Scalp PsoriasisPhase 4NCT05872256
A Demonstration of the Hair and Scalp Benefits of Duobrii in Scalp Psoriasis
A Phase 4 study testing 0.045% Tazarotene/0.01% Halobetasol Lotion in people with Scalp Psoriasis, run by Dermatology Consulting Services, PLLC at 1 site in United States.
Trial summary
The objectives of this research are to demonstrate the following:1. To demonstrate improvement in hair growth and hair appearance following 12 weeks of once daily treatment with tazarotene/halobetasol lotion in patients with moderate to severe scalp psoriasis.2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scalp Psoriasis
- What is being tested?
- 0.045% Tazarotene/0.01% Halobetasol Lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 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
- 1. Males or non-pregnant females 18+ years of age. 2. Plaque type moderate to severe scalp psoriasis suitable for topical treatment.
- 3. Subjects must be in general good health as determined from a medical history.
- 4. Subjects must read and sign the informed consent form after the nature of the study has been fully explained.
Who cannot join
- 1. Subjects with known allergies or sensitivities to ingredients contained in the test products.
- 2. Subjects with pustular or erythrodermic psoriasis. 3. Subjects who are pregnant or nursing or planning to become pregnant during the course of the study.
- 4. Subjects who are currently participating in any other clinical study (i.e., dermal patch, use tests, investigational drug or devices, etc.).
- 5. Subjects viewed by the investigator as not being able to complete the study. 6. Subjects using any type of lotion, medication, or other topical product to the scalp psoriasis within 2 weeks of study entry.
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 Hair and Scalp Benefits of 0.045% Tazarotene/0.01% Halobetasol Lotion in Scalp Psoriasis
The objectives of this research are to demonstrate the following:1. To demonstrate improvement in hair growth and hair appearance following 12 weeks of once daily treatment with tazarotene/halobetasol lotion in patients with moderate to severe scalp psoriasis.2. To demonstrate improvement in scalp itch reduction following 12 weeks of once daily treatment with tazarotene/halobetasol lotion in patients with moderate to severe scalp psoriasis.3. To pictorially demonstrate improvement in moderate to severe scalp psoriasis with 12 weeks of once daily treatment with tazarotene/halobetasol lotion.4. To assessment patient perceptions of the value of a lotion in the treatment of moderate to severe scalp psoriasis.
Read the detailed description
Male or female subjects with moderate to severe scalp 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 hair and no topical products applied to the scalp. If found to be suitable by meeting all inclusion criteria and none of the exclusion criteria, subjects will undergo scalp psoriasis evaluation by the dermatologist investigator for erythema, scaling, and induration. The subjects will also assess each plaque for redness, thickness, and scaling. The subjects and the dermatologist will assess the hair for lack of hair shine, poor manageability, frizziness, poor hair color, poor hair growth, and damaged cuticle structure. The subjects will assess scalp itch. Finally, digital photography will be conducted of the scalp psoriasis.Each subject will be dispensed one tube of tazarotene/halobetasol lotion for application to scalp once daily. Subjects will be provided with a diary. 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 and for all return visits.Subjects will return to the research center at week 4 and week 8 and week 12 for the same assessments. At week 12, a consumer perception survey will also be administered. All diaries will be collected at week 12. Subjects will be allowed to keep any unused study product. Subjects will complete their study participation at week 12.
- Conditions
- Scalp Psoriasis
- Being tested
- 0.045% Tazarotene/0.01% Halobetasol Lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.045% Tazarotene/0.01% Halobetasol LotionDrug
Also called Duobrii Lotion
FDA approved drug for psoriasis treatment
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Other | 0.045% Tazarotene/0.01% Habetasol Lotion apply once daily at bedtime to the scalp afflicted with psoriasis Receives: Drug: 0.045% Tazarotene/0.01% Halobetasol Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair Growth
Improvement in hair growth due to scalp psoriasis treatment
Measured: 12 weeks
Scalp Itch
Reduction in scalp itch due to scalp psoriasis treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Jun 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 Scalp PsoriasisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will receive the currently marketed and FDA approved Duobrii lotion to the scalp for the treatment of scalp psoriasis.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermatology Consulting Services, PLLC
- Sponsor type
- Research network
- Collaborators
- Ortho Dermatologics
- Responsible party
- Sponsor
- Investigators
- Zoe D Draelos, MD, Principal investigator, Dermatology Consulting Services, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872256
- Sponsor's protocol ID
- DCS-165-22
- Status last verified
- Nov 2023
- First submitted
- 14 May 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: The data will not be shared.
