Psoriasis VulgarisPhase 4NCT06042647
Anti-Inflammatory Effects of 0.045% Tazarotene/0.01% Halobetasol Lotion in Psoriasis
A Phase 4 study testing 0.01% Halobetasol, 0.045% Tazarotene and 0.05% Clobetasol Propionate in people with Psoriasis Vulgaris, run by Dermatology Consulting Services, PLLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- 0.01% Halobetasol, 0.045% Tazarotene and 0.05% Clobetasol Propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2023to 13 Nov 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Consulting Services, PLLC
High Point, North Carolina, 27262
About this study
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
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.
Read the 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.
- Conditions
- Psoriasis Vulgaris
- Being tested
- 0.01% Halobetasol, 0.045% Tazarotene, 0.05% Clobetasol Propionate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.01% HalobetasolDrug
Drug to be applied at bedtime to designated target psoriasis plaque at bedtime.
0.045% TazaroteneDrug
Drug to be applied in combination with 0.01% Halobetasol to the designated psoriasis plaque at bedtime.
0.05% Clobetasol PropionateDrug
Drug to be applied to designated psoriatic plaque at bedtime.
| Study group | Role | What they receive |
|---|---|---|
| 0.01% Halobetasol and 0.045% Tazarotene Lotion | Active comparator | 0.01% Halobetasol and 0.045% Tazarotene Lotion (Duobrii)Applied to designated target plaque at bedtime. Receives: Drug: 0.01% Halobetasol; Drug: 0.045% Tazarotene |
| Clobetasol Propionate 0.05% Cream (generic) | Active comparator | Clobetasol Propionate 0.05% Cream (generic)Applied to designated target plaque at bedtime. Receives: Drug: 0.05% Clobetasol Propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of TNF-a and IL-17A in Psoriatic Plaques
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start13 Jul 2023
- Primary completion13 Nov 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermatology Consulting Services, PLLC
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042647
- Sponsor's protocol ID
- DCS-69-22
- Status last verified
- Nov 2023
- First submitted
- 6 Sep 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06042647
- Acronym / sponsor ID
- DCS-69-22
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dermatology Consulting Services, PLLCResearch network
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 0.01% Halobetasol and 0.045% Tazarotene Lotion | Active comparator | Drug: 0.01% Halobetasol, Drug: 0.045% Tazarotene0.01% Halobetasol and 0.045% Tazarotene Lotion (Duobrii)Applied to designated target plaque at bedtime. |
| Clobetasol Propionate 0.05% Cream (generic) | Active comparator | Drug: 0.05% Clobetasol PropionateClobetasol Propionate 0.05% Cream (generic)Applied to designated target plaque at bedtime. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.01% HalobetasolDrug to be applied at bedtime to designated target psoriasis plaque at bedtime. | Drug | 0.01% Halobetasol and 0.045% Tazarotene Lotion |
| 0.045% TazaroteneDrug to be applied in combination with 0.01% Halobetasol to the designated psoriasis plaque at bedtime. | Drug | 0.01% Halobetasol and 0.045% Tazarotene Lotion |
| 0.05% Clobetasol PropionateDrug to be applied to designated psoriatic plaque at bedtime. | Drug | Clobetasol Propionate 0.05% Cream (generic) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.01% Halobetasol, 0.045% Tazarotene and 0.05% Clobetasol Propionate in people with Psoriasis Vulgaris, run by Dermatology Consulting Services, PLLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of TNF-a and IL-17A in Psoriatic Plaques (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.