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

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585986
• Other study ID #: ATO/PRO1
• Status: Completed
• Phase: N/A
• First received: October 13, 2015
• Last updated: September 11, 2016
• Start date: January 2016
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Biopolis S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Dietary Supplement:
• Probiotic
daily intake of 1 capsule probiotic
• Placebo
daily intake of 1 capsule containing placebo

Locations

Country	Name	City	State
Spain	Centro Dermatologico Estetico de Alicante	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
Biopolis S.L.	Korott, S.L.

Country where clinical trial is conducted

Spain, 

References & Publications (21)

Bhor U, Pande S. Scoring systems in dermatology. Indian J Dermatol Venereol Leprol. 2006 Jul-Aug;72(4):315-21. Review. — View Citation

Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. doi: 10.1056/NEJMra074081. — View Citation

Boguniewicz M, Leung DY. 10. Atopic dermatitis. J Allergy Clin Immunol. 2006 Feb;117(2 Suppl Mini-Primer):S475-80. Review. — View Citation

Boguniewicz M, Schmid-Grendelmeier P, Leung DY. Atopic dermatitis. J Allergy Clin Immunol. 2006 Jul;118(1):40-3. Epub 2006 Jun 6. Review. — View Citation

Castro AP. Calcineurin inhibitors in the treatment of allergic dermatitis. J Pediatr (Rio J). 2006 Nov;82(5 Suppl):S166-72. Review. — View Citation

Charman C, Williams H. Outcome measures of disease severity in atopic eczema. Arch Dermatol. 2000 Jun;136(6):763-9. Review. — View Citation

de Benedictis FM, de Benedictis D, Canonica GW. New oral H1 antihistamines in children: facts and unmeet needs. Allergy. 2008 Oct;63(10):1395-404. doi: 10.1111/j.1398-9995.2008.01771.x. Review. — View Citation

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. Review. — View Citation

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

Leung DY, Bieber T. Atopic dermatitis. Lancet. 2003 Jan 11;361(9352):151-60. Review. — View Citation

Levy RM, Gelfand JM, Yan AC. The epidemiology of atopic dermatitis. Clin Dermatol. 2003 Mar-Apr;21(2):109-15. Review. — View Citation

Meurer M, Fartasch M, Albrecht G, Vogt T, Worm M, Ruzicka T, Altmeyer PJ, Schneider D, Weidinger G, Braeutigam M; CASM-DE-01 Study Group. Long-term efficacy and safety of pimecrolimus cream 1% in adults with moderate atopic dermatitis. Dermatology. 2004;208(4):365-72. — View Citation

Meurer M, Fölster-Holst R, Wozel G, Weidinger G, Jünger M, Bräutigam M; CASM-DE-01 study group. Pimecrolimus cream in the long-term management of atopic dermatitis in adults: a six-month study. Dermatology. 2002;205(3):271-7. — View Citation

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.

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. — View Citation

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

Schoepe S, Schäcke H, May E, Asadullah K. Glucocorticoid therapy-induced skin atrophy. Exp Dermatol. 2006 Jun;15(6):406-20. Review. — View Citation

Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. — View Citation

Simpson EL, Hanifin JM. Atopic dermatitis. J Am Acad Dermatol. 2005 Jul;53(1):115-28. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of use of topic corticosteroids	Duration of treatment with topic corticosteroids	twelve weeks	No
Primary	Variation in SCORAD score during treatment		twelve weeks	No
Secondary	Variation in the Global Clinical Impression (CGI) score during treatment		twelve weeks	No
Secondary	Exposure to other treatments	Duration of treatment with systemic corticosteroids or antihistamine drugs	twelve weeks	No
Secondary	side effects due to treatment in two arms of treatment	Number of side effects due to probiotic and due to placebo	twelve weeks	Yes