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Dermatitis, AtopicNCT02585986

Intervention Study to Evaluate a Probiotic in Mild Atopic Dermatitis Young Patients

A study testing Probiotic in people with Dermatitis, Atopic, run by Biopolis S.L. at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to evaluate the beneficial effect of a probiotic preparation with an antiinflammatory and modulating activity on immunological processes, with positive results on different inflammatory and atopic conditions. Read more about this study

Who is it for?
Ages 4 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Dermatitis, Atopic
What is being tested?
Probiotic
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
1 siteSpain
Study dates
Jan 2016to Aug 2016
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 4 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • patients that are 4 to 17 years of age.
  • Patients diagnosed of atopic dermatitis according to Hanifin and Rajka diagnostic criteria for atopic dermatitis.
  • Patients with a SCORAD score ranging from 20 to 40.
  • Patients that are actually using, or in which the use of topic corticosteroids to treat the atopic dermatitis flare-ups.
  • Patients whose parents or legal representative have signed the informed consent. If the patient is 12 year old or older, the patient has to sign a consent to enter the trial.

Who cannot join

  • Pregnancy.
  • Breastfeeding.
  • Women of childbearing age that do not make a commitment to use any effective contraceptive method.
  • Phototherapy treatments to atopic dermatitis
  • Systemic corticoid therapy in the last two months.
  • Immunosuppressive or cytostatic treatment in the last two months.
Show all 14Show fewer
  • Probiotic treatment in the last two months.
  • Systemic antibiotic in the last four months.
  • Fever (axillary temperature > 37ºC or equivalent)
  • Severe allergic diseases-
  • Immunodeficiency or cancer related processes.
  • Other dermatological pathologies that could difficult the atopic dermatitis evaluation, or that require the continued use of topic corticosteroids.
  • Any contraindication to any product or drug used during the trial, according to their technical files.
  • Participation in any drug clinical trial in the last 3 months.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Centro Dermatologico Estetico de Alicante

    Alicante, Alicante, 03014

Other trials in Spain

About this study

Official title: Randomized, Double Blind, Placebo-controlled Intervention Study to Evaluate Safety and Efficiency of a Probiotic in Symptoms Reduction and Use of Topic Corticoids in Mild Atopic Dermatitis Patients Aged 4 to 17 Years

The aim of the study is to evaluate the beneficial effect of a probiotic preparation with an antiinflammatory and modulating activity on immunological processes, with positive results on different inflammatory and atopic conditions.

Read the detailed description

In this study the investigators evaluate the safety and efficacy of a probiotic formulation in the reduction of symptoms and use of topic and systemic corticosteroids and antihistamines in the treatment of mild atopic dermatitis according to Hanifin and Rajka diagnostic criteria for atopic dermatitis, with a SCORAD (Scoring Atopic Dermatitis) index of 20 to 40, in patients 4 to 18 years old, that require the use of said drugs due to disease flare-ups, and to whom the usage of topic corticoids to control said flare-ups is indicated.

Being tested
Probiotic, Placebo
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProbioticDietary supplement

    Also called Active formulation

    daily intake of 1 capsule probiotic

  • PlaceboDietary supplement

    daily intake of 1 capsule containing placebo

Study groups in NCT02585986
Study groupRoleWhat they receive
ProbioticActive comparatordaily intake of 1 capsule containing probiotic.
Receives: Dietary Supplement: Probiotic
PlaceboPlacebo comparatordaily intake of 1 capsule containing placebo
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time of use of topic corticosteroids

    Duration of treatment with topic corticosteroids

    Measured: twelve weeks

  2. Variation in SCORAD score during treatment

    Measured: twelve weeks

Secondary outcomes (3)

  1. Variation in the Global Clinical Impression (CGI) score during treatment

    Measured: twelve weeks

  2. Exposure to other treatments

    Duration of treatment with systemic corticosteroids or antihistamine drugs

    Measured: twelve weeks

  3. side effects due to treatment in two arms of treatment

    Number of side effects due to probiotic and due to placebo

    Measured: twelve weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionJul 2016
  4. Study completionAug 2016

