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

NCT ID: NCT01024374

Last Updated: 2009-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Seborrheic Dermatitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role collaborator

Allergisa Pesquisa Dermato-Cosmetica LTDA

INDUSTRY

Sponsor Role lead

Responsible Party

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Galderma

Other Identifiers

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All-E-M-13244-01/02-10-09

Identifier Type: -

Identifier Source: org_study_id