The Influence of Peripheral Androgen Conversion at Women Adult Acne

Not Applicable

• Conditions: Acne; Quality of Life
• Interventions: Drug: treatment azelaic acid (azelan); Drug: dorspirenone/ethynil estradiol

• Registration Number: NCT01850095
• Lead Sponsor: Marco Alexandre Dias da Rocha

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 available

Study Timeline

• Study Start: 2012-03
• Status Verified: 2013-05
• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-05-08
• Last Update Submitted: 2013-05-08
• Study First Posted: 2013-05-09
• Last Update Posted: 2013-05-09
• Primary Completion: 2013-06
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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:

2. Smokers over 35 years;

3. history of deep venous thrombosis;

4. history of stroke;

5. history of breast cancer;

6. presence of jaundice, and severe active liver disease or biliary disease;

7. diabetes mellitus for more than 20 years or eye injury, or neurological impairment;

8. blood pressure greater than or equal to 160 to 100 for systolic and diastolic;

9. cardiovascular disease and

10. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment 1	treatment azelaic acid (azelan)	topical acid azelaic, used 2 times a day for 6 months
treatment 2	dorspirenone/ethynil estradiol	contraceptive with drospirenone/ethinyl estradiol used for 6 months

Primary Outcome Measures

Name	Time	Method
Clinical evaluation of the treatment group	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.

Secondary Outcome Measures

Name	Time	Method
Photographic study of the treatment group	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.

Trial Locations

Locations (1)

Federal University of São Paulo-Dermatology; 🇧🇷 são Paulo, Brazil