The Influence of Peripheral Androgen Conversion at Women Adult Acne
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Acne Quality of Life||Drug: treatment azelaic acid (azelan) Drug: dorspirenone/ethynil estradiol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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.|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||January 2015|
Active Comparator: treatment 1
topical acid azelaic, used 2 times a day for 6 months
Drug: treatment azelaic acid (azelan)
treatment for 6 months
Other Name: azelaic acid (azelan)
Active Comparator: treatment 2
contraceptive with drospirenone/ethinyl estradiol used for 6 months
Drug: dorspirenone/ethynil estradiol
Other Name: (yaz)
No Intervention: control
control group ( only take biopsies and blood samples )
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850095
|Contact: marco rocha, firstname.lastname@example.org|
|Federal University of São Paulo-Dermatology||Recruiting|
|são Paulo, Brazil, 04038-001|
|Contact: marco rocha, md 55-11-55799331 email@example.com|
|Principal Investigator: marco rocha, md|
|Sub-Investigator: edileia bagatin, Phd|
|Principal Investigator:||marco rocha, md||UNIFESP-EPM|