Atopic DermatitisNCT02716181
Efficacy of the "Атопик Soothing Cream" in Children With Mild to Moderate Atopic Dermatitis
A study testing "Атопик Soothing Cream" in people with Atopic Dermatitis, run by Avanta Trading Ltd. at 1 site in Russia.
Trial summary
A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the "Атопик Soothing Cream" in Children with Mild to Moderate Atopic Dermatitis Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- "Атопик Soothing Cream"
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteRussia
- Study dates
- 29 Dec 2016to 1 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Must have clinical diagnosis of mild to moderate atopic dermatitis (AD) at both Screening and Baseline Visits, defined as IGA score of 2 or 3 ( Rothe 1996) or EASI score between 2 and 21 (Leshem 2015)
- Must have AD affecting >5% total body surface area (TBSA) at Baseline
- History of AD for at least 3 months prior to Baseline
- Informed consent/assent in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline and applicable regulations, before completing any study-related procedures
Who cannot join
- Use of topical corticosteroids within 7 days prior to Baseline
- Use of systemic corticosteroids, topical calcineurin inhibitors, photo-therapy (PUVA, UVB) or immunosuppressive therapy (eg, cyclosporine) within 14 days prior to Baseline
- Subjects that require systemic therapy for the treatment of AD
- Use of systemic anti-infective or antibiotic treatment within 14 days prior to Baseline
- Subjects who present with clinical conditions other than AD that may interfere with the evaluation (eg, generalized erythroderma, acne, Netherton's Syndrome, psoriasis)
- Any clinically significant skin disease other than AD
Show all 14Show fewer
- Secondary infection of AD (bacterial, viral or fungal) within the skin area under study or open skin infections in any area at Baseline
- History of severe anxiety and/or depression; any history of suicide attempt
- Subjects with a history of human immunodeficiency virus (HIV) as determined by medical history
- Subjects who, in the opinion of the Investigator(s), would be non-compliant with the visit schedule or study procedures
- Participation in any other investigational trial within 6 weeks of Baseline, or during study conduct
- Chronic condition(s) which are either unstable or not adequately controlled
- Drug or alcohol abuse, mental dysfunction, or other condition limiting the subject's ability to be compliant with study-related procedures
- Any medical condition that may, in the opinion of the Investigator(s), preclude the safe administration of test article or safe participation in the study
Trial locations and contacts
1 site in 1 country.
Russia1 site
Pediatric Allergy-Immunology, Department of Pediatrics, Institute of Professional Education
Samara
About this study
Official title: A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the "Атопик Soothing Cream" in Children With Mild to Moderate Atopic Dermatitis
A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the "Атопик Soothing Cream" in Children with Mild to Moderate Atopic Dermatitis
Read the detailed description
"Атопик Soothing Cream" is a lipid complex composed of barley grain, Butyrospermum Parkii and Argania Spinosa Kernel oil, in a mixture with panthenol and bisabolol.
Investigators concure that combination of these substances in "Атопик Soothing Cream" will be efficacious non-steroidal treatment of Atopic Dermatiti ( AD).
- Conditions
- Atopic Dermatitis
- Being tested
- "Атопик Soothing Cream", Placebo
- Keywords
- Atopic Dermatitis, Topical therapy
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Атопик Soothing Cream"Device
Topical application of a study cream to involved skin areas twice a day.
PlaceboDevice
Topical application of a study placebo cream to involved skin areas twice a day.
| Study group | Role | What they receive |
|---|---|---|
| "Атопик" phase 1 | Active comparator | For the first phase of the study, subjects will be randomized to receive treatment with "Атопик Soothing Cream". Receives: Device: "Атопик Soothing Cream"; Device: Placebo |
| Placebo - phase 1 | Placebo comparator | For the first phase of the study, subjects will be randomized to receive treatment with Placebo Cream. Receives: Device: "Атопик Soothing Cream"; Device: Placebo |
| "Атопик" phase 2 | Active comparator | The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream". Receives: Device: "Атопик Soothing Cream"; Device: Placebo |
| Placebo - phase 2 | Placebo comparator | The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream". Receives: Device: "Атопик Soothing Cream"; Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigators' Global Assessment score
Measured: 28 days
Secondary outcomes (2)
Eczema Area & Severity Index (EASI)
Measured: 28 days
Pruritus intensity
Visual Analog Scale
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study start29 Dec 2016
- Primary completion1 May 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avanta Trading Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Samara State Medical University, Prof. Zvulunov Alex, Pediatric Dermatology Clinic, Kfar-Saba, Israel.
- Responsible party
- Sponsor
- Investigators
- Alex Zvulunov, MD, Study director, Prof. Alex Zvulunov, Pediatric Dermatology Clinic, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716181
- Sponsor's protocol ID
- 166-2015
- Status last verified
- Mar 2016
- First submitted
- 13 Mar 2016
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Clinical parameters at the entry and at the end of study might be shared.
Publications
Maurya AK, Singh M, Dubey V, Srivastava S, Luqman S, Bawankule DU. alpha-(-)-bisabolol reduces pro-inflammatory cytokine production and ameliorates skin inflammation. Curr Pharm Biotechnol. 2014;15(2):173-81. doi: 10.2174/1389201015666140528152946.
