Status:

UNKNOWN

Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea

Lead Sponsor:

Federal University of São Paulo

Conditions:

Seborrhea

Seborrheic Dermatitis

Eligibility:

All Genders

18-40 years

Phase:

PHASE4

Brief Summary

Oral isotretinoin is the gold standard drug to treat moderate to severe acne. Other indications like seborrhea, seborrheic dermatitis have been suggested. There is risk of reversible mucocutaneous sid...

Detailed Description

Oral isotretinoin is a retinoid that controls gene expression related to cellular proliferation, differentiation, with specific action over sebocytes, reducting sebaceous gland size and secretion rate...

Eligibility Criteria

Inclusion

  • consent form signature
  • presence of seborrhea and / or seborrheic dermatitis on face and scalp
  • good health
  • no previous treatment with oral isotretinoin in the last 6 months
  • normal laboratorial tests: pregnancy test, blood counting, transaminases and lipide profile
  • concordance on use of two anticonceptional methods, during and until one month after the end of the study

Exclusion

  • difficulty to follow study conditions
  • pregnancy risk
  • diabetes
  • collagen diseases
  • bone or muscles diseases
  • alcohol abuse
  • hypervitaminosis A

Key Trial Info

Start Date :

October 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2012

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT01139749

Start Date

October 1 2011

End Date

December 1 2012

Last Update

October 12 2011

Active Locations (1)

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1

Federal University of Sao Paulo - Dermatology Department - Cosmetic Dermatology Unit

São Paulo, São Paulo, Brazil, 04022-000