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02585986
Sponsor's protocol ID
ATO/PRO1
Status last verified
Sep 2016
First submitted
13 Oct 2015
Last updated
13 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Ellis C, Luger T, Abeck D, Allen R, Graham-Brown RA, De Prost Y, Eichenfield LF, Ferrandiz C, Giannetti A, Hanifin J, Koo JY, Leung D, Lynde C, Ring J, Ruiz-Maldonado R, Saurat JH; ICCAD II Faculty. International Consensus Conference on Atopic Dermatitis II (ICCAD II): clinical update and current treatment strategies. Br J Dermatol. 2003 May;148 Suppl 63:3-10. doi: 10.1046/j.1365-2133.148.s63.1.x. No abstract available.

    PubMed 12694268

  • Leung DY, Bieber T. Atopic dermatitis. Lancet. 2003 Jan 11;361(9352):151-60. doi: 10.1016/S0140-6736(03)12193-9.

    PubMed 12531593

  • Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. doi: 10.1056/NEJMra074081. No abstract available.

    PubMed 18385500

  • Levy RM, Gelfand JM, Yan AC. The epidemiology of atopic dermatitis. Clin Dermatol. 2003 Mar-Apr;21(2):109-15. doi: 10.1016/s0738-081x(02)00360-7. No abstract available.

    PubMed 12706328

  • Su JC, Kemp AS, Varigos GA, Nolan TM. Atopic eczema: its impact on the family and financial cost. Arch Dis Child. 1997 Feb;76(2):159-62. doi: 10.1136/adc.76.2.159.

    PubMed 9068310

  • Simpson EL, Hanifin JM. Atopic dermatitis. J Am Acad Dermatol. 2005 Jul;53(1):115-28. doi: 10.1016/j.jaad.2005.01.130. No abstract available.

    PubMed 15965431

  • Boguniewicz M, Leung DY. 10. Atopic dermatitis. J Allergy Clin Immunol. 2006 Feb;117(2 Suppl Mini-Primer):S475-80. doi: 10.1016/j.jaci.2005.10.018.

    PubMed 16455350

  • Ridao M. Dermatitis atópica: clínica, diagnóstico diferencial y tratamiento. Pediatr Integral 2004:8:204-10.

  • Hanifin JM, Rajka G. Diagnosis features of atopic dermatitis. Acta Derm Venereol 1980;92:44-7.

  • Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. doi: 10.1159/000247298.

    PubMed 8435513

  • Sprikkelman AB, Tupker RA, Burgerhof H, Schouten JP, Brand PL, Heymans HS, van Aalderen WM. Severity scoring of atopic dermatitis: a comparison of three scoring systems. Allergy. 1997 Sep;52(9):944-9. doi: 10.1111/j.1398-9995.1997.tb01255.x.

    PubMed 9298180

  • Charman C, Williams H. Outcome measures of disease severity in atopic eczema. Arch Dermatol. 2000 Jun;136(6):763-9. doi: 10.1001/archderm.136.6.763.

    PubMed 10871941

  • Pucci N, Novembre E, Cammarata MG, Bernardini R, Monaco MG, Calogero C, Vierucci A. Scoring atopic dermatitis in infants and young children: distinctive features of the SCORAD index. Allergy. 2005 Jan;60(1):113-6. doi: 10.1111/j.1398-9995.2004.00622.x.

    PubMed 15575941

  • Bhor U, Pande S. Scoring systems in dermatology. Indian J Dermatol Venereol Leprol. 2006 Jul-Aug;72(4):315-21. doi: 10.4103/0378-6323.26722. No abstract available.

    PubMed 16880586

  • National Institute for health and clinical excellence. Atopic eczema in children. Management of atopic eczema in children from birth up to the age of 12 years. NICE clinical guideline 57. Dec 2007.

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic in people with Dermatitis, Atopic, run by Biopolis S.L. at 1 site in Spain.

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 5 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 13 Sep 2016. 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 Spain. 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?

Time of use of topic corticosteroids (time frame: twelve 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 NCT02585986, which also lists 23 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 13 Sep 2016.

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