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Evaluation of the Effectiveness of a Product Containing Topical Hydrocortisone in the Treatment of Seborrheic Dermatitis of the Face (13244/2009)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01024374
Recruitment Status : Unknown
Verified December 2009 by Allergisa Pesquisa Dermato-Cosmetica LTDA.
Recruitment status was:  Not yet recruiting
First Posted : December 2, 2009
Last Update Posted : December 2, 2009
Information provided by:
Allergisa Pesquisa Dermato-Cosmetica LTDA

Brief Summary:

Clinical single-blind randomized comparison with the overall objective of evaluating the clinical efficacy of the products Nutracort lotion and Nutracort cream in the treatment of seborrheic dermatitis on the face.

Will be held clinical and perceived efficacy assessment and instrumental measurements. Each product will be applied at half face for 7 consecutive days and all applications will be monitored in the research site. 60 volunteers will be recruited.

Evaluations will be held at the following times: T0 - before the initial application of the product; T1 - 24 hours after starting treatment, T2 - 48 hours after starting treatment, T3 - 72 hours after initiation of treatment, T4 - 96 hours after the start treatment, T7 - 7 days after initiation of treatment.

Condition or disease
Seborrheic Dermatitis

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Avaliação da eficácia de um Produto de Uso tópico Contendo Hidrocortisona no Tratamento de Dermatite seborréica na Face.
Study Start Date : April 2010

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy subjects with seborrheic dermatitis on both sides of the face, both sexes, aged 18 to 60 years, skin types I through IV.

Inclusion Criteria:

  • Healthy subjects
  • Subjects with seborrheic dermatitis on both sides of the face
  • both sexes
  • aged 18 to 60 years
  • skin types I through IV.

Exclusion Criteria:

  • pregnancy / lactation
  • skin condition in the area of application of the product
  • diabetes
  • immune insufficiency
  • subjects that are using systemic corticoids
  • subjects that are using immunosuppressors
  • skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis
  • history of reaction to the product category
  • other diseases or medications that might interfere directly in the study or endanger the health of the subject
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Responsible Party: Douglas - P&D, Galderma Identifier: NCT01024374    
Other Study ID Numbers: All-E-M-13244-01/02-10-09
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: December 2009
Additional relevant MeSH terms:
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Dermatitis, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous