The Influence of Peripheral Androgen Conversion at Women Adult Acne

NCT01850095 | Unknown DMC

• 1 other identifier: 1622/11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne; Quality of Life

Keywords

acne; adult; women; TLR; CD1d; androgens

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Photographic study of the treatment group

  6 months

Other Outcomes (3)

• Application of the questionnaire index of quality of life in Acne

  6 months

• Immunohistochemical analysis with quantitative digital blind:

  6 months

• Serological blood measurements

  6 months

Study Arms (3)

treatment 1

ACTIVE COMPARATOR

topical acid azelaic, used 2 times a day for 6 months

Drug: treatment azelaic acid (azelan)

treatment 2

ACTIVE COMPARATOR

contraceptive with drospirenone/ethinyl estradiol used for 6 months

Drug: dorspirenone/ethynil estradiol

control

NO INTERVENTION

control group ( only take biopsies and blood samples )

Interventions

treatment azelaic acid (azelan) DRUG

treatment for 6 months

Also known as: azelaic acid (azelan)

treatment 1

dorspirenone/ethynil estradiol DRUG

Also known as: (yaz)

treatment 2

Eligibility Criteria

• Age: 26 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To all:
• Signing the consent form before any study procedures;
• women aged 26 to 44 years, not pregnant and in good health;
• no topical treatment for acne in the past three months,
• absence of the use of oral antibiotics in the last 3 months;
• absence of the use of isotretinoin in the last 2 years;
• absence of oral contraceptive use in the last 3 months;
• absence of clinical evidence of immunosuppression and
• accordance with the conditions of study, ability to understand and strictly follow the instructions given.
• For the oral contraceptives group:
• No contraindications to the use hormonal contraceptives.
• For the azelaic acid group:
• Absence of hypersensitivity to azelaic acid.

You may not qualify if:

• For all
• 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;
• pregnant or lactating women;
• 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;
• 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;
• treatment with oral antibiotics in the past 3 months;
• acnogenics cosmetics.
• For the group treated with oral contraceptives:
• \. Presence of contraindications to oral contraceptive use:
• Smokers over 35 years;
• history of deep venous thrombosis;
• history of stroke;
• history of breast cancer;
• presence of jaundice, and severe active liver disease or biliary disease;
• diabetes mellitus for more than 20 years or eye injury, or neurological impairment;

Sponsors & Collaborators

• Marco Alexandre Dias da Rocha: lead
• Fleury: collaborator
• Associacao Fundo de Incentivo a Psicofarmcologia: collaborator
• Bayer: collaborator

Study Sites (1)

Federal University of São Paulo-Dermatology

São Paulo, São Paulo, 04038-001, Brazil

RECRUITING

Related Publications (9)

• Bhambri S, Del Rosso JQ, Bhambri A. Pathogenesis of acne vulgaris: recent advances. J Drugs Dermatol. 2009 Jul;8(7):615-8.

  PMID: 19588637 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.

  PMID: 21710106 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.

  PMID: 12833004 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.

  PMID: 15556729 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.

  PMID: 19555434 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.

  PMID: 9703121 BACKGROUND

• Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999 Oct;41(4):577-80.

  PMID: 10495379 BACKGROUND

• Goulden V, Clark SM, Cunliffe WJ. Post-adolescent acne: a review of clinical features. Br J Dermatol. 1997 Jan;136(1):66-70.

  PMID: 9039297 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.

  PMID: 11843213 BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Interventions

azelaic acid; drospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• marco rocha, md

  UNIFESP-EPM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

marco rocha, md

CONTACT

55-11-55799331; marcoderm@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: May 9, 2013
• Study Start: March 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: January 1, 2015
• Last Updated: May 9, 2013

Record last verified: 2013-05

Locations

BR (1)