Psoriasis VulgarisPhase 2CBDermisNCT07839455
Oral and Topical Phytocannabinoids for Psoriasis
A Phase 2 study testing Oral Cannabis Extract and Topical cannabis cream in people with Psoriasis Vulgaris, run by Federal University of Latin American Integration at 1 site in Brazil.
Trial summary
Psoriasis is a chronic inflammatory skin disease that affects approximately 2% of the global population and is frequently associated with psychiatric comorbidities such as anxiety and depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Oral Cannabis Extract and Topical cannabis cream
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2025to Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of psoriasis vulgaris confirmed by a dermatologist
- Age between 18 and 65 years
- Psoriasis Area and Severity Index (PASI) ≤ 10 at screening
- Patients with clinical stability over the past 3 months, without significant changes in psoriasis condition
- Availability to attend consultations and periodic assessments during the study
- Agreement to participate and signing of the Informed Consent Form (ICF)
Who cannot join
- Patients who do not meet the inclusion criteria
- Presence of other active inflammatory dermatological diseases that may interfere with psoriasis assessment
- History of severe recurrent skin infections or active infection at screening
- History of psychosis or first-degree family history of schizophrenia or epilepsy
- Severe cardiovascular diseases
- Severe hepatic or renal diseases
Show all 12Show fewer
- Use of phototherapy within the last 2 months
- Pregnant or breastfeeding women
- Diagnosis of psoriatic arthritis
- Lack of availability to attend study assessments
- Ongoing pharmacological treatment with unstable therapy or changes in lesion severity within the last 30 days
- Refusal to sign the Informed Consent Form (ICF)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Latin American Integration
Foz do Iguaçu, Paraná, 85870-650
About this study
Official title: Oral and Topical Use of Phytocannabinoids for Patients With Psoriasis Vulgaris: An Open-Label Prospective Study - CBDermis
Psoriasis is a chronic inflammatory skin disease that affects approximately 2% of the global population and is frequently associated with psychiatric comorbidities such as anxiety and depression. Although conventional treatments, including topical corticosteroids and biologic agents, may be effective, many patients face challenges related to treatment adherence, adverse effects, and the psychosocial impact of the disease. This open label study aims to investigate the efficacy and acceptability of medicinal cannabis formulations administered orally and topically in the management of mild to moderate psoriasis. 37 participants will be included and will use full spectrum cannabis formulations in the (1:1:1) CBD:CBG:THC ratio at a concentration of 20 mg/ml. The protocol will have a total duration of 180 days, consisting of 60 days of isolated treatment followed by 120 days of combined treatment. Efficacy will be assessed using validated instruments, including PASI, DLQI, BDI II and BAI, the Visual Analog Scale for pruritus intensity, the Cosmetic Acceptability Scale, and the Treatment Satisfaction Scale. The use of cannabis formulations is expected to promote clinical improvement of skin lesions, reduction of subjective symptoms such as pruritus and discomfort, and a positive impact on patients quality of life. This study seeks to contribute to the generation of evidence, regarding the efficacy, safety, and acceptability of therapeutic cannabis use in the dermatological context.
Read the detailed description
This study aims to evaluate the effects of oral and topical cannabinoid administration in patients with psoriasis over a 180-day period.
Oral administration will be performed using a full-spectrum extract containing CBD:CBG:THC in a 1:1:1 ratio, with a concentration of 20 mg/mL of each cannabinoid. Dose titration will be conducted progressively according to individual tolerability. The dosing schedule will follow a stepwise escalation: 0.08 mL/day in the first week (approximately 1.6 mg/day of each cannabinoid), 0.17 mL/day in the second week (approximately 3.3 mg/day of each cannabinoid), and 0.25 mL/day in the third week (5 mg/day of each cannabinoid). From the second month onward, the dose will be increased to 0.5 mL/day (10 mg/day of each cannabinoid), defined as the maximum study dose, and maintained until the end of the intervention period.
Topical administration will be performed using a cream containing CBD:CBG:THC, in the same proportion as the oral extract, with a concentration of 20 mg/mL of each cannabinoid. The product will be applied directly to psoriasis lesions twice daily throughout the study period. No titration will be performed for the topical formulation, and a fixed-dose regimen will be maintained.
The study will follow a two-phase design. Participants will be initially allocated into two groups: Group 1 (oral) will receive the oral extract for the first 60 days, while Group 2 (topical) will use the topical formulation during the same period. In the second phase (days 60-180), all participants will receive combined treatment (oral extract plus topical formulation). This design allows evaluation of both isolated and combined therapeutic effects.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Oral Cannabis Extract, Topical cannabis cream
- Keywords
- psoriasis, cannabis, CBD, inflammation, skin
- Medical subject headings
- Psoriasis, Marijuana Abuse, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Cannabis ExtractDrug
Also called Full-Spectrum Cannabis Extract
Oral administration of a full-spectrum cannabis extract containing CBD, CBG, and THC in a 1:1:1 ratio, with a concentration of 20 mg/mL of each cannabinoid. Dose titration will be performed progressively according to tolerability, followed by maintenance at the maximum dose.
Topical cannabis creamDrug
Topical formulation containing CBD, CBG, and THC in a 1:1:1 ratio (20 mg/mL each), applied directly to psoriatic lesions twice daily throughout the study period. No dose titration will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Oral Cannabis Extract | Experimental | Participants assigned to this arm will receive an oral full-spectrum cannabis extract containing cannabidiol (CBD), cannabigerol (CBG), and delta-9-tetrahydrocannabinol (THC) in a 1:1:1 ratio, with a concentration of 20 mg/mL of each cannabinoid.
During the first 60 days, oral administration will follow a progressive dose titration based on individual tolerability:
Week 1: 0.08 mL/day (≈1.6 mg/day of each cannabinoid) Week 2: 0.17 mL/day (≈3.3 mg/day of each cannabinoid) Week 3: 0.25 mL/day (5 mg/day of each cannabinoid) From Day 30 onward: 0.5 mL/day (10 mg/day of each cannabinoid), maintained as the maximum study dose
From Day 61 to Day 180, participants will receive combined therapy consisting of oral cannabis extract plus topical cannabis cream applied to psoriatic lesions. Receives: Drug: Oral Cannabis Extract; Drug: Topical cannabis cream |
| Topical Cannabis Cream | Experimental | Participants assigned to this arm will apply a topical full-spectrum cannabis cream containing cannabidiol (CBD), cannabigerol (CBG), and delta-9-tetrahydrocannabinol (THC) in a 1:1:1 ratio, with a concentration of 20 mg/mL of each cannabinoid.
During the first 60 days, the cream will be applied directly to psoriatic lesions twice daily, with a fixed-dose regimen and no titration.
From Day 61 to Day 180, participants will receive combined therapy consisting of topical cannabis cream plus oral cannabis extract administered with progressive dose titration as described Receives: Drug: Oral Cannabis Extract; Drug: Topical cannabis cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index (PASI) total score
Single aggregated composite score evaluating overall psoriasis severity across four body regions (head, trunk, upper limbs, and lower limbs) and three lesion characteristics (erythema, induration, and desquamation). Individual parameters and sub-scores are combined via the standard PASI mathematical formula to yield a single reported outcome value ranging from 0 to 72, where higher scores represent greater overall disease severity.
Measured: Baseline and 6 months
Secondary outcomes (8)
Dermatology Life Quality Index (DLQI) total score
Single aggregated score evaluating health-related quality of life using the 10-item DLQI questionnaire. Items covering symptoms, daily activities, leisure, work/school, personal relationships, and treatment (each scored 0 to 3) are summed to arrive at one reported outcome value ranging from 0 to 30, where higher scores reflect poorer quality of life.
Measured: Baseline and 6 months
Beck Anxiety Inventory (BAI) total score
Single aggregated score evaluating anxiety symptom severity over the past two weeks using the 21-item BAI questionnaire. Individual item scores (ranging from 0 to 3) are summed to arrive at one reported outcome value ranging from 0 to 63, where higher total scores indicate greater severity of anxiety.
Measured: Baseline and 6 months
Beck Depression Inventory (BDI-II) total score
Single aggregated score evaluating the severity of depressive symptoms over the past two weeks using the 21-item BDI-II questionnaire. Participant responses to each item (scored 0 to 3) are summed to arrive at one reported outcome value ranging from 0 to 63, where higher total scores indicate greater severity of depressive symptoms.
Measured: Baseline and 6 months
UKU Side Effect Rating Scale total score
Single aggregated score evaluating the cumulative burden of adverse effects using the UKU Side Effect Rating Scale. Individual item scores across evaluated domains (each scored 0 = none to 3 = severe) are summed to arrive at one reported outcome value, where higher total scores indicate a greater overall severity and frequency of adverse effects
Measured: Baseline and 6 months
Psoriasis Disability Index (PDI) total score
Single aggregated score evaluating functional disability caused by psoriasis using the 15-item PDI questionnaire. Individual item scores across daily activities, leisure, work/school, and personal relationships (each scored 0 to 3) are summed to arrive at one reported outcome value ranging from 0 to 45, where higher total scores indicate a greater degree of functional disability.
Measured: Baseline and 6 months
Visual Analog Scale (VAS) score
Single continuous score evaluating pruritus (itching) intensity over the preceding period using a 10 cm Visual Analog Scale (VAS). Participants mark a point on a horizontal line ranging from 0 cm ("no itching") to 10 cm ("unbearable itching"). The outcome reported is the measured distance along the line in centimeters, where higher values represent greater pruritus severity.
