The Influence of Peripheral Androgen Conversion at Women Adult Acne

NCT ID: NCT01850095

Last Updated: 2013-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

treatment 1

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

Group Type: ACTIVE_COMPARATOR

treatment azelaic acid (azelan)

Intervention Type: DRUG

treatment for 6 months

treatment 2

contraceptive with drospirenone/ethinyl estradiol used for 6 months

Group Type: ACTIVE_COMPARATOR

dorspirenone/ethynil estradiol

Intervention Type: DRUG

control

control group ( only take biopsies and blood samples )

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

treatment azelaic acid (azelan)

treatment for 6 months

Intervention Type: DRUG

dorspirenone/ethynil estradiol

Intervention Type: DRUG

Other Intervention Names

azelaic acid (azelan); (yaz)

Eligibility Criteria

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.

-

• Minimum Eligible Age: 26 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fleury

UNKNOWN

Sponsor Role: collaborator

Associacao Fundo de Incentivo a Psicofarmcologia

OTHER

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: collaborator

Marco Alexandre Dias da Rocha

OTHER

Sponsor Role: lead

Responsible Party

Marco Alexandre Dias da Rocha

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

marco rocha, md

Role: PRINCIPAL_INVESTIGATOR

UNIFESP-EPM

Locations

Federal University of São Paulo-Dermatology

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

marco rocha, md

Role: CONTACT

marcoderm@hotmail.com

55-11-55799331

Facility Contacts

marco rocha, md

Role: primary

marcoderm@hotmail.com

55-11-55799331

References

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Reference Type: BACKGROUND

PMID: 19588637 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 21710106 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 12833004 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 15556729 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 10495379 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 9039297 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11843213 (View on PubMed)

Other Identifiers

1622/11

Identifier Type: -

Identifier Source: org_study_id