Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Allergisa Pesquisa Dermato-Cosmetica LTDA.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Galderma
Information provided by:
Allergisa Pesquisa Dermato-Cosmetica LTDA
ClinicalTrials.gov Identifier:
NCT01024374
First received: November 30, 2009
Last updated: December 1, 2009
Last verified: December 2009
  Purpose

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
Seborrheic Dermatitis

Study Type: Observational
Study Design: 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.

Further study details as provided by Allergisa Pesquisa Dermato-Cosmetica LTDA:

Estimated Enrollment: 60
Study Start Date: April 2010
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Douglas - P&D, Galderma
ClinicalTrials.gov Identifier: NCT01024374     History of Changes
Other Study ID Numbers: All-E-M-13244-01/02-10-09
Study First Received: November 30, 2009
Last Updated: December 1, 2009
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Seborrheic
Sebaceous Gland Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 20, 2014