Measured: Baseline and 6 months
Perceived Stress Scale (PSS) total score
Single aggregated score evaluating the degree to which life situations are perceived as stressful using the 14-item PSS-14 questionnaire. After reverse-scoring positive items, all individual 5-point Likert scale items (scored 0 = never to 4 = always) are summed to arrive at one reported outcome value ranging from 0 to 56, where higher total scores indicate greater overall perceived stress.
Measured: Baseline and 6 months
Topical Cream Overall Acceptability Score
Single aggregated score evaluating participant satisfaction and sensory characteristics (texture, spreadability, absorption, residual oiliness, odor, and skin feel) of the topical cream. Participant ratings across all 5-point Likert items (ranging from 1 = "very unpleasant" to 5 = "very pleasant") are averaged to yield a single reported outcome value, where higher scores represent greater product acceptability.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Nov 2025
- Primary completion1 Oct 2026 (estimated)
- Study completionFeb 2027 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Latin American Integration
- Sponsor type
- University, hospital or other
- Collaborators
- Associação Brasileira de Cannabis Medicinal
- Responsible party
- Sponsor
- Investigators
- Francisney p Nascimento, Study director, Federal University of Latin American Integration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839455
- Sponsor's protocol ID
- CBDermis-001
- Other IDs
- 89279925.6.0000.0107
- Acronym
- CBDermis
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral and Topical Use of Phytocannabinoids for Patients With Psoriasis Vulgaris: An Open-Label Prospective Study - CBDermis
- ClinicalTrials.gov ID
- NCT07839455
- Acronym / sponsor ID
- CBDermis / CBDermis-001
- Conditions
- Psoriasis Vulgaris
- Keywords
- psoriasis, cannabis, CBD, inflammation, skin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Federal University of Latin American IntegrationUniversity, hospital or other
- Collaborators
- Associação Brasileira de Cannabis Medicinal
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 24 Sep 2026 (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.
Psoriasis is a chronic inflammatory skin disease that affects approximately 2% of the global population and is frequently associated with psychiatric comorbidities such as anxiety and depression. Although conventional treatments, including topical corticosteroids and biologic agents, may be effective, many patients face challenges related to treatment adherence, adverse effects, and the psychosocial impact of the disease. This open label study aims to investigate the efficacy and acceptability of medicinal cannabis formulations administered orally and topically in the management of mild to moderate psoriasis. 37 participants will be included and will use full spectrum cannabis formulations in the (1:1:1) CBD:CBG:THC ratio at a concentration of 20 mg/ml. The protocol will have a total duration of 180 days, consisting of 60 days of isolated treatment followed by 120 days of combined treatment. Efficacy will be assessed using validated instruments, including PASI, DLQI, BDI II and BAI, the Visual Analog Scale for pruritus intensity, the Cosmetic Acceptability Scale, and the Treatment Satisfaction Scale. The use of cannabis formulations is expected to promote clinical improvement of skin lesions, reduction of subjective symptoms such as pruritus and discomfort, and a positive impact on patients quality of life. This study seeks to contribute to the generation of evidence, regarding the efficacy, safety, and acceptability of therapeutic cannabis use in the dermatological context.
Detailed description
This study aims to evaluate the effects of oral and topical cannabinoid administration in patients with psoriasis over a 180-day period.
Oral administration will be performed using a full-spectrum extract containing CBD:CBG:THC in a 1:1:1 ratio, with a concentration of 20 mg/mL of each cannabinoid. Dose titration will be conducted progressively according to individual tolerability. The dosing schedule will follow a stepwise escalation: 0.08 mL/day in the first week (approximately 1.6 mg/day of each cannabinoid), 0.17 mL/day in the second week (approximately 3.3 mg/day of each cannabinoid), and 0.25 mL/day in the third week (5 mg/day of each cannabinoid). From the second month onward, the dose will be increased to 0.5 mL/day (10 mg/day of each cannabinoid), defined as the maximum study dose, and maintained until the end of the intervention period.
Topical administration will be performed using a cream containing CBD:CBG:THC, in the same proportion as the oral extract, with a concentration of 20 mg/mL of each cannabinoid. The product will be applied directly to psoriasis lesions twice daily throughout the study period. No titration will be performed for the topical formulation, and a fixed-dose regimen will be maintained.
