AcneNCT01850095
The Influence of Peripheral Androgen Conversion at Women Adult Acne
A study testing treatment azelaic acid (azelan) and dorspirenone/ethynil estradiol in people with Acne and Quality of Life, run by Marco Alexandre Dias da Rocha at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acne, Quality of Life
- What is being tested?
- treatment azelaic acid (azelan) and dorspirenone/ethynil estradiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- acnogenics cosmetics.
- For the group treated with oral contraceptives:
- 1. 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;
- blood pressure greater than or equal to 160 to 100 for systolic and diastolic;
- cardiovascular disease and
- 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.
- -
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of São Paulo-Dermatology
São Paulo, São Paulo, 04038-001
marco rocha, md, 55-11-55799331, marcoderm@hotmail.com
marco rocha, md
About this study
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.
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
- Being tested
- treatment azelaic acid (azelan), dorspirenone/ethynil estradiol
- Keywords
- acne, adult, women, TLR, CD1d, androgens
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment azelaic acid (azelan)Drug
Also called azelaic acid (azelan)
treatment for 6 months
dorspirenone/ethynil estradiolDrug
Also called (yaz)
| Study group | Role | What they receive |
|---|---|---|
| treatment 1 | Active comparator | topical acid azelaic, used 2 times a day for 6 months Receives: Drug: treatment azelaic acid (azelan) |
| treatment 2 | Active comparator | contraceptive with drospirenone/ethinyl estradiol used for 6 months Receives: Drug: dorspirenone/ethynil estradiol |
| control | No intervention | control group ( only take biopsies and blood samples ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startMar 2012
- Primary completionJun 2013 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marco Alexandre Dias da Rocha
- Sponsor type
- University, hospital or other
- Collaborators
- Fleury, Associacao Fundo de Incentivo a Psicofarmcologia, Bayer
- Responsible party
- Sponsor-investigator, Marco Alexandre Dias da Rocha, Federal University of São Paulo
- Investigators
- marco rocha, md, Principal investigator, UNIFESP-EPM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850095
- Sponsor's protocol ID
- 1622/11
- Status last verified
- May 2013
- First submitted
- 1 May 2013
- Last updated
- 9 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bhambri S, Del Rosso JQ, Bhambri A. Pathogenesis of acne vulgaris: recent advances. J Drugs Dermatol. 2009 Jul;8(7):615-8.
PubMed 19588637Shen 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.
PubMed 21710106Gollnick 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.
PubMed 12833004Thiboutot D. Acne: hormonal concepts and therapy. Clin Dermatol. 2004 Sep-Oct;22(5):419-28. doi: 10.1016/j.clindermatol.2004.03.010.
PubMed 15556729Kurokawa 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.
PubMed 19555434White 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.
PubMed 9703121Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999 Oct;41(4):577-80.
PubMed 10495379Goulden V, Clark SM, Cunliffe WJ. Post-adolescent acne: a review of clinical features. Br J Dermatol. 1997 Jan;136(1):66-70.
PubMed 9039297Poli 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.
PubMed 11843213
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01850095
- Acronym / sponsor ID
- 1622/11
- Conditions
- Acne, Quality of Life
- Keywords
- acne, adult, women, TLR, CD1d, androgens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marco Alexandre Dias da RochaUniversity, hospital or other
- Collaborators
- Fleury, Associacao Fundo de Incentivo a Psicofarmcologia, Bayer
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 9 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| treatment 1 | Active comparator | Drug: treatment azelaic acid (azelan)topical acid azelaic, used 2 times a day for 6 months |
| treatment 2 | Active comparator | Drug: dorspirenone/ethynil estradiolcontraceptive with drospirenone/ethinyl estradiol used for 6 months |
| control | No intervention | –control group ( only take biopsies and blood samples ) |
Who may qualify
- Ages
- 26 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treatment azelaic acid (azelan)Also: azelaic acid (azelan)treatment for 6 months | Drug | treatment 1 |
| dorspirenone/ethynil estradiolAlso: (yaz) | Drug | treatment 2 |
Primary outcome
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.
1 secondary outcome
Photographic study of the treatment group
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2013.
- Background: PubMed 19588637Bhambri S, Del Rosso JQ, Bhambri A. Pathogenesis of acne vulgaris: recent advances. J Drugs Dermatol. 2009 Jul;8(7):615-8.
- Background: PubMed 21710106Shen 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.
- Background: PubMed 12833004Gollnick 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.
- Background: PubMed 15556729Thiboutot D. Acne: hormonal concepts and therapy. Clin Dermatol. 2004 Sep-Oct;22(5):419-28. doi: 10.1016/j.clindermatol.2004.03.010.
- Background: PubMed 19555434Kurokawa 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.
- Background: PubMed 9703121White 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.
- Background: PubMed 10495379Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999 Oct;41(4):577-80.
- Background: PubMed 9039297Goulden V, Clark SM, Cunliffe WJ. Post-adolescent acne: a review of clinical features. Br J Dermatol. 1997 Jan;136(1):66-70.
- Background: PubMed 11843213Poli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
marco rocha, md principal investigator
UNIFESP-EPM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment azelaic acid (azelan) and dorspirenone/ethynil estradiol in people with Acne and Quality of Life, run by Marco Alexandre Dias da Rocha at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact marco rocha, md (55-11-55799331, marcoderm@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of the treatment group (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01850095, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2013.