TineaPhase 3DaVinciNCT02582177
Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis
A Phase 3 study testing Candicort®, Nizoral® and Baycuten N® in people with Tinea, run by Ache Laboratorios Farmaceuticos S.A. at 9 sites in Brazil.
Trial summary
To evaluate the no-inferiority of the ketoconazole20mg/g and betamethasone dipropionate 0.64 mg/g association (Candicort®) cream versus clotrimazole 10mg and dexamethasone acetate 0.443 mg/g association (Baycuten N®) cream, general relief of signs and symptoms (erythema, maceration, peeling, blistering / papules /… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tinea
- What is being tested?
- Candicort®, Nizoral® and Baycuten N®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 9 sitesBrazil
- Study dates
- 11 Jun 2019to 24 Mar 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF);
- Participants with moderate or severe clinical diagnosis of superficial mycoses caused by Candida ssp or following fungal /dermatophytosis infections: inflammatory tinea corporis inflammatory (except face), inflammatory tinea cruris and inflammatory tinea pedis, with confirmation through direct mycological examination. In moderate or severe superficial mycosis that present at least moderate erythema and itching signs and slight peeling according to the evaluation by the four-point category scale (0=absent, 1-mild, 2-moderate, 3-severe);
Who cannot join
- Any observational finding (clinical/ physical evaluation) that is interpreted by the investigator as a risk to the research participant's participation in the clinical trial;
- Known hypersensitivity to the drug components used during the study;
- Use of prohibited drugs and treatment prohibited in the last 90 days;
- Immune impairment, according to investigator assessment;
- Vulvovaginal candidiasis diagnostics, balanopreputial, nail, chronic mucocutaneous or oral;
- Diagnosis of chickenpox, rosacea, herpes simplex or zoster, skin tuberculosis or skin syphilis, systemic fungal infection;
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- Participants who, though they have studied diagnosis of fungal infections requiring systemic treatment according to the severity of injury and according to the opinion of the investigator;
- Participants that have skin lesions with clinical signs of bacterial infection;
- Participants who, according to investigator assessment, require systemic antibiotic treatment;
- Participants that are in any treatment , in the opinion of the investigator, may affect the results of the study;
- Participants diagnosed with HIV;
- Participants diagnosed with Diabetes Mellitus;
- Participants with a history of smallpox vaccine reaction;
- Women in gestation period or who are breastfeeding;
- Female participants who are in the reproductive age and do not agree to use acceptable methods of contraception (oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation); except surgically sterile (bilateral oophorectomy or hysterectomy), the menopausal for at least one year and participants who declare to perform sexual practices on a not to reproductive way;
- Participant who participated in clinical in the last twelve months, unless the investigator considers that there may be direct benefit to thereof;
- Participant has some kinship of second degree or bond with employees or employees of Sponsor and Research Center.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Brazil9 sites
Allergisa Pesquisa Dermato Cosmética Ltda.
Campinas, São Paulo
Scentryphar Pesquisa Clínica
Campinas, São Paulo
Sociedade Campineira de Educação e Instrução - Centro de Pesquisa Clínica São Lucas - PUCCAMP
Campinas, São Paulo
Centro de Pesquisa Clínica do IMIP
Recife, Pernambuco
Centro de Pesquisa Clínica - CPEC / Associação Obras Sociais Irmã Dulce
Salvador, Estado de Bahia
Centro de Estudos Multidisciplinar CEPES da Faculdade de Medicina do ABC
Santo André, São Paulo
Centro Integrado de Pesquisa - CIP
São José do Rio Preto, São Paulo
CDEC Brasil - Centro de Desenvolvimento em Estudo Clínicos Brasil / AFIP-Associação Fundo de Incentivo à pesquisa)
São Paulo
Centro de Pesquisa Clínica - HSM (Hospital Santa Marcelina)
São Paulo
About this study
Official title: Phase 3 Study, Randomized, Double-blind, Parallel to Evaluate Ketoconazole and Betamethasone Dipropionate(Candicort®) Compared to Clotrimazole and Dexamethasone Acetate(Baycuten N®) in Relief of Fungal Infections/Dermatophytosis Symptoms.
To evaluate the no-inferiority of the ketoconazole20mg/g and betamethasone dipropionate 0.64 mg/g association (Candicort®) cream versus clotrimazole 10mg and dexamethasone acetate 0.443 mg/g association (Baycuten N®) cream, general relief of signs and symptoms (erythema, maceration, peeling, blistering / papules / pustules, itching and burning / stinging) 06 (± 1) days after onset treatment.
Read the detailed description
Candicort® presents formulation with agents that act both etiological agent of superficial mycosis, with coverage for dermatophytes and more frequent yeast; as inflammation generated by the infectious process or prior to it, in cases of secondary fungal infection in wet or potentially infected eczema fungal dermatitis (atopic dermatitis, seborrhoeic dermatitis, intertrigo, dyshidrosis, contact dermatitis).
The active ingredients ketoconazole and betamethasone act, respectively, on the etiologic agent of the infection and the inflammation generated by the process, and the association of both showed a positive therapeutic response in dermatitis with confirmed secondary infections or potential yeast (analysis carried out in association with sulfate neomycin, aimed to cover bacterial infections together).
160 participants that meet all the inclusion criteria and are not classified in any of the exclusion criteria will be randomly allocated to one of two treatment groups(Candicort® or Baycuten N®) of the study.
- Conditions
- Tinea
- Being tested
- Candicort®, Nizoral®, Baycuten N®, Canesten®
- Keywords
- Fungal infection, Skin infection, Dermatophytoses
- Medical subject headings
- Tinea, Mycoses, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candicort®Drug
Also called ketoconazole and betamethasone dipropionate
Apply on the affected area and around it twice a day
Nizoral®Drug
Also called ketoconazole
Apply on the affected area and around it twice a day
Baycuten N®Drug
Also called clotrimazole and dexamethasone acetate
Apply on the affected area and around it twice a day
Canesten®Drug
Also called clotrimazole
Apply on the affected area and around it twice a day
| Study group | Role | What they receive |
|---|---|---|
| Candicort®/ Nizoral® | Experimental | Candicort® is a cream composed by ketoconazole 20mg/g and betamethasone dipropionate 0,64 mg/g that will be dispensed to 80 participants of this group in the first stage. The cream will be applied in the affected area twice a day for 14 (+1) days. In the second stage Nizoral ® will be dispensed to the same participants. It´s a cream composed by ketoconazole 20mg/g that will be applied in the affected area once a day for 14 days. The total duration of treatment may be 28 (+1) days. Receives: Drug: Candicort®; Drug: Nizoral® |
| Baycuten N®/ Canesten® | Experimental | Baycuten N® is a cream composed by clotrimazole 10mg and dexamethasone acetate 0.443 mg/g that will be dispensed to 80 participants of this group in the first stage. he cream will be applied in the affected area twice a day for 14 (+1) days. In the second stage Canesten ® will be dispensed to the same participants. It´s a cream composed by clotrimazole 10mg that will be applied in the affected area once a day for 14 days.The total duration of treatment may be 28 (+1) days. Receives: Drug: Baycuten N®; Drug: Canesten® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in the total score of signs and symptoms
Percentage change in the total score of signs and symptoms (erythema, maceration, peeling, blistering /papules /pustules, itching and burning/ stinging) in 6 (±1) days after onset first stage of treatment in relation to the basal.
The total score will be established by the sum of individual scores of the signs and symptoms assessed by the four-point categorical scale (0=absent, 1=mild, 2=moderate, 3=severe), ranging from 0 to 18 points.
The percentage change in the total score of signs and symptoms will be calculated by the following expression:
VTSS(%) = [(TSS0 -TSS6)/ TSS0]*100
TSS0: total score of signs and symptoms (erythema, maceration, peeling, blistering /papules /pustules, itching and burning/ stinging) in 0 day.
TSS6: total score of signs and symptoms (erythema, maceration, peeling, blistering /papules /pustules, itching and burning/ stinging) in 6 (±1) days after onset first stage of treatment
Measured: 6 (±1) days
Secondary outcomes (5)
Percentage change in the total score of signs and symptoms
Evaluate the percentage change in the total score of signs and symptoms (erythema, maceration, peeling, blistering /papules /pustules, itching and burning/ stinging) during the treatment, evaluated in 6 (±1) and 14 (+1) days after onset first stage of treatment in relation to the basal with the treatment group allocated (Candicort® or Baycuten N®). The total score will be established by the sum of individual scores of the signs and symptoms assessed by the four-point categorical scale (0=absent, 1=mild, 2=moderate, 3=severe), ranging from 0 to 18 points.
