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

December 1, 2009 updated by: Allergisa Pesquisa Dermato-Cosmetica LTDA

Avaliação da eficácia de um Produto de Uso tópico Contendo Hidrocortisona no Tratamento de Dermatite seborréica na Face.

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.

Study Overview

Status

Unknown

Study Type

Observational

Enrollment (Anticipated)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (ESTIMATE)

December 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 2, 2009

Last Update Submitted That Met QC Criteria

December 1, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • All-E-M-13244-01/02-10-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Seborrheic Dermatitis

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