- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01024374
Evaluation of the Effectiveness of a Product Containing Topical Hydrocortisone in the Treatment of Seborrheic Dermatitis of the Face (13244/2009)
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
Conditions
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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.
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