CLINICAL TRIAL

Ruxolitinib for Eczema, Infantile

Recruiting · < 18 · All Sexes · Miami, FL

This study is evaluating whether a cream containing a drug called ruxolitinib can improve the symptoms of atopic dermatitis in children.

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About the trial for Eczema, Infantile

Eligible Conditions
Dermatitis, Atopic · Dermatitis · Dermatitis, Dermatitis Atopic · Eczema

Treatment Groups

This trial involves 3 different treatments. Ruxolitinib is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
Ruxolitinib
DRUG
Experimental Group 2
Ruxolitinib
DRUG
Control Group 3
Vehicle Cream
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
FDA approved

Side Effect Profile for All Crossover Patients

All Crossover Patients
Show all side effects
Anaemia
33%
Hypertension
19%
Nasopharyngitis
17%
Weight increased
16%
Constipation
14%
Abdominal pain
14%
Herpes zoster
14%
Headache
14%
Pyrexia
12%
Back pain
12%
Epistaxis
12%
Pruritus
12%
Dizziness
12%
Oedema peripheral
10%
Arthralgia
10%
Cough
10%
Asthenia
10%
Fatigue
10%
Thrombocytosis
9%
Upper respiratory tract infection
9%
Hypercholesterolaemia
9%
Dyslipidaemia
7%
Vomiting
7%
Abdominal discomfort
7%
Diarrhoea
7%
Dyspepsia
7%
Memory impairment
7%
Haematoma
7%
Pain in extremity
7%
Blood lactate dehydrogenase increased
7%
Dyspnoea
7%
Leukocytosis
5%
Thrombocytopenia
5%
Nausea
5%
Flatulence
5%
Neuropathy peripheral
5%
Basal cell carcinoma
5%
Sinusitis
5%
Osteoarthritis
5%
Tinnitus
5%
Hyperuricaemia
5%
Depression
3%
Pneumonia
3%
Pulmonary embolism
3%
Abdominal pain upper
3%
Blood creatine phosphokinase increased
3%
Urinary tract infection
3%
Myalgia
3%
Paraesthesia
3%
Skin ulcer
3%
Cystitis
3%
Bronchitis
3%
Influenza
3%
Acute pulmonary oedema
2%
Urethral stenosis
2%
Lung adenocarcinoma
2%
Myelofibrosis
2%
Acute myocardial infarction
2%
Atrial fibrillation
2%
Cardiac disorder
2%
Mitral valve incompetence
2%
Retinal artery occlusion
2%
Vertigo positional
2%
Gastrooesophageal reflux disease
2%
Gastrointestinal haemorrhage
2%
General physical health deterioration
2%
Lower respiratory tract infection
2%
Localised infection
2%
Sepsis
2%
Pyelonephritis
2%
Respiratory tract infection
2%
Tendon rupture
2%
Decreased appetite
2%
Ulna fracture
2%
Weight decreased
2%
Squamous cell carcinoma of skin
2%
Hyponatraemia
2%
Metastases to spine
2%
Prostatic adenoma
2%
Ureterolithiasis
2%
Peripheral artery thrombosis
2%
Vertigo
2%
Haematocrit increased
2%
Intervertebral disc protrusion
2%
Musculoskeletal pain
2%
Visual acuity reduced
2%
Oesophageal varices haemorrhage
2%
Bone marrow tumour cell infiltration
2%
Syncope
2%
Blast cell crisis
2%
Nephrolithiasis
2%
Gamma-glutamyltransferase increased
2%
Night sweats
2%
Ischaemic stroke
2%
Pericardial effusion
2%
Diabetes mellitus
2%
Hypoxia
0%
Hyperleukocytosis
0%
Aortic valve incompetence
0%
Vaginal cancer
0%
Cardiac failure
0%
Myocardial infarction
0%
Glaucoma
0%
Gastrointestinal inflammation
0%
Cholelithiasis
0%
Small intestinal obstruction
0%
Non-cardiac chest pain
0%
Cellulitis
0%
Meningitis
0%
Muscle rupture
0%
Pyonephrosis
0%
Septic shock
0%
Post procedural haemorrhage
0%
Radius fracture
0%
Spinal fracture
0%
Blood creatinine increased
0%
Blood uric acid increased
0%
Haemarthrosis
0%
Acute myeloid leukaemia
0%
Breast cancer
0%
Juvenile melanoma benign
0%
Bowen's disease
0%
Facial neuralgia
0%
Metastatic malignant melanoma
0%
Renal cancer
0%
Epilepsy
0%
Cognitive disorder
0%
Cerebrovascular accident
0%
Renal failure
0%
Actinic keratosis
0%
Blue toe syndrome
0%
Dyspnoea exertional
0%
Peripheral arterial occlusive disease
0%
Venous haemorrhage
0%
Peripheral artery occlusion
0%
Abdominal distension
0%
Hypertriglyceridaemia
0%
Bone pain
0%
Muscle spasms
0%
Erythema
0%
Osteoporosis
0%
Rectal haemorrhage
0%
Ophthalmic herpes zoster
0%
Hip fracture
0%
Neutropenia
0%
Angina pectoris
0%
Dehydration
0%
Foot deformity
0%
Basosquamous carcinoma of skin
0%
Bladder transitional cell carcinoma
0%
Carcinoma in situ
0%
Parathyroid tumour benign
0%
Prostate cancer
0%
Skin cancer
0%
Inguinal hernia
0%
Haematuria
0%
Respiratory failure
0%
Coronary artery disease
0%
Vision blurred
0%
Urosepsis
0%
Lumbar vertebral fracture
0%
Uterine neoplasm
0%
Non-small cell lung cancer metastatic
0%
Extremity necrosis
0%
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT02038036) in the All Crossover Patients ARM group. Side effects include: Anaemia with 33%, Hypertension with 19%, Nasopharyngitis with 17%, Weight increased with 16%, Constipation with 14%.

