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

NCT01024374 | Unknown

• 1 other identifier: All-E-M-13244-01/02-10-09
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Seborrheic Dermatitis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Healthy subjects
• Subjects with seborrheic dermatitis on both sides of the face
• both sexes
• aged 18 to 60 years
• skin types I through IV.

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergisa Pesquisa Dermato-Cosmetica LTDA: lead
• Galderma R&D: collaborator

MeSH Terms

Conditions

Dermatitis, Seborrheic

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 2, 2009
• Study Start: April 1, 2010
• Last Updated: December 2, 2009

Record last verified: 2009-12