The study will follow a two-phase design. Participants will be initially allocated into two groups: Group 1 (oral) will receive the oral extract for the first 60 days, while Group 2 (topical) will use the topical formulation during the same period. In the second phase (days 60-180), all participants will receive combined treatment (oral extract plus topical formulation). This design allows evaluation of both isolated and combined therapeutic effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Cannabis Extract | Experimental | Drug: Oral Cannabis Extract, Drug: Topical cannabis creamParticipants assigned to this arm will receive an oral full-spectrum cannabis extract containing cannabidiol (CBD), cannabigerol (CBG), and delta-9-tetrahydrocannabinol (THC) in a 1:1:1 ratio, with a concentration of 20 mg/mL of each cannabinoid. During the first 60 days, oral administration will follow a progressive dose titration based on individual tolerability: Week 1: 0.08 mL/day (≈1.6 mg/day of each cannabinoid) Week 2: 0.17 mL/day (≈3.3 mg/day of each cannabinoid) Week 3: 0.25 mL/day (5 mg/day of each cannabinoid) From Day 30 onward: 0.5 mL/day (10 mg/day of each cannabinoid), maintained as the maximum study dose From Day 61 to Day 180, participants will receive combined therapy consisting of oral cannabis extract plus topical cannabis cream applied to psoriatic lesions. |
| Topical Cannabis Cream | Experimental | Drug: Oral Cannabis Extract, Drug: Topical cannabis creamParticipants assigned to this arm will apply a topical full-spectrum cannabis cream containing cannabidiol (CBD), cannabigerol (CBG), and delta-9-tetrahydrocannabinol (THC) in a 1:1:1 ratio, with a concentration of 20 mg/mL of each cannabinoid. During the first 60 days, the cream will be applied directly to psoriatic lesions twice daily, with a fixed-dose regimen and no titration. From Day 61 to Day 180, participants will receive combined therapy consisting of topical cannabis cream plus oral cannabis extract administered with progressive dose titration as described |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of psoriasis vulgaris confirmed by a dermatologist
- Age between 18 and 65 years
- Psoriasis Area and Severity Index (PASI) ≤ 10 at screening
- Patients with clinical stability over the past 3 months, without significant changes in psoriasis condition
- Availability to attend consultations and periodic assessments during the study
Key exclusion criteria (12 listed)
- Patients who do not meet the inclusion criteria
- Presence of other active inflammatory dermatological diseases that may interfere with psoriasis assessment
- History of severe recurrent skin infections or active infection at screening
- History of psychosis or first-degree family history of schizophrenia or epilepsy
- Severe cardiovascular diseases
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 |
|---|---|---|
| Oral Cannabis ExtractAlso: Full-Spectrum Cannabis ExtractOral administration of a full-spectrum cannabis extract containing CBD, CBG, and THC in a 1:1:1 ratio, with a concentration of 20 mg/mL of each cannabinoid. Dose titration will be performed progressively according to tolerability, followed by maintenance at the maximum dose. | Drug | Oral Cannabis Extract, Topical Cannabis Cream |
| Topical cannabis creamTopical formulation containing CBD, CBG, and THC in a 1:1:1 ratio (20 mg/mL each), applied directly to psoriatic lesions twice daily throughout the study period. No dose titration will be performed. | Drug | Oral Cannabis Extract, Topical Cannabis Cream |
Primary outcome
Psoriasis Area and Severity Index (PASI) total score
Time frame: Baseline and 6 months
Single aggregated composite score evaluating overall psoriasis severity across four body regions (head, trunk, upper limbs, and lower limbs) and three lesion characteristics (erythema, induration, and desquamation). Individual parameters and sub-scores are combined via the standard PASI mathematical formula to yield a single reported outcome value ranging from 0 to 72, where higher scores represent greater overall disease severity.
8 secondary outcomes
Dermatology Life Quality Index (DLQI) total score
Time frame: Baseline and 6 months
Beck Anxiety Inventory (BAI) total score
Time frame: Baseline and 6 months
Beck Depression Inventory (BDI-II) total score
Time frame: Baseline and 6 months
UKU Side Effect Rating Scale total score
Time frame: Baseline and 6 months
Psoriasis Disability Index (PDI) total score
Time frame: Baseline and 6 months
Visual Analog Scale (VAS) score
Time frame: Baseline and 6 months
Perceived Stress Scale (PSS) total score
Time frame: Baseline and 6 months
Topical Cream Overall Acceptability Score
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
Related trials for Psoriasis Vulgaris
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris
Not yet recruiting
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
Psoriasis, Psoriasis; Plaque
RecruitingPhase 1
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants
Psoriasis Vulgaris
RecruitingPhase 2
Shuiniujiao Dihuang Decoction With Variation for the Treatment of Psoriasis
Psoriasis Vulgaris
Not yet recruiting
A Randomised Controlled Trial of ePROM-Guided Flexible Scheduling in Dermatology
Chronic Dermatological Conditions, Eczema
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.
Francisney p Nascimento study director
Federal University of Latin American Integration
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Cannabis Extract and Topical cannabis cream in people with Psoriasis Vulgaris, run by Federal University of Latin American Integration at 1 site in Brazil.
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 12 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. 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 Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Psoriasis Area and Severity Index (PASI) total score (time frame: Baseline and 6 months). 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 24 Sep 2026.