Acne VulgarisPhase 3ACNASENCT00877409
Safety and Efficacy Study of Acnase Creme in the Treatment of Acne Vulgaris I and II
A Phase 3 study testing Benzoyl Peroxide 5% and Sulphur 2% in people with Acne Vulgaris, run by Zurita Laboratorio Farmaceutico Ltda. at 1 site in Brazil.
Trial summary
The objective of this study is to establish the safety in use of the topical drug Acnase Creme and its effectiveness in treatment of acne grade I (comedones) and II (comedones, papules, pustules). Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Benzoyl Peroxide 5% and Sulphur 2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2009to Jul 2009
- Phase
- Phase 3
- 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 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 12 to 35 years;
- Oily skin with tendency to acne;
- Presence of non-inflammatory lesions and inflammatory, acne vulgaris diagnosed as grade I or II, as the following: I) Comedones - only comedones; II) Papulopustular - comedones, papules and pustules; III) Nodulocystic - comedones, papules, pustules, nodules and cysts; IV) Conglobates - severe acne, usually affects other areas of the body, out of preference, giving comedones, papules, pustules, abscesses, confluent nodules, cysts and scars.
- Agreement in compliance with the procedures of the trial and attend the clinic on certain days and times for medical evaluations and scores of injuries acne;
- Signing of the Term of Free and Informed Consent and agreement of the lowest in the case of patients between 12 and 17 years.
Who cannot join
- Pregnancy (pregnancy test by urinary indication to women voluntary of childbearing age);
- Nursing;
- Nodulocystic and Conglobates acne;
- Conditions associated hormone (tireoid disease, micropolicysts ovaries, adrenal or pituitary disorders);
- Drug use systemic corticosteroids, anticonvulsants, photo-sensibility and / or new drugs for up to 01 months before the selection;
- Use of topical therapy, systemic or physical (cleaning of the skin) for the treatment of acne at least 01 months before the selection;
Show all 14Show fewer
- History of atopic or allergic skin;
- History of hypersensitivity to Benzoyl peroxide or sulfur;
- Skin Conditions active (and / or spread) that may interfere with the outcome of the study;
- Beginning or end-use of contraceptives; (for females)
- Sunlight intense exposure until 01 months before the assessment;
- Aesthetic treatments, skin up to 01 months before the selection;
- Use of specific oily cosmetic for skin / acne and makeup, facial moisturizing, etc..;
- Use of the drug Acnase prior to inclusion in the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Medcin Instituto da Pele Ltda.
Osasco, São Paulo, 06023-000
Sergio Schalka, MD, 55-11-36546362, sergio@medcinonline.com.br
Sergio Schalka, MD
About this study
Official title: A Monocentric, Single-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of the Topical Drug Acnase Creme in the Treatment of Acne Vulgaris I and II
The objective of this study is to establish the safety in use of the topical drug Acnase Creme and its effectiveness in treatment of acne grade I (comedones) and II (comedones, papules, pustules).
Read the detailed description
The acne is a common dermatosis in dermatological practice, affects more than 80% of the population during the second and third decades of life. It is found worldwide, with no evidence of racial or ethnic differences that influence the susceptibility to its development. However there is influence of genetic factors, hormones, the use of certain drugs that may have previous or aggravate the disease.
It is an inflammatory disease of the follicle polissebáceo, which consists of large sebaceous glands, multiacinares, rudimentary hair follicle and a channel comprising a acro-infundibulum in its upper portion and an infra-infundibulum in the dermal portion.
This is a benign condition, self-limited, but can cause serious psychological problems or disfiguring scars, which can persist for the rest of life.
The initial change is a disorder of follicular epithelial differentiation, during which the cornea cells (keratinocytes) which are the follicle polissebáceo are excessively released in the lumen. The result of this event is the appearance of the precursor, microcomedão, from which the lesions of acne are developed (closed comedones, open comedones, papules, pustules and nodules). The dilation of the follicular infundibulum with the material produces a corneal comedão closed. This is the first clinically visible lesions of acne. As hyperkeratosis extends to the upper infundibulum, extended its opening, it formed the comedão open.
The pathogenesis of acne is complex and understood only in part. The follicular occlusion with adherent keratinocytes and activation of hormone secretion resulting in the formation of sebaceous microcomedão. Studies suggest that free fatty acids intrafoliculares control inflammation through chemotactic properties on leukocytes, monocytes and neutrophils. The free fatty acids may provide the primary stimulus for the retention hyperkeratosis follicularis. Moreover, tallow provides a favorable substrate for the proliferation of Propiniobacterium acnes (P. acnes). Studies suggest that P. acnes, a microaerophilic bacterium (almost anaerobic), Gram-positive, has a lipase able to hydrolyze triglycerides in sebum into free fatty acids. Therefore, these pathogens play critical role in the generation of inflammatory lesions. The P. acnes produces proteases and neuroaminidases, which may increase the permeability of the follicular epithelium. Also produce a chemotactic factor of low molecular weight that selects the polymorphonuclear leukocytes. In the process of phagocytosis of bacteria are released hydrolases, which break the integrity of the follicular wall. Subsequently, the content intrafolicular - fragments of keratin, fat, hair, and P. acnes - is expelled to the dermis.
If surface aggregation of neutrophils, as was a wheal, and with the presence of purulent secretion, a pustule. With the infiltration of inflammation deep and extensive, a nodule or cyst is produced.
Clinically, the eruption acnéica is located predominantly in the face (90%) and to a lesser extent, in the back (60%) and chest (15%). As young man, mainly affects the face, while in older, the back.
- Conditions
- Acne Vulgaris
- Being tested
- Benzoyl Peroxide 5% and Sulphur 2%, Vehicle of Acnase
- Keywords
- Acnase, Acne Vulgaris, Safety, Efficacy
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzoyl Peroxide 5% and Sulphur 2%Drug
Also called Acnase
The product will be applied topically forming a thin layer, 1 time a day (at night) throughout the area affected by lesions.
Vehicle of AcnaseDrug
Also called Control, Vehicle, Placebo
The product will be applied topically forming a thin layer, 1 time a day (at night) throughout the area affected by lesions.
| Study group | Role | What they receive |
|---|---|---|
| Acnase | Active comparator | Not described Receives: Drug: Benzoyl Peroxide 5% and Sulphur 2% |
| Vehicle | Placebo comparator | Not described Receives: Drug: Vehicle of Acnase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average clinical development of target lesions of the groups for each experimental time.
Measured: 12 weeks
Secondary outcomes (3)
Clinical evolution of the acne through the counting of inflammatory and non - inflammatory lesions.
Measured: 12 weeks
Evaluation of oily skin through the clinical evaluation with four-point scale (absent, mild, moderate, intense)
Measured: 12 weeks
Observation of occurrence and intensity of clinical parameters erythema, scaling, itching and burning through the clinical evaluation with four-point scale (absent, mild, moderate, severe).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zurita Laboratorio Farmaceutico Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sérgio Schalka, MD, Principal investigator, Medcin Instituto da Pele Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877409
- Sponsor's protocol ID
- EAA461-08/v8
- Other IDs
- EAA461-08/v8
- Acronym
- ACNASE
- Status last verified
- Apr 2009
- First submitted
- 6 Apr 2009
- Last updated
- 7 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocentric, Single-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of the Topical Drug Acnase Creme in the Treatment of Acne Vulgaris I and II
- ClinicalTrials.gov ID
- NCT00877409
- Acronym / sponsor ID
- ACNASE / EAA461-08/v8
- Conditions
- Acne Vulgaris
- Keywords
- Acnase, Acne Vulgaris, Safety, Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zurita Laboratorio Farmaceutico Ltda.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 7 Apr 2009 (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.
The objective of this study is to establish the safety in use of the topical drug Acnase Creme and its effectiveness in treatment of acne grade I (comedones) and II (comedones, papules, pustules).
Detailed description
The acne is a common dermatosis in dermatological practice, affects more than 80% of the population during the second and third decades of life. It is found worldwide, with no evidence of racial or ethnic differences that influence the susceptibility to its development. However there is influence of genetic factors, hormones, the use of certain drugs that may have previous or aggravate the disease.
It is an inflammatory disease of the follicle polissebáceo, which consists of large sebaceous glands, multiacinares, rudimentary hair follicle and a channel comprising a acro-infundibulum in its upper portion and an infra-infundibulum in the dermal portion.
This is a benign condition, self-limited, but can cause serious psychological problems or disfiguring scars, which can persist for the rest of life.
The initial change is a disorder of follicular epithelial differentiation, during which the cornea cells (keratinocytes) which are the follicle polissebáceo are excessively released in the lumen. The result of this event is the appearance of the precursor, microcomedão, from which the lesions of acne are developed (closed comedones, open comedones, papules, pustules and nodules). The dilation of the follicular infundibulum with the material produces a corneal comedão closed. This is the first clinically visible lesions of acne. As hyperkeratosis extends to the upper infundibulum, extended its opening, it formed the comedão open.
The pathogenesis of acne is complex and understood only in part. The follicular occlusion with adherent keratinocytes and activation of hormone secretion resulting in the formation of sebaceous microcomedão. Studies suggest that free fatty acids intrafoliculares control inflammation through chemotactic properties on leukocytes, monocytes and neutrophils. The free fatty acids may provide the primary stimulus for the retention hyperkeratosis follicularis. Moreover, tallow provides a favorable substrate for the proliferation of Propiniobacterium acnes (P. acnes). Studies suggest that P. acnes, a microaerophilic bacterium (almost anaerobic), Gram-positive, has a lipase able to hydrolyze triglycerides in sebum into free fatty acids. Therefore, these pathogens play critical role in the generation of inflammatory lesions. The P. acnes produces proteases and neuroaminidases, which may increase the permeability of the follicular epithelium. Also produce a chemotactic factor of low molecular weight that selects the polymorphonuclear leukocytes. In the process of phagocytosis of bacteria are released hydrolases, which break the integrity of the follicular wall. Subsequently, the content intrafolicular - fragments of keratin, fat, hair, and P. acnes - is expelled to the dermis.
If surface aggregation of neutrophils, as was a wheal, and with the presence of purulent secretion, a pustule. With the infiltration of inflammation deep and extensive, a nodule or cyst is produced.
Clinically, the eruption acnéica is located predominantly in the face (90%) and to a lesser extent, in the back (60%) and chest (15%). As young man, mainly affects the face, while in older, the back.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acnase | Active comparator | Drug: Benzoyl Peroxide 5% and Sulphur 2% |
| Vehicle | Placebo comparator | Drug: Vehicle of Acnase |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age: 12 to 35 years;
- Oily skin with tendency to acne;
- Presence of non-inflammatory lesions and inflammatory, acne vulgaris diagnosed as grade I or II, as the following: I) Comedones - only comedones; II) Papulopustular - comedones, papules and pustules; III) Nodulocystic - comedones, papules, pustules, nodules and cysts; IV) Conglobates - severe acne, usually affects other areas of the body, out of preference, giving comedones, papules, pustules, abscesses, confluent nodules, cysts and scars.
- Agreement in compliance with the procedures of the trial and attend the clinic on certain days and times for medical evaluations and scores of injuries acne;
- Signing of the Term of Free and Informed Consent and agreement of the lowest in the case of patients between 12 and 17 years.
Key exclusion criteria (14 listed)
- Pregnancy (pregnancy test by urinary indication to women voluntary of childbearing age);
- Nursing;
- Nodulocystic and Conglobates acne;
- Conditions associated hormone (tireoid disease, micropolicysts ovaries, adrenal or pituitary disorders);
- Drug use systemic corticosteroids, anticonvulsants, photo-sensibility and / or new drugs for up to 01 months before the selection;
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 |
|---|---|---|
| Benzoyl Peroxide 5% and Sulphur 2%Also: AcnaseThe product will be applied topically forming a thin layer, 1 time a day (at night) throughout the area affected by lesions. | Drug | Acnase |
| Vehicle of AcnaseAlso: Control, Vehicle, PlaceboThe product will be applied topically forming a thin layer, 1 time a day (at night) throughout the area affected by lesions. | Drug | Vehicle |
Primary outcome
Average clinical development of target lesions of the groups for each experimental time.
Time frame: 12 weeks
3 secondary outcomes
Clinical evolution of the acne through the counting of inflammatory and non - inflammatory lesions.
Time frame: 12 weeks
Evaluation of oily skin through the clinical evaluation with four-point scale (absent, mild, moderate, intense)
Time frame: 12 weeks
Observation of occurrence and intensity of clinical parameters erythema, scaling, itching and burning through the clinical evaluation with four-point scale (absent, mild, moderate, severe).
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2009.
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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.
Sérgio Schalka, MD principal investigator
Medcin Instituto da Pele Ltda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Benzoyl Peroxide 5% and Sulphur 2% in people with Acne Vulgaris, run by Zurita Laboratorio Farmaceutico Ltda. 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 5 inclusion and 14 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 7 Apr 2009. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sergio Schalka, MD (55-11-36546362, sergio@medcinonline.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average clinical development of target lesions of the groups for each experimental time. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2009.