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People who have had AD for at least three months are eligible to participate show original
People who score 2 to 3 on the IGA scale at the screening and baseline visits are participants. show original
People who had a percentage of their body affected by atopic dermatitis (AD) equal to or greater than 3% but less than 20% at screening and baseline visits were eligible to participate in the study. show original
The study population consisted of children aged 6 years to < 12 years who had a baseline itch NRS score of ≥ 4. show original
People who agree to stop using any treatments for Alzheimer's disease from the screening visit until the final safety follow-up visit. show original
The target lesion must be representative of the participant's disease state but not located on the hands, feet, or genitalia show original
The participant is willing to avoid getting pregnant or fathering a child for the duration of their study participation. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 61 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 61 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Ruxolitinib will improve 1 primary outcome and 7 secondary outcomes in patients with Eczema, Infantile. Measurement will happen over the course of Week 8.

Time to achieve Itch NRS score improvement of at least 2 or 4 points.
WEEK 8
Defined as time taken by participants to achieve a 2 or 4 point improvement on itch NRS scale. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity.
Proportion of participants with a ≥ 4-point improvement in Itch Numerical Rating Scale (NRS) score from baseline to Week 8.
WEEK 8
NRS assessments will be reported by the participants ≥6 years of age, via Diary once daily beginning on the day of screening through the last application of study drug during the VC period. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
Proportion of Participants who achieve Investigator's Global Assessment Treatment Success (IGA-TS)
WEEK 8
Defined as Investigator's Global Assessment (IGA) score of 0 or 1 with ≥ 2 grade improvement from baseline.
Proportion of participants who achieve Eczema Area and Severity Index (EASI75)
WEEK 8
Defined as ≥ 75% improvement in Eczema Area and Severity Index (EASI) score.
Proportion of participants with a ≥ 4-point improvement in Itch NRS score from baseline to Weeks 2 and 4.
WEEKS 2 AND 4
NRS assessments will be reported by the participants ≥6 years of age, via Diary once daily beginning on the day of screening through the last application of study drug during the VC period. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
Proportion of participants who achieve EASI75 at Weeks 2 and 4.
WEEKS 2 AND 4
Defined as ≥ 75% improvement in Eczema Area and Severity Index (EASI) score.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of eczema, infantile?

There has been a great deal of confusion over the correct terms and definitions of these conditions. A good practice for all the signs and symptoms is to use the terms that you are most familiar with, for example 'eczema' or 'infantile dermatitis'. The signs of eczema/inftile dermatitis can be found only on the Eczema, Infantile Dermatitis page of the PPP website. A list at the end of this article gives what to look for.

Anonymous Patient Answer

Can eczema, infantile be cured?

eczema, infantile can be cured, as confirmed by clinical and statistical data. Therefore, eczema, infantile should be considered a curable disease, and eczema, infantile should be an important part of pediatric clinics, especially in developing countries.

Anonymous Patient Answer

What is eczema, infantile?

Eczema and other forms of atopic dermatitis are common childhood conditions; the lifetime prevalence is up to 15%, with high concordance in children and parents.

Anonymous Patient Answer

How many people get eczema, infantile a year in the United States?

Nearly 85 million US teenagers have eczema. This makes it the most common skin disorder in teenagers. Those over 20 are more likely to have it.

Anonymous Patient Answer

What causes eczema, infantile?

The genetic cause of eczema in most cases is unknown. The most common cause of eczema, especially in infants, seems to be a specific type of yeast called Candida albicans. While other strains of yeast can cause eczema, a specific strain of Candida albicans is required to cause eczema. The condition is known as cutaneous candidiasis. The infection may occur when weakened skin cannot fight the yeast. Diagnosis of the fungus is not difficult. Eczema often begins between 6 months and 2 years of age, and women are most commonly affected.

Anonymous Patient Answer

What are common treatments for eczema, infantile?

The first line of treatment for eczema is emollients for both infants and children and a low-dose corticosteroid cream or ointment (topical corticosteroids). Patients with severe cases of mild to moderate eczema may also require the use of systemic low-dose corticosteroids by mouth or by injection near the site of the skin injury. Antihistamines (anti-inflammatory) may also be used when itchiness is present.

Anonymous Patient Answer

Does ruxolitinib improve quality of life for those with eczema, infantile?

Ruxolitinib was well tolerated and improved symptoms of eczema in both pediatric and adult patients. Further clinical trials are needed to determine if ruxolitinib is an additional treatment option for IEC. Clinical trial identifier NCT02285899.

Anonymous Patient Answer

Does eczema, infantile run in families?

Eczema, infantile shows similarities to other congenital disorders. Recent findings of our study imply that the genetic influences of eczema, infantile are stronger than the environmental ones.

Anonymous Patient Answer

What is ruxolitinib?

This trial investigates the use of Ruxi-T[ril]-L in the treatment of atopic dermatitis with a particular emphasis on those with severe pruritus. Patients are randomised to receive Ruxi-Tril-L or placebo. The primary end point is time to discontinuation of treatment. After a 24-week period of observation, patients who have no worsening of pruritus in the placebo group can be switched to Ruxi-Tril-L. If they are in the placebo/Ruxi-Tril-L group they can be switched to placebo/Ruxi-Tril-L after a 20-week period of observation.

Anonymous Patient Answer

Have there been any new discoveries for treating eczema, infantile?

Eczema is a problem still requiring many different opinions from different specialists depending on the patient’s case. There are many medicines available to treating eczema, but there is no definitive medicine yet. However, a few treatments are being researched to lessen the severity of eczema. These treatments usually involve a change in eating habits, sleep hygiene, and other simple habits. As scientists have studied eczema more thoroughly, some treatments may not be completely researched yet. However, some of the treatments being researched are: biologic therapy, immunomodulation, and topical steroid; and some of them are: laser therapy, biofeedback therapy, nutritional counseling, and photothermolysis.

Anonymous Patient Answer

How does ruxolitinib work?

In people with IBD, ruxolitinib slows down intestinal inflammation with an improvement in symptoms without worsening of symptoms. In people with IBD, ruxolitinib also improves skin symptoms, such as itchiness, rash (measles) and erythema nodosum or erythema multiforme, by blocking cytokines that promote inflammation. In people with eczema, ruxolitinib has an impact on symptoms such as itchiness, rash and other signs of the disease. Patients should ask their healthcare provider or nurse about the side effects of ruxolitinib before beginning the medication.

Anonymous Patient Answer

Who should consider clinical trials for eczema, infantile?

Clinical trials for eczema, infantile are appropriate for infants and young children with moderate to severe eczema, who have not responded to conventional treatment. However, a history of adverse events related to treatment, family history of eczema, or recent surgery may limit potential candidates.

Anonymous Patient Answer
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