Adult patients diagnosed with mild to moderate psoriasis. Skin and Connective Tissue Diseases
Conditions
Interventions
The primary objective is to assess the clinical efficacy of the DE-AT0217 in relieving the symptomatology of mild to moderate psoriasis.
The investigational medical device will be administered to the
Visits:
Visit 1 (Day 0- Screening visit)
Visit 2- Day 15 (after 14 days of treatment)
Visit 3 - Day 29 (after 14 days of treatment)
Visit 4 – Day 43 (after 14 days from the end of the treatment)
Each
Sponsors
Devintec SAGL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult subjects 18 years or older 2. Subjects willing to sign the informed consent 3. Subjects previously diagnosed with mild to moderate plaque psoriasis 4. Subjects willing and able to comply with all clinic visits and study-related procedures
Exclusion criteria
Exclusion criteria: 1. Use of systemic and topical anti psoriatic therapy on the areas within 2 weeks prior to the beginning of the study 2. Concomitant use of systemic anti psoriatic therapy (e.g. methotrexate, biologics, phototherapy) 3. Concomitant use of topical corticotherapy 3. Any dermatological disease that might interfere psoriasis clinical evaluation or bring the subject in danger, or have other serious dermatological disease other than psoriasis 4. Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study. 5. Hypersensitivity or allergy to any of the IMP ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy is the primary measure. It will be evaluated from baseline to day 29 in terms of: 1. Erythema, Induration/Thickness, Scaling measured using PASI50 2. How much the skin problem has affected patient's life over the last week measured using the Dermatology Life Quality Index (DLQI) 3. Degree of erythema, induration, scale, averaged over the entire body measured using the sPGA 4. Itch measured using VAS on a scale of "no itch" (left) to "worst imaginable itch" (right) The criteria for efficacy evaluation will be the comparison of symptomatology reduction based, on clinical observations (PASI, DLQI, PGI and VAS scores), between baseline and 4th Visit. The criteria for safety evaluation will be the frequency of AEs occurrence, the number of drop-outs due to side effects and the disease progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety measured using patient records throughout the study: 1. Percentage of participants who experienced an AE 2. Number of drop-out due to side effects 3. Disease progression | — |
Countries
Romania
Outcome results
None listed