Measured: 6 (±1) and 14 (+1) days
Percentage change in the total score of signs and symptoms
Evaluate the percentage change in the total score of signs and symptoms (erythema, maceration, peeling, blistering /papules /pustules, itching and burning/ stinging) in 14 (+1) days after end of the treatment with antifungal isolated (Ketoconazole or Canesten®) in the second stage of treatment. The total score will be established by the sum of individual scores of the signs and symptoms assessed by the four-point categorical scale (0=absent, 1=mild, 2=moderate, 3=severe), ranging from 0 to 18 points.
Measured: Up to 1 month
Mycological cure (Negative result for the direct mycological examination)
Assess the proportion of participants who have mycological cure after completion of treatment with antifungal isolated (Ketoconazole or Canesten®) in 14 (+1) days after end of the treatment with antifungal isolated (Ketoconazole or Canesten®) in the second stage of treatment.
Measured: Up to 1 month
Participants satisfaction regarding the treatment
Assess the satisfaction of participants regarding the treatment using a Visual Analogue Scale (EVA 0 to 100mm) in 6 (±1) and 14 (+1) days after onset first stage of treatment in relation to the basal with the treatment group allocated (Candicort® or Baycuten N®).
Measured: 6 (±1) days and14 (+1) days
Participants satisfaction regarding the treatment
Assess the satisfaction of participants regarding the treatment using a Visual Analogue Scale (EVA 0 to 100mm) in 14 (+1) days after end of the treatment with antifungal isolated (Ketoconazole or Canesten®) in the second stage of treatment.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study start11 Jun 2019
- Primary completion20 Jan 2020
- Study completion24 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TineaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- André Vergnanini, Principal investigator, Allergisa Pesquisa Dermato-Cosmetica LTDA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582177
- Sponsor's protocol ID
- ACH-CND-03(05/15)
- Acronym
- DaVinci
- Status last verified
- Sep 2021
- First submitted
- 20 Oct 2015
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study, Randomized, Double-blind, Parallel to Evaluate Ketoconazole and Betamethasone Dipropionate(Candicort®) Compared to Clotrimazole and Dexamethasone Acetate(Baycuten N®) in Relief of Fungal Infections/Dermatophytosis Symptoms.
- ClinicalTrials.gov ID
- NCT02582177
- Acronym / sponsor ID
- DaVinci / ACH-CND-03(05/15)
- Conditions
- Tinea
- Keywords
- Fungal infection, Skin infection, Dermatophytoses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 21 Oct 2015 (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.
To evaluate the no-inferiority of the ketoconazole20mg/g and betamethasone dipropionate 0.64 mg/g association (Candicort®) cream versus clotrimazole 10mg and dexamethasone acetate 0.443 mg/g association (Baycuten N®) cream, general relief of signs and symptoms (erythema, maceration, peeling, blistering / papules / pustules, itching and burning / stinging) 06 (± 1) days after onset treatment.
Detailed description
Candicort® presents formulation with agents that act both etiological agent of superficial mycosis, with coverage for dermatophytes and more frequent yeast; as inflammation generated by the infectious process or prior to it, in cases of secondary fungal infection in wet or potentially infected eczema fungal dermatitis (atopic dermatitis, seborrhoeic dermatitis, intertrigo, dyshidrosis, contact dermatitis).
The active ingredients ketoconazole and betamethasone act, respectively, on the etiologic agent of the infection and the inflammation generated by the process, and the association of both showed a positive therapeutic response in dermatitis with confirmed secondary infections or potential yeast (analysis carried out in association with sulfate neomycin, aimed to cover bacterial infections together).
