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Males or non-pregnant females 18+ years of age.
- Plaque type mild to moderate psoriasis suitable for topical treatment.
- The presence of 2 plaques suitable for tape stripping
- Subjects must be willing to allow a series of tape pieces to be pressed and removed from 2 target psoriasis plaques.
- Subjects must be in general good health as determined from a medical history.
- Subjects must read and sign the informed consent form after the nature of the study has been fully explained.
Exclusion Criteria:
- Subjects with known allergies or sensitivities to ingredients contained in the test products.
- Subjects with an allergy to latex or adhesives.
- Subjects with pustular or erythrodermic psoriasis.
- Subjects who are pregnant or nursing or planning to become pregnant during the course of the study.
- Subjects who are currently participating in any other clinical study (i.e., dermal patch, use tests, investigational drug or devices, etc.).
- Subjects viewed by the investigator as not being able to complete the study.
- Subjects using any type of lotion, medication, or other topical product to the psoriasis plaques.
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): NCT06042647
United States, North Carolina | |
Dermatology Consulting Services, PLLC | |
High Point, North Carolina, United States, 27262 |
Responsible Party: | Dermatology Consulting Services, PLLC |
ClinicalTrials.gov Identifier: | NCT06042647 |
Other Study ID Numbers: |
DCS-69-22 |
First Posted: | September 18, 2023 Key Record Dates |
Last Update Posted: | November 18, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Clobetasol Halobetasol Tazarotene Anti-Inflammatory Agents |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Dermatologic Agents Keratolytic Agents Vasoconstrictor Agents |