Atopic DermatitisPhase 3NCT04018131
The Efficacy of Cimetidin for Acute - Extrinsic Atopic Dermatitis Treated With Standard Therapy
A Phase 3 study testing Cimetidine in people with Atopic Dermatitis and Immunoglobulin E Concentration, Serum, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
Trial summary
Extrinsic - atopic dermatitis is characterized by increased of IgE serum levels. Acute extrinsic - atopic dermatitis is a type 1 hypersensitivity that involve various inflammatory mediator including Interleukin-4, Interleukin-12, and Interferon-Ɣ. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Atopic Dermatitis, Immunoglobulin E Concentration, Serum
- What is being tested?
- Cimetidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteIndonesia
- Study dates
- 26 Mar 2018to 30 Jun 2020
- Phase
- Phase 3
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Atopic dermatitis patients diagnosed with Hanifin Rajka criteria
- Acute extrinsic atopic dermatitis
- IgE levels above 200 IU/mL
- Minimum weight 15kg
Who cannot join
- Consumption of corticosteroid and systemic immunosuppressant within the last 2 weeks
- Chronic lesion
- Consumption of drugs that reacts with cimetidine
- Disturbance in lab results including complete blood count, liver function, and renal function.
- Other conditions that might increase IgE levels
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Faculty of Medicine Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
Endi Novianto, MD, +628161309063, drendinovianto@gmail.com
About this study
Official title: The Efficacy of Cimetidin for Acute - Extrinsic Atopic Dermatitis Treated With Standard Therapy, a Study of Immunoglobulin E, Interleukin-4, Interleukin-12, and Interferon-Ɣ Serum Levels
Extrinsic - atopic dermatitis is characterized by increased of IgE serum levels. Acute extrinsic - atopic dermatitis is a type 1 hypersensitivity that involve various inflammatory mediator including Interleukin-4, Interleukin-12, and Interferon-Ɣ. Recent treatment of atopic dermatitis mainly focused on reducing the inflammation through topical and systemic regiments. However, no systemic medication could control the atopic dermatitis remission yet, and the current immunosuppressive agent used may cause many side effects if administered on a long term basis.
In the future, treatment of atopic dermatitis were specifically targeted to inhibit the role of Th2. Cimetidine is H2 receptor antihistamine that has been widely used as gastrointestinal medication for a long time. Cimetidine could modulate the immune system by activating the Th1 and lowering the Th2 activity, and lowering the IgE levels thus reducing the severity of atopic dermatitis.
Read the detailed description
The aim of this study is to measure the efficacy of cimetidine for acute, extrinsic-atopic dermatitis treated with standard therapy using SCORAD as the clinical outcome. This study also measure Immunoglobulin E, Interleukin-4, Interleukin-12, and Interferon-Ɣ serum levels before and after treatment.
- Being tested
- Cimetidine, Placebos
- Keywords
- Atopic Dermatitis, Cimetidine, Immunoglobulin E, Interleukin-4, Interleukin-12, Interferon Gamma, SCORAD, Treatment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CimetidineDrug
Antihistamine 2 antagonist
PlacebosDrug
Placebo drug
| Study group | Role | What they receive |
|---|---|---|
| Cimetidine | Active comparator | Not described Receives: Drug: Cimetidine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD change
Scoring Atopic Dermatitis (SCORAD) is a score to indicate the severity of atopic dermatitis.
The minimum score is 0, maximum score is 103. Mild 0 - 14 Moderate 15 - 39 Severe 40 - 103
The SCORAD before treatment was expected to be higher than after treatment. Outcome: change of SCORAD
Measured: 0, 2, 4, 6, 8 weeks
Immunoglobulin E change
Change of Immunoglobulin E
Measured: 0, 8 weeks
Secondary outcomes (3)
Interleukin-4 change
Change of Interleukin-4
Measured: 0, 8 weeks
Interleukin-12 change
Change of Interleukin-12
Measured: 0, 8 weeks
Interferon Gamma change
Change of Interferon Gamma
Measured: 0, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start26 Mar 2018
- Primary completion30 Mar 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018131
- Sponsor's protocol ID
- 0071
- Status last verified
- Oct 2019
- First submitted
- 10 Jul 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Novianto E, Jacoeb TNA, Indriatmi W, Suhendro, Setiabudy R, Setiabudy RD, Abdullah M, Rengganis I, Suwarsa O, Soebaryo RW. Effectiveness of Cimetidine as Adjuvant Therapy in the Treatment of Acute-Extrinsic Atopic Dermatitis: A Double-Blind Randomized Controlled Trial. Dermatol Ther (Heidelb). 2022 Mar;12(3):715-726. doi: 10.1007/s13555-022-00688-z. Epub 2022 Feb 17.
