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The Influence of Peripheral Androgen Conversion at Women Adult Acne

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ClinicalTrials.gov Identifier: NCT01850095
Recruitment Status : Unknown
Verified May 2013 by Marco Alexandre Dias da Rocha, Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : May 9, 2013
Last Update Posted : May 9, 2013
Sponsor:
Collaborators:
Fleury
Associacao Fundo de Incentivo a Psicofarmcologia
Bayer
Information provided by (Responsible Party):
Marco Alexandre Dias da Rocha, Federal University of São Paulo

Tracking Information
First Submitted Date  ICMJE May 1, 2013
First Posted Date  ICMJE May 9, 2013
Last Update Posted Date May 9, 2013
Study Start Date  ICMJE March 2012
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2013)
Clinical evaluation of the treatment group [ Time Frame: 6 months ]
by the researcher: by counting the inflammatory lesions. by the research subjects: the general appearance of skin at the time of study entry and after the treatment. Will be used a 4-point scale: 0 = no acne, 1 = mild acne, moderate acne, and 2 = 4 = severe acne.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2013)
Photographic study of the treatment group [ Time Frame: 6 months ]
This evaluation will be performed by two independent dermatologists, the degree of change in the intensity of acne, comparing the pre and post treatment photos through a 5-point scale: -2 = much worse, -1 = worse, 0 = unchanged; +1 = better, +2 = much better.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 8, 2013)
  • Application of the questionnaire index of quality of life in Acne [ Time Frame: 6 months ]
    AcneQol (Girman et al, 1996, Martin et al, 2001, Fehnel et al, 2003),
  • Immunohistochemical analysis with quantitative digital blind: [ Time Frame: 6 months ]
    For immunohistochemistry will be used the following markers:
    • a polyclonal rabbit anti-TLR2 (ABBIOTEC 251,110) Biogen, Brazil.
    • mouse monoclonal anti-CD1d, clone NOR3.2 (Genway 20-272-1903). Biogen, Brazil.
    Statistical comparisons are made between the following groups: control group 2 and the region with inflammatory lesions in the treatment group, region and region inflammatory non-inflammatory group of medications and treatment before inflammatory region before and after treatment.
  • Serological blood measurements [ Time Frame: 6 months ]
    Comparison of serological blood measurements of free and total testosterone, dihydroepiandrosterone sulfate (DHEAS), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and androsterone glucuronide, before and after the treatment.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Influence of Peripheral Androgen Conversion at Women Adult Acne
Official Title  ICMJE The Influence of Peripheral Androgen Conversion at Toll-like Receptors-2 and CD1d Expressions in Human Keratinocytes as Well as Their Modulation After 6 Months Treatment With Oral Contraceptive.
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Acne
  • Quality of Life
Intervention  ICMJE
  • Drug: treatment azelaic acid (azelan)
    treatment for 6 months
    Other Name: azelaic acid (azelan)
  • Drug: dorspirenone/ethynil estradiol
    Other Name: (yaz)
Study Arms  ICMJE
  • Active Comparator: treatment 1
    topical acid azelaic, used 2 times a day for 6 months
    Intervention: Drug: treatment azelaic acid (azelan)
  • Active Comparator: treatment 2
    contraceptive with drospirenone/ethinyl estradiol used for 6 months
    Intervention: Drug: dorspirenone/ethynil estradiol
  • No Intervention: control
    control group ( only take biopsies and blood samples )
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 8, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2015
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

To all:

  1. Signing the consent form before any study procedures;
  2. women aged 26 to 44 years, not pregnant and in good health;
  3. no topical treatment for acne in the past three months,
  4. absence of the use of oral antibiotics in the last 3 months;
  5. absence of the use of isotretinoin in the last 2 years;
  6. absence of oral contraceptive use in the last 3 months;
  7. absence of clinical evidence of immunosuppression and
  8. accordance with the conditions of study, ability to understand and strictly follow the instructions given.

For the oral contraceptives group:

  1. No contraindications to the use hormonal contraceptives.

For the azelaic acid group:

  1. Absence of hypersensitivity to azelaic acid.

Exclusion Criteria:

For all

  1. Women who do not agree with the conditions of the study or without the ability to understand and closely follow the guidelines received without availability to attend the revaluations or who refuse to sign the Informed Consent Form;
  2. pregnant or lactating women;
  3. use of the following oral medications: cortisone derivatives, lithium, anticonvulsants, isoniazid, oral contraceptives, androgens, danazol, iodides, bromides, disulfiram, cyclosporine, azathioprine, thiuram, vitamins B2, B6 and B12;
  4. treatment of facial skin with topical retinoids (tretinoin and adapalene), azelaic acid, benzoyl peroxide, clindamycin, erythromycin, nicotinamina, alone or in combination, in the past 3 months;
  5. treatment with oral antibiotics in the past 3 months;
  6. acnogenics cosmetics.

For the group treated with oral contraceptives:

1. Presence of contraindications to oral contraceptive use:

  1. Smokers over 35 years;
  2. history of deep venous thrombosis;
  3. history of stroke;
  4. history of breast cancer;
  5. presence of jaundice, and severe active liver disease or biliary disease;
  6. diabetes mellitus for more than 20 years or eye injury, or neurological impairment;
  7. blood pressure greater than or equal to 160 to 100 for systolic and diastolic;
  8. cardiovascular disease and
  9. presence of severe headache associated with blurred vision frequently.

For the group treated with azelaic acid:

1.Presense of allergic and / or irritating symptoms to the use of azelaic acid.

For the control group 1:

1. History, clinical signs and / or laboratory evidence of hyperandrogenism. 2 .Presence of inflammatory acne.

-

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 26 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01850095
Other Study ID Numbers  ICMJE 1622/11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marco Alexandre Dias da Rocha, Federal University of São Paulo
Study Sponsor  ICMJE Marco Alexandre Dias da Rocha
Collaborators  ICMJE
  • Fleury
  • Associacao Fundo de Incentivo a Psicofarmcologia
  • Bayer
Investigators  ICMJE
Principal Investigator: marco rocha, md UNIFESP-EPM
PRS Account Federal University of São Paulo
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP