Acne VulgarisPhase 3NarcisoNCT02716090
Clinical Trial Phase III to Assess the Non-inferiority of Dalap Duo® Product Compared to Epiduo® in the Treatment of Acne Vulgaris
A Phase 3 study testing Adapalene and Benzoyl peroxide Dalap Duo® and Adapalene and Benzoyl peroxide Epiduo® in people with Acne Vulgaris, run by Ache Laboratorios Farmaceuticos S.A..
Trial summary
This study evaluates the non-inferiority of the product Dalap Duo® compared to Epiduo® medicine to treat acne. Half of the participants will receive Dalap Duo®, while the other half will receive Epiduo®. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Adapalene and Benzoyl peroxide Dalap Duo® and Adapalene and Benzoyl peroxide Epiduo®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Nov 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- female or male Participant
- Age older than or equal to 12 years;
- 30-100 non-inflammatory facial lesions, except in the nose region (comedo closed and open comedo - degree 1) and 20 to 50 inflammatory facial lesions, except in the nose region (papule and pustule - degree 2);
- Ability to understand and consent to participate in this clinical study, expressed by signing the consent form;
- Search Participant willing to not use, for the entire period of the study drugs, cosmetics and / or treatments for acne, according to the investigator, that may influence the study results, such as, but not limited to, treatment with oral and topical retinoids.
Who cannot join
- Any finding of clinical observation (clinical assessment / physical) that is interpreted by the investigator as a risk to safety or which may interfere with the effectiveness of the treatment and research of the participants in the clinical trial;
- Any laboratory examination found that the investigator consider as safety risk or that may interfere with the effectiveness of the treatment and research of the participants in the clinical trial;
- Known hypersensitivity to the drug components used during the study;
- female participants with a history of polycystic ovary syndrome (Stein-Leventhal syndrome);
- Women with positive result for urinary beta human chorionic gonadotropin or gestation period or breastfeeding;
- Women in the reproductive age who do not agree to use acceptable contraception [oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation]; other than surgically sterile (bilateral oophorectomy or hysterectomy) or sexual abstinence or who have not yet initiated sexual activity;
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- Person who has participated in clinical trial protocols in the last twelve (12) months, unless the investigator considers that there may be direct benefit to him/her;
- Participant who has some kinship to the second degree or bond with employees or employees of Sponsor and Research Center;
- Women in menopausal or postmenopausal period;
- Any feature in the test areas (face) that according to the investigator may influence the results, for example, BUT NOT LIMITED TO moles, tattoos, scars, irritated skin, scratches, cuts and excess hair;
- Participants diagnosed with Diabetes Mellitus after evaluation of the result of the test, defined as the presence of the classic symptoms of diabetes mellitus assessed the visit V-1 associated with the higher level of casual plasma glucose or equal to 200 mg / dL according to the American Diabetes Association (DIABETES CARE, VOLUME 33, SUPPLEMENT 1, JANUARY 2010);
- Presence of dermatoses related to diabetes mellitus (plantar ulcer, necrobiosis lipoid, annular granuloma, dermatophytosis, deep mycoses, bacterial infections, opportunistic infections);
- immune impairment;
- Dermatological diseases in the test area (face): vitiligo, psoriasis, atopic dermatitis;
- Participant using topical treatment for acne in the 15 days preceding the screening visit (V-1) or oral treatment for acne in the 30 days preceding the screening visit (V-1) or plan to use during the study period;
- Participant with cyst or lump in the face region;
- Use of medication and / or treatment contrary as described in item 11.2. of the Protocol;
- Other diseases or medications, according to the investigator, that would interfere directly in the results of the study or jeopardize the health of the participant.
About this study
Official title: National Clinical Trial, Phase III, Monocentric, Randomized, Open, Controlled, Parallel Study to Assess the Non-inferiority of Dalap Duo® Product (0,1% Adapalene and 2,5% Benzoyl Peroxide Gel Cream) Compared to Epiduo® (0,1% Adapalene and 2,5% Benzoyl Peroxide Gel) in the Treatment of Acne Vulgaris in Population of Men and Women
This study evaluates the non-inferiority of the product Dalap Duo® compared to Epiduo® medicine to treat acne. Half of the participants will receive Dalap Duo®, while the other half will receive Epiduo®.
Read the detailed description
The investigational product produced by Aché that will be evaluated in this trial is a cream gel, comprising 0.1% of adapalene 2.5% and benzoyl peroxide. It's a topical cream gel that is stored on a laminated tube containing 30 grams.
Of the 376 research participants with acne vulgaris participating in the study, 188 will be treated with the investigational product Cream Gel.
The duration of the participants in the study will be up to one hundred twenty-four days, contemplating screening visit, randomization visit, four follow-up visits, a final visit and a phone contact 30 days after final visit. Of the one hundred twenty and fourth days of the study period, the participants will be treated for eighty four days.
Regarding the control group, the active comparator is Epiduo®, manufactured by Galderma Laboratories, and its formulation is composed of 0.1% adapalene 2.5% and benzoyl peroxide. This is a topical gel stored in laminated tube with 30 grams.
Of the 376 research participants with acne vulgaris that will participate in the study, 188 will be treated with the active comparator Epiduo®.
The duration of the participants in the study will be up to one hundred twenty-four days, contemplating screening visit, randomization visit, four follow-up visits, a final visit and a phone contact 30 days after final visit. Of One hundred twenty and fourth days of the study period, the participants will be treated for eighty four days.
- Conditions
- Acne Vulgaris
- Being tested
- Adapalene and Benzoyl peroxide Dalap Duo®, Adapalene and Benzoyl peroxide Epiduo®
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapalene and Benzoyl peroxide Dalap Duo®Drug
Adapalene and Benzoyl peroxide Epiduo®Drug
| Study group | Role | What they receive |
|---|---|---|
| Dalap Duo® | Experimental | 0.1% of adapalene and 2.5% and benzoyl peroxide gel cream. Apply the product on the areas affected by acne once a day in the evening for 84 days. Receives: Drug: Adapalene and Benzoyl peroxide Dalap Duo® |
| Epiduo® | Active comparator | 0.1% of adapalene and 2.5% and benzoyl peroxide gel. Apply the product on the areas affected by acne once a day in the evening for 84 days. Receives: Drug: Adapalene and Benzoyl peroxide Epiduo® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of total acne lesion
Percentage reduction of total acne lesion on the face other than the region of the nose by manual counting performed by the investigator.
Measured: 84 days
Secondary outcomes (4)
Reduction of number of inflammatory lesions
Measured: 07, 14, 28, 56 and 84 days
Reduction in non-inflammatory lesions
Measured: 07, 14, 28, 56 and 84 days
Improvement of acne through Global assessment of investigator
Measured: 07, 14, 28, 56 and 84 days
Efficiency perceived by participant
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Primary completionNov 2015 (estimated)
Why it stopped: Due to budget limitations, the company decided to withdraw this study.
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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716090
- Sponsor's protocol ID
- ACH-DLP-03(01/13)
- Acronym
- Narciso
- Status last verified
- Feb 2017
- First submitted
- 15 Jan 2015
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Clinical Trial, Phase III, Monocentric, Randomized, Open, Controlled, Parallel Study to Assess the Non-inferiority of Dalap Duo® Product (0,1% Adapalene and 2,5% Benzoyl Peroxide Gel Cream) Compared to Epiduo® (0,1% Adapalene and 2,5% Benzoyl Peroxide Gel) in the Treatment of Acne Vulgaris in Population of Men and Women
- ClinicalTrials.gov ID
- NCT