160 participants that meet all the inclusion criteria and are not classified in any of the exclusion criteria will be randomly allocated to one of two treatment groups(Candicort® or Baycuten N®) of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Candicort®/ Nizoral® | Experimental | Drug: Candicort®, Drug: Nizoral®Candicort® is a cream composed by ketoconazole 20mg/g and betamethasone dipropionate 0,64 mg/g that will be dispensed to 80 participants of this group in the first stage. The cream will be applied in the affected area twice a day for 14 (+1) days. In the second stage Nizoral ® will be dispensed to the same participants. It´s a cream composed by ketoconazole 20mg/g that will be applied in the affected area once a day for 14 days. The total duration of treatment may be 28 (+1) days. |
| Baycuten N®/ Canesten® | Experimental | Drug: Baycuten N®, Drug: Canesten®Baycuten N® is a cream composed by clotrimazole 10mg and dexamethasone acetate 0.443 mg/g that will be dispensed to 80 participants of this group in the first stage. he cream will be applied in the affected area twice a day for 14 (+1) days. In the second stage Canesten ® will be dispensed to the same participants. It´s a cream composed by clotrimazole 10mg that will be applied in the affected area once a day for 14 days.The total duration of treatment may be 28 (+1) days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF);
- Participants with moderate or severe clinical diagnosis of superficial mycoses caused by Candida ssp or following fungal /dermatophytosis infections: inflammatory tinea corporis inflammatory (except face), inflammatory tinea cruris and inflammatory tinea pedis, with confirmation through direct mycological examination. In moderate or severe superficial mycosis that present at least moderate erythema and itching signs and slight peeling according to the evaluation by the four-point category scale (0=absent, 1-mild, 2-moderate, 3-severe);
Key exclusion criteria (17 listed)
- Any observational finding (clinical/ physical evaluation) that is interpreted by the investigator as a risk to the research participant's participation in the clinical trial;
- Known hypersensitivity to the drug components used during the study;
- Use of prohibited drugs and treatment prohibited in the last 90 days;
- Immune impairment, according to investigator assessment;
- Vulvovaginal candidiasis diagnostics, balanopreputial, nail, chronic mucocutaneous or oral;
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 |
|---|---|---|
| Candicort®Also: ketoconazole and betamethasone dipropionateApply on the affected area and around it twice a day | Drug | Candicort®/ Nizoral® |
| Nizoral®Also: ketoconazoleApply on the affected area and around it twice a day | Drug | Candicort®/ Nizoral® |
| Baycuten N®Also: clotrimazole and dexamethasone acetateApply on the affected area and around it twice a day | Drug | Baycuten N®/ Canesten® |
| Canesten®Also: clotrimazoleApply on the affected area and around it twice a day | Drug | Baycuten N®/ Canesten® |
Primary outcome
Percentage change in the total score of signs and symptoms
Time frame: 6 (±1) days
Percentage change in the total score of signs and symptoms (erythema, maceration, peeling, blistering /papules /pustules, itching and burning/ stinging) in 6 (±1) days after onset first stage of treatment in relation to the basal. The total score will be established by the sum of individual scores of the signs and symptoms assessed by the four-point categorical scale (0=absent, 1=mild, 2=moderate, 3=severe), ranging from 0 to 18 points. The percentage change in the total score of signs and symptoms will be calculated by the following expression: VTSS(%) = [(TSS0 -TSS6)/ TSS0]*100 TSS0: total score of signs and symptoms (erythema, maceration, peeling, blistering /papules /pustules, itching and burning/ stinging) in 0 day. TSS6: total score of signs and symptoms (erythema, maceration, peeling, blistering /papules /pustules, itching and burning/ stinging) in 6 (±1) days after onset first stage of treatment
5 secondary outcomes
Percentage change in the total score of signs and symptoms
Time frame: 6 (±1) and 14 (+1) days
Percentage change in the total score of signs and symptoms
Time frame: Up to 1 month
Mycological cure (Negative result for the direct mycological examination)
Time frame: Up to 1 month
Participants satisfaction regarding the treatment
Time frame: 6 (±1) days and14 (+1) days
Participants satisfaction regarding the treatment
Time frame: Up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
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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.
André Vergnanini principal investigator
Allergisa Pesquisa Dermato-Cosmetica LTDA
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Candicort®, Nizoral® and Baycuten N® in people with Tinea, run by Ache Laboratorios Farmaceuticos S.A. at 9 sites 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 2 inclusion and 17 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: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in the total score of signs and symptoms (time frame: 6 (±1) days). 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 20 Sep 2021.