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 Hair and Scalp Benefits of 0.045% Tazarotene/0.01% Halobetasol Lotion in Scalp Psoriasis
- ClinicalTrials.gov ID
- NCT05872256
- Acronym / sponsor ID
- DCS-165-22
- Conditions
- Scalp Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dermatology Consulting Services, PLLCResearch network
- Collaborators
- Ortho Dermatologics
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 24 May 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 objectives of this research are to demonstrate the following:1. To demonstrate improvement in hair growth and hair appearance following 12 weeks of once daily treatment with tazarotene/halobetasol lotion in patients with moderate to severe scalp psoriasis.2. To demonstrate improvement in scalp itch reduction following 12 weeks of once daily treatment with tazarotene/halobetasol lotion in patients with moderate to severe scalp psoriasis.3. To pictorially demonstrate improvement in moderate to severe scalp psoriasis with 12 weeks of once daily treatment with tazarotene/halobetasol lotion.4. To assessment patient perceptions of the value of a lotion in the treatment of moderate to severe scalp psoriasis.
Detailed description
Male or female subjects with moderate to severe scalp 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 hair and no topical products applied to the scalp. If found to be suitable by meeting all inclusion criteria and none of the exclusion criteria, subjects will undergo scalp psoriasis evaluation by the dermatologist investigator for erythema, scaling, and induration. The subjects will also assess each plaque for redness, thickness, and scaling. The subjects and the dermatologist will assess the hair for lack of hair shine, poor manageability, frizziness, poor hair color, poor hair growth, and damaged cuticle structure. The subjects will assess scalp itch. Finally, digital photography will be conducted of the scalp psoriasis.Each subject will be dispensed one tube of tazarotene/halobetasol lotion for application to scalp once daily. Subjects will be provided with a diary. 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 and for all return visits.Subjects will return to the research center at week 4 and week 8 and week 12 for the same assessments. At week 12, a consumer perception survey will also be administered. All diaries will be collected at week 12. Subjects will be allowed to keep any unused study product. Subjects will complete their study participation at week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will receive the currently marketed and FDA approved Duobrii lotion to the scalp for the treatment of scalp psoriasis.
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Other | Drug: 0.045% Tazarotene/0.01% Halobetasol Lotion0.045% Tazarotene/0.01% Habetasol Lotion apply once daily at bedtime to the scalp afflicted with psoriasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Males or non-pregnant females 18+ years of age. 2. Plaque type moderate to severe scalp psoriasis suitable for topical treatment.
- 3. Subjects must be in general good health as determined from a medical history.
- 4. Subjects must read and sign the informed consent form after the nature of the study has been fully explained.
Key exclusion criteria (4 listed)
- 1. Subjects with known allergies or sensitivities to ingredients contained in the test products.
- 2. Subjects with pustular or erythrodermic psoriasis. 3. Subjects who are pregnant or nursing or planning to become pregnant during the course of the study.
- 4. Subjects who are currently participating in any other clinical study (i.e., dermal patch, use tests, investigational drug or devices, etc.).
- 5. Subjects viewed by the investigator as not being able to complete the study. 6. Subjects using any type of lotion, medication, or other topical product to the scalp psoriasis within 2 weeks of study entry.
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 |
|---|---|---|
| 0.045% Tazarotene/0.01% Halobetasol LotionAlso: Duobrii LotionFDA approved drug for psoriasis treatment | Drug | Active Arm |
Primary outcome
Hair Growth
Time frame: 12 weeks
Improvement in hair growth due to scalp psoriasis treatment
Scalp Itch
Time frame: 12 weeks
Reduction in scalp itch due to scalp psoriasis treatment
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. The data will not be shared.
Related trials for Scalp Psoriasis
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet)
Plaque Psoriasis
RecruitingPhase 4
Immune Spatial Features of Guselkumab Cutaneous Response
Psoriasis of Scalp
Not yet recruitingObservational study
Real-World Study of Xeligekimab for Moderate to Severe Plaque Psoriasis(XP-Real)
Plaque Psoriasis, Psoriatic Arthritis
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.
Zoe D Draelos, MD principal investigator
Dermatology Consulting Services, PLLC
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 0.045% Tazarotene/0.01% Halobetasol Lotion in people with Scalp Psoriasis, 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 3 inclusion and 4 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?
Hair Growth (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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.