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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01024374
Other study ID # All-E-M-13244-01/02-10-09
Secondary ID
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
Est. completion date
Est. primary completion date
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


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Allergisa Pesquisa Dermato-Cosmetica LTDA Galderma
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