Evaluation of the Effectiveness of a Product Containing Topical Hydrocortisone in the Treatment of Seborrheic Dermatitis of the Face

Seborrheic Dermatitis Clinical Trial

— 13244/2009  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01024374
• Other study ID #: All-E-M-13244-01/02-10-09
• Status: Not yet recruiting
• Phase: N/A
• First received: November 30, 2009
• Last updated: December 1, 2009
• Start date: April 2010

Study information

• Verified date: December 2009
• Source: Allergisa Pesquisa Dermato-Cosmetica LTDA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Seborrheic
• Eczema
• Seborrheic Dermatitis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Allergisa Pesquisa Dermato-Cosmetica LTDA	Galderma