PubMed 35175572
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Cimetidin for Acute - Extrinsic Atopic Dermatitis Treated With Standard Therapy, a Study of Immunoglobulin E, Interleukin-4, Interleukin-12, and Interferon-Ɣ Serum Levels
- ClinicalTrials.gov ID
- NCT04018131
- Acronym / sponsor ID
- 0071
- Keywords
- Atopic Dermatitis, Cimetidine, Immunoglobulin E, Interleukin-4, Interleukin-12, Interferon Gamma, SCORAD, Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 12 Jul 2019 (actual)
- 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.
Extrinsic - atopic dermatitis is characterized by increased of IgE serum levels. Acute extrinsic - atopic dermatitis is a type 1 hypersensitivity that involve various inflammatory mediator including Interleukin-4, Interleukin-12, and Interferon-Ɣ. Recent treatment of atopic dermatitis mainly focused on reducing the inflammation through topical and systemic regiments. However, no systemic medication could control the atopic dermatitis remission yet, and the current immunosuppressive agent used may cause many side effects if administered on a long term basis.
In the future, treatment of atopic dermatitis were specifically targeted to inhibit the role of Th2. Cimetidine is H2 receptor antihistamine that has been widely used as gastrointestinal medication for a long time. Cimetidine could modulate the immune system by activating the Th1 and lowering the Th2 activity, and lowering the IgE levels thus reducing the severity of atopic dermatitis.
Detailed description
The aim of this study is to measure the efficacy of cimetidine for acute, extrinsic-atopic dermatitis treated with standard therapy using SCORAD as the clinical outcome. This study also measure Immunoglobulin E, Interleukin-4, Interleukin-12, and Interferon-Ɣ serum levels before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cimetidine | Active comparator | Drug: Cimetidine |
| Placebo | Placebo comparator | Drug: Placebos |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Atopic dermatitis patients diagnosed with Hanifin Rajka criteria
- Acute extrinsic atopic dermatitis
- IgE levels above 200 IU/mL
- Minimum weight 15kg
Key exclusion criteria (5 listed)
- Consumption of corticosteroid and systemic immunosuppressant within the last 2 weeks
- Chronic lesion
- Consumption of drugs that reacts with cimetidine
- Disturbance in lab results including complete blood count, liver function, and renal function.
- Other conditions that might increase IgE levels
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 |
|---|---|---|
| CimetidineAntihistamine 2 antagonist | Drug | Cimetidine |
| PlacebosPlacebo drug | Drug | Placebo |
Primary outcome
SCORAD change
Time frame: 0, 2, 4, 6, 8 weeks
Scoring Atopic Dermatitis (SCORAD) is a score to indicate the severity of atopic dermatitis. The minimum score is 0, maximum score is 103. Mild 0 - 14 Moderate 15 - 39 Severe 40 - 103 The SCORAD before treatment was expected to be higher than after treatment. Outcome: change of SCORAD
Immunoglobulin E change
Time frame: 0, 8 weeks
Change of Immunoglobulin E
3 secondary outcomes
Interleukin-4 change
Time frame: 0, 8 weeks
Interleukin-12 change
Time frame: 0, 8 weeks
Interferon Gamma change
Time frame: 0, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Derived from this study: PubMed 35175572Novianto E, Jacoeb TNA, Indriatmi W, Suhendro, Setiabudy R, Setiabudy RD, Abdullah M, Rengganis I, Suwarsa O, Soebaryo RW. Effectiveness of Cimetidine as Adjuvant Therapy in the Treatment of Acute-Extrinsic Atopic Dermatitis: A Double-Blind Randomized Controlled Trial. Dermatol Ther (Heidelb). 2022 Mar;12(3):715-726. doi: 10.1007/s13555-022-00688-z. Epub 2022 Feb 17.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cimetidine in people with Atopic Dermatitis and Immunoglobulin E Concentration, Serum, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
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 5 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: status not confirmed, as of the sponsor's last update on 4 Oct 2019. 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 Indonesia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Endi Novianto (+628161309063, drendinovianto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCORAD change (time frame: 0, 2, 4, 6, 8 weeks). The study lists 2 primary outcomes in all. 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 NCT04018131, which also lists 1 linked publication.
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 4 Oct 2019.