Evaluation of Dermasectan® versus SoC to compare efficacy and safety in treating atopic eczema (dermatitis) in adults
| ISRCTN | ISRCTN66879853 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66879853 |
| EudraCT/CTIS number | 2019-001729-28 |
| Secondary identifying numbers | CBSNOV2301 |
- Submission date
- 16/11/2021
- Registration date
- 24/11/2021
- Last edited
- 11/08/2023
- 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
Atopic dermatitis (AD) is a long-term disease, that often appears during early childhood and often before the age of two. It is estimated that about 10% of patients continue to suffer from eczema as adults. It has been shown in recent studies that the disease is more likely to occur in women and during the third decade of life and is prevalently localized in the limb flexures, eyelids, and perioral region, but also forehead, cheeks, anterolateral region of the neck. The diagnosis of AD is based on the following constellation of clinical findings: pruritus, facial and extensor eczema in infants and children, flexural eczema in adults, and chronicity of dermatitis.
Atopic dermatitis in adults is often a serious condition, so the diagnosis must be precise. If the disease dates back to childhood, and/or is combined with atopic respiratory symptoms (allergic rhinitis, allergic dermatitis, and asthma), and/or even digestive allergies, and there are typical clinical signs, like chronic thick, lichenified eczema, with oozing flare-ups; the diagnosis can be considered definitive. Besides childhood persistence, another cause for atopic dermatitis in adults can be a relapse by a modification of the environment (stress, cutaneous irritation, contact allergy). These patients show increased serum IgE levels (>150kU/L).
The aim of the study is to assess the clinical efficacy of Dermasectan® in alleviating the symptomatology of Atopic Dermatitis.
Who can participate?
Adult subjects, 18 years or older with AD diagnosed at screening visit.
What does the study involve?
The study lasted for 28 days, with two applications/day for 14 consecutive days of treatment with one of the study products: Dermasectan® or Placebo (depending on randomization arm).
What are the possible benefits and risks of participating?
This treatment could be very useful for you in treating atopic dermatitis by reducing the symptoms associated with this diagnosis. Even if there are no benefits for you, the results of this study could help in discovering new treatments for atopic dermatitis.
Your participation in this study is voluntary.
If by following the treatment plan, no results are obtained, your doctor will decide whether or not you should continue the treatment.
There is no information regarding risks or inconveniences.
Where is the study run from?
Novintethical Pharma SA (Switzerland)
When is the study starting and how long is it expected to run for?
June 2019 to May 2020
Who is funding the study?
Novintethical Pharma SA (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 | Double blind placebo-controlled randomized multicenter study |
|---|---|
| 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 randomized, double-blind, placebo-controlled, multicenter clinical trial investigating the efficacy and safety of Dermasectan® vs. placebo administered to adult patients with atopic dermatitis (AD) |
| Study acronym | CONTROL |
| Study objectives | A double-blind, parallel, randomized, placebo-controlled, multicenter study for the evaluation of efficacy and safety of Dermasectan® vs placebo in patients diagnosed with atopic dermatitis. |
| Ethics approval(s) | 1. Approved 13/06/2019, National Committee of Bioethics for Medicine and Medical Devices (Stefan Cel Mare 19-21 Road, District 2, Bucharest, Romania; +40 (0)212102880; comisia.bioetica@adsm.ro), ref: 2S/4/13.06.2019 2. Approved 17/02/2020, Ethics Committee for clinical trials (8 Damyan Gruev Str., Sofia 1303, Bulgaria; +359 (0)2 8903555; bda@bda.bg), ref: 01351/17.02.2020 |
| Health condition(s) or problem(s) studied | Atopic dermatitis |
| Intervention | The study subjects were randomly allocated to study arm based on a computer-generated sequence with 1:1 ratio: Dermasectan or Placebo. The subjects received for 14 consecutive days two applications/day on affected areas. The medication was provided by the Study Sponsor. Each patient received the necessary amount of product for 14 days at Baseline Visit. The investigator kept the product accountability during the entire duration of the study. All subjects included in the study were diagnosed, by their doctor, with atopic dermatitis. The study lasted for 28 days, with two applications/day for 14 consecutive days of treatment with one of the study products: Dermasectan or Placebo (depending on randomization arm). Participants attend four visits: - Visit 1 – day 0 (baseline visit) - Visit 2 – day 8 (after 7 days of treatment) - Visit 3 – day 15 (After 14 days of treatment) - Visit 4 – day 28 (14 days after end of treatment) follow-up by phone |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dermasectan® |
| Primary outcome measure | 1. Erythema, pruritus, exudation, excoriation, crusted erosions and lichenification are measured using a 4-point (0-3) scale - Atopic Dermatitis Severity Index (ADSI) - recorded at visits from: day 0, day 8, day 15. 2. Redness, swelling, oozing/crusting, scratch marks, skin thickening (lichenification), dryness are measured using SCORAD (Score Atopic Dermatitis) Calculator at the doctor’s office at the time of the visits at day 0, day 8, day 15; 3. Patient chart assessment by PATIENT ORIENTED ECZEMA MEASURE (POEM)– recorded at visits from: day 0, day 8, day 15. |
| Secondary outcome measures | The safety outcomes (percentage of participants who experienced an AE, number of drop-out due to side effects, disease progression) were evaluated during study visit at Day 8, Day 15 and Day 28. |
| Overall study start date | 13/06/2019 |
| Completion date | 02/05/2020 |
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. Subject willing to sign the informed consent 3. AD diagnosed at screening visit 4. Clinical digital photography to provide images of affected and healthy skin 5. Willing and able to comply with all clinic visits and study-related criteria |
| Key exclusion criteria | 1. The following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) during the first 4 weeks of study treatment: 1.1 Systemic corticosteroids 1.2 Immunosuppressive/immunomodulating drugs 1.3 Phototherapy for AD 2. Treatment with certain biologics 3. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit 4. Planned major surgical procedure during the patient's participation in this study 5. Patient is a member of the investigational team or his/her immediate family 6. Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study 7. Hypersensitivity to any of the ingredients of the study agents. |
| Date of first enrolment | 13/09/2019 |
| Date of final enrolment | 04/04/2020 |
Locations
Countries of recruitment
- Bulgaria
- Romania
Study participating centres
Constanta
900591
Romania
Bucharest
011461
Romania
Targu Mures
540072
Romania
Sofia
1700
Bulgaria
Plovdiv
4000
Bulgaria
Ruse
7000
Bulgaria
Sponsor information
Industry
Via Pian Scairolo, 11
Lugano
6900
Switzerland
| Phone | +41 91 234 15 72 |
|---|---|
| info@novintethical.com | |
| Website | http://www.novintethical.com/ |
"ROR" |
https://ror.org/05ypvb778 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 15/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. Additional documents will be provided at a later point. |
| IPD sharing plan | The data will be collected under 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 current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/07/2023 | 11/08/2023 | Yes | No |
Editorial Notes
11/08/2023: Publication reference added.
24/11/2021: Trial's existence confirmed by National Committee of Bioethics for Medicine and Medical Devices (Romania).
