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| Name | Class |
|---|---|
| Fleury | UNKNOWN |
| Associacao Fundo de Incentivo a Psicofarmcologia | OTHER |
| Bayer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment 1 | Active Comparator | topical acid azelaic, used 2 times a day for 6 months |
|
| treatment 2 | Active Comparator | contraceptive with drospirenone/ethinyl estradiol used for 6 months |
|
| control | No Intervention | control group ( only take biopsies and blood samples ) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treatment azelaic acid (azelan) | Drug | treatment for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation of the treatment group | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Photographic study of the treatment group | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Application of the questionnaire index of quality of life in Acne | AcneQol (Girman et al, 1996, Martin et al, 2001, Fehnel et al, 2003), | 6 months |
| Immunohistochemical analysis with quantitative digital blind: |
Inclusion Criteria:
To all:
For the oral contraceptives group:
For the azelaic acid group:
Exclusion Criteria:
For all
For the group treated with oral contraceptives:
1. Presence of contraindications to oral contraceptive use:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| marco rocha, md | Contact | 55-11-55799331 | marcoderm@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| marco rocha, md | UNIFESP-EPM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of São Paulo-Dermatology | Recruiting | São Paulo | São Paulo | 04038-001 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19588637 | Background | Bhambri S, Del Rosso JQ, Bhambri A. Pathogenesis of acne vulgaris: recent advances. J Drugs Dermatol. 2009 Jul;8(7):615-8. | |
| 21710106 | Background | Shen Y, Wang T, Zhou C, Wang X, Ding X, Tian S, Liu Y, Peng G, Xue S, Zhou J, Wang R, Meng X, Pei G, Bai Y, Liu Q, Li H, Zhang J. Prevalence of acne vulgaris in Chinese adolescents and adults: a community-based study of 17,345 subjects in six cities. Acta Derm Venereol. 2012 Jan;92(1):40-4. doi: 10.2340/00015555-1164. |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C010038 | azelaic acid |
| C534342 | drospirenone and ethinyl estradiol combination |
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| dorspirenone/ethynil estradiol | Drug |
|
|
For immunohistochemistry will be used the following markers:
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.
| 6 months |
| Serological blood measurements | 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. | 6 months |
| 12833004 | Background | Gollnick H, Cunliffe W, Berson D, Dreno B, Finlay A, Leyden JJ, Shalita AR, Thiboutot D; Global Alliance to Improve Outcomes in Acne. Management of acne: a report from a Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol. 2003 Jul;49(1 Suppl):S1-37. doi: 10.1067/mjd.2003.618. No abstract available. |
| 15556729 | Background | Thiboutot D. Acne: hormonal concepts and therapy. Clin Dermatol. 2004 Sep-Oct;22(5):419-28. doi: 10.1016/j.clindermatol.2004.03.010. |
| 19555434 | Background | Kurokawa I, Danby FW, Ju Q, Wang X, Xiang LF, Xia L, Chen W, Nagy I, Picardo M, Suh DH, Ganceviciene R, Schagen S, Tsatsou F, Zouboulis CC. New developments in our understanding of acne pathogenesis and treatment. Exp Dermatol. 2009 Oct;18(10):821-32. doi: 10.1111/j.1600-0625.2009.00890.x. Epub 2009 Jun 23. |
| 9703121 | Background | White GM. Recent findings in the epidemiologic evidence, classification, and subtypes of acne vulgaris. J Am Acad Dermatol. 1998 Aug;39(2 Pt 3):S34-7. doi: 10.1016/s0190-9622(98)70442-6. |
| 10495379 | Background | Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999 Oct;41(4):577-80. |
| 9039297 | Background | Goulden V, Clark SM, Cunliffe WJ. Post-adolescent acne: a review of clinical features. Br J Dermatol. 1997 Jan;136(1):66-70. |
| 11843213 | Background | Poli F, Dreno B, Verschoore M. An epidemiological study of acne in female adults: results of a survey conducted in France. J Eur Acad Dermatol Venereol. 2001 Nov;15(6):541-5. doi: 10.1046/j.1468-3083.2001.00357.x. |