The Influence of Peripheral Androgen Conversion at Women Adult Acne

NCT01850095 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-05-09

No results posted yet for this study

Summary

Acne vulgaris is a chronic inflammatory disease that affects the pilosebaceous unit. Recent studies have demonstrated an increase number of acne cases in adult women. These cases are predominantly normoandrogenic and have some clinical differences when compared with the most common group, the adolescent. The local glandular metabolism converts some hormonal precursors to more active substances that increase the sebum production, leaving these areas more prone to increase the colonization to Propionibacterium Acnes (P. Acnes). Toll-like receptor 2, expressed by inflammatory cells play a crucial role in the innate immune response to this bacterium. Previous studies confirm that exist a reduced expression of CD1d by keratinocytes in acne lesion, what can be interpreted as a low antigen-present function. The influence of hormonal alteration in the sebaceous glands could modulate the expressions of TLR-2 and CD1d explaining the persistence of lesions in adult women. The change to more estrogenic metabolism, with use of specific contraceptive pills could normalize this immune-mediated inflammatory process.

Objective

To analyze how the peripheral androgen conversion can influence the toll-like receptor 2 and CD1d expression in women with inflammatory acne before and after 6 months of oral contraceptives with anti-androgen activity.

Conditions

  • Acne
  • Quality of Life

Interventions

DRUG

treatment azelaic acid (azelan)

treatment for 6 months

DRUG

dorspirenone/ethynil estradiol

Sponsors & Collaborators

  • Fleury

    collaborator UNKNOWN
  • Associacao Fundo de Incentivo a Psicofarmcologia

    collaborator OTHER
  • Bayer

    collaborator INDUSTRY
  • Marco Alexandre Dias da Rocha

    lead OTHER

Principal Investigators

  • marco rocha, md · UNIFESP-EPM

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
26 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-06-30
Completion
2015-01-31

Countries

  • Brazil

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01850095 on ClinicalTrials.gov