Evaluation of DEAT0217 versus standard of care to compare effectiveness and safety in treating moderate psoriasis in adult patients
| ISRCTN | ISRCTN28479470 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28479470 |
| Secondary identifying numbers | CEBDEV-04032020 |
- Submission date
- 25/11/2021
- Registration date
- 16/12/2021
- Last edited
- 26/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and Study Aims
Psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. These patches normally appear on your elbows, knees, scalp, and lower back, but can appear anywhere on your body. Most people are only affected with small patches. In some cases, the patches can be itchy or sore.
This is a prospective, multicenter, open-label study for evaluation of efficacy and safety of a new device (DEAT0217) versus the standard of care (e.g calcipotriol) in adult patients diagnosed with mild to moderate psoriasis.
Who can participate?
Adult subjects 18 years or older diagnosed with mild to moderate plaque psoriasis.
What does the study involve?
Participants will be randomly allocated to receive DEAT0217 applied twice a day for 4 weeks, or the standard of care.
What are the possible benefits and risks of participating?
Benefits:
This treatment could be very useful for you in the treatment of mild to moderate psoriasis, by reducing the symptoms associated with this diagnosis and improving the quality of life. Study treatment may bring you personal benefits, or it may not. Even if there are no benefits for you, the results of this study could help discover new treatments that reduce the symptoms of this condition.
Your participation in this study is voluntary.
If, according to the treatment plan, the expected results are not obtained, your doctor will decide whether or not to continue the treatment.
Risks:
You are not required to participate in this study, and your study doctor will tell you about other treatments and their risks and benefits. The treatment strategy for your condition will be recommended to you by your doctor. Thus, your doctor may prescribe an alternative to study treatment.
Where is the study run from?
Devintec SAGL (Switzerland)
When is the study starting and how long is it expected to run for?
May 2020 to November 2020
Who is funding the study?
Devintec SAGL, Lugano, Switzerland
Who is the main contact?
Alina Iordache
alina.iordache@cebis-int.com
Contact information
Scientific
222 Calea Plevnei 3rd Floor
Bucharest
060016
Romania
 ORCID ID |
0000-0002-5931-0463 |
|---|---|
| Phone | +40 737 640 721 |
| alina.iordache@cebis-int.com |
Study information
| Study design | Interventional multi center open label randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | A prospective, multicenter, open-label study to evaluate the safety and efficacy of DE-AT0217 versus standard of care (e.g. calcipotriol) in adult patients diagnosed with mild to moderate psoriasis |
| Study acronym | CLEAR Study |
| Study objectives | This is a prospective, multicenter, open-label study for evaluation of efficacy and safety of DEAT0217 versus standard of care (e.g calcipotriol) in adult patients diagnosed with mild to moderate psoriasis. |
| Ethics approval(s) | Approved 06/05/2020, National Committee of Medical Bioethics for clinical trials (Stefan Cel Mare 19-21 Road, District 2, Bucharest, Romania; +40 (0)212102880; comisia.bioetica@adsm.ro.), ref: CPMP/ICH/135/95; ICH Topic E6 |
| Health condition(s) or problem(s) studied | Adult patients diagnosed with mild to moderate psoriasis. |
| Intervention | 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 subjects who meet the eligibility criteria and give their informed consent to participate in the study. The treatment with DE-AT0217 will be administered by topical route, according to the approved leaflet. The treatment will be administered according to the approved leaflet for 29 consecutive days; 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 investigator was asked to enroll the subjects in a 1:1 ratio to avoid systematic errors that could occur during group assignment or due to subjectivity. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | DE-AT0217 |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 06/05/2020 |
| Completion date | 11/11/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 42 |
| Total final enrolment | 42 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 24/06/2020 |
| Date of final enrolment | 28/09/2020 |
Locations
Countries of recruitment
- Romania
Study participating centres
Targoviste
130095
Romania
Cluj
400000
Romania
Bucharest
020125
Romania
Sponsor information
Industry
Corso Elvezia 14
Lugano
6900
Switzerland
| Phone | +41 91 601 40 51 |
|---|---|
| info@devintecpharma.com | |
| Website | https://devintecpharma.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 11/11/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results obtained from this study are property of the Sponsor. In case of publication, the Investigators will be informed and will be free to cooperate as Authors. |
| IPD sharing plan | The data will be collected under the study confidentiality and for the study purpose only, according to the approved informed consent form. The study data will be archived according to the sponsor requirements and local regulatory requirements. The datasets generated during and/or analysed during the current study are available from the corresponding authors on reasonable request: Rosca Valentina, Emergency County Hospital Orasan Remus. Individual Medical Office of Dermatology Prof. Dr. Orasan Remus Ioan Magda Constantin, Colentina Clinical Hospital |
Editorial Notes
26/11/2021: Trial's existence confirmed by National Committee of Medical Bioethics for clinical trials.
