A Demonstration of the Hair and Scalp Benefits of Duobrii in Scalp Psoriasis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Dermatology Consulting Services, PLLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Zoe D Draelos, MD
Principal Investigator Affiliation Dermatology Consulting Services, PLLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Scalp Psoriasis
Additional Details

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.

Arms & Interventions


Other: Active Arm

0.045% Tazarotene/0.01% Habetasol Lotion apply once daily at bedtime to the scalp afflicted with psoriasis


Drug: - 0.045% Tazarotene/0.01% Halobetasol Lotion

FDA approved drug for psoriasis treatment

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dermatology Consulting Services, PLLC, High Point, North Carolina




Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262

Site Contact

Zoe D Draelos, MD



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