PubMed 24894548Ebner F, Heller A, Rippke F, Tausch I. Topical use of dexpanthenol in skin disorders. Am J Clin Dermatol. 2002;3(6):427-33. doi: 10.2165/00128071-200203060-00005.
PubMed 12113650Jirabundansuk P, Ophaswongse S, Udompataikul M. Comparative trial of moisturizer containing spent grain wax, Butyrospermum parkii extract, Argania spinosa kernel oil vs. 1% hydrocortisone cream in the treatment of childhood atopic dermatitis. J Med Assoc Thai. 2014 Aug;97(8):820-6.
PubMed 25345257
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the "Атопик Soothing Cream" in Children With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02716181
- Acronym / sponsor ID
- 166-2015
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Topical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Avanta Trading Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Samara State Medical University, Prof. Zvulunov Alex, Pediatric Dermatology Clinic, Kfar-Saba, Israel.
- Study start
- 29 Dec 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 23 Mar 2016 (estimated)
- 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.
A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the "Атопик Soothing Cream" in Children with Mild to Moderate Atopic Dermatitis
Detailed description
"Атопик Soothing Cream" is a lipid complex composed of barley grain, Butyrospermum Parkii and Argania Spinosa Kernel oil, in a mixture with panthenol and bisabolol.
Investigators concure that combination of these substances in "Атопик Soothing Cream" will be efficacious non-steroidal treatment of Atopic Dermatiti ( AD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| "Атопик" phase 1 | Active comparator | Device: "Атопик Soothing Cream", Device: PlaceboFor the first phase of the study, subjects will be randomized to receive treatment with "Атопик Soothing Cream". |
| Placebo - phase 1 | Placebo comparator | Device: "Атопик Soothing Cream", Device: PlaceboFor the first phase of the study, subjects will be randomized to receive treatment with Placebo Cream. |
| "Атопик" phase 2 | Active comparator | Device: "Атопик Soothing Cream", Device: PlaceboThe second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream". |
| Placebo - phase 2 | Placebo comparator | Device: "Атопик Soothing Cream", Device: PlaceboThe second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream". |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Must have clinical diagnosis of mild to moderate atopic dermatitis (AD) at both Screening and Baseline Visits, defined as IGA score of 2 or 3 ( Rothe 1996) or EASI score between 2 and 21 (Leshem 2015)
- Must have AD affecting >5% total body surface area (TBSA) at Baseline
- History of AD for at least 3 months prior to Baseline
- Informed consent/assent in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline and applicable regulations, before completing any study-related procedures
Key exclusion criteria (14 listed)
- Use of topical corticosteroids within 7 days prior to Baseline
- Use of systemic corticosteroids, topical calcineurin inhibitors, photo-therapy (PUVA, UVB) or immunosuppressive therapy (eg, cyclosporine) within 14 days prior to Baseline
- Subjects that require systemic therapy for the treatment of AD
- Use of systemic anti-infective or antibiotic treatment within 14 days prior to Baseline
- Subjects who present with clinical conditions other than AD that may interfere with the evaluation (eg, generalized erythroderma, acne, Netherton's Syndrome, psoriasis)
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 |
|---|---|---|
| "Атопик Soothing Cream"Topical application of a study cream to involved skin areas twice a day. | Device | "Атопик" phase 1, "Атопик" phase 2, Placebo - phase 1, Placebo - phase 2 |
| PlaceboTopical application of a study placebo cream to involved skin areas twice a day. | Device | "Атопик" phase 1, "Атопик" phase 2, Placebo - phase 1, Placebo - phase 2 |
Primary outcome
Investigators' Global Assessment score
Time frame: 28 days
2 secondary outcomes
Eczema Area & Severity Index (EASI)
Time frame: 28 days
Pruritus intensity
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Background: PubMed 24894548Maurya AK, Singh M, Dubey V, Srivastava S, Luqman S, Bawankule DU. alpha-(-)-bisabolol reduces pro-inflammatory cytokine production and ameliorates skin inflammation. Curr Pharm Biotechnol. 2014;15(2):173-81. doi: 10.2174/1389201015666140528152946.
- Background: PubMed 12113650Ebner F, Heller A, Rippke F, Tausch I. Topical use of dexpanthenol in skin disorders. Am J Clin Dermatol. 2002;3(6):427-33. doi: 10.2165/00128071-200203060-00005.
- Results publication: PubMed 25345257Jirabundansuk P, Ophaswongse S, Udompataikul M. Comparative trial of moisturizer containing spent grain wax, Butyrospermum parkii extract, Argania spinosa kernel oil vs. 1% hydrocortisone cream in the treatment of childhood atopic dermatitis. J Med Assoc Thai. 2014 Aug;97(8):820-6.
- Individual participant dataSharing planned: Yes. Clinical parameters at the entry and at the end of study might be shared.
Related trials for Atopic Dermatitis
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First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
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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.
Alex Zvulunov, MD study director
Prof. Alex Zvulunov, Pediatric Dermatology Clinic, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Атопик Soothing Cream" in people with Atopic Dermatitis, run by Avanta Trading Ltd. at 1 site in Russia.
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 4 inclusion and 14 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: finished, as of the sponsor's last update on 11 Jan 2018. 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 Russia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Investigators' Global Assessment score (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02716181, which also lists 3 linked publications.
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 11 Jan 2018.