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NCT Number: NCT07839455

Oral and Topical Phytocannabinoids for Psoriasis

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Psoriasis Vulgaris Chemically-Induced Disorders Inflammation Marijuana Abuse Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Federal University of Latin American Integration

Foz do Iguaçu, Paraná, 85870-650, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • 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)

Treatment and study plan

Oral Cannabis Extract

Drug

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.

Other names: Full-Spectrum Cannabis Extract

Topical cannabis cream

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Dermatology Life Quality Index (DLQI) total score

    Time frame: Baseline and 6 months

    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.

  2. Beck Anxiety Inventory (BAI) total score

    Time frame: Baseline and 6 months

    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.

  3. Beck Depression Inventory (BDI-II) total score

    Time frame: Baseline and 6 months

    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.

  4. UKU Side Effect Rating Scale total score

    Time frame: Baseline and 6 months

    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

  5. Psoriasis Disability Index (PDI) total score

    Time frame: Baseline and 6 months

    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.

  6. Visual Analog Scale (VAS) score

    Time frame: Baseline and 6 months

    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.

  7. Perceived Stress Scale (PSS) total score

    Time frame: Baseline and 6 months

    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.

  8. Topical Cream Overall Acceptability Score

    Time frame: Baseline and 6 months

    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.

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

Federal University of Latin American Integration

Other

Collaborators

  • Associação Brasileira de Cannabis Medicinal

Registry information

Official study title

Oral and Topical Use of Phytocannabinoids for Patients With Psoriasis Vulgaris: An Open-Label Prospective Study - CBDermis

Acronym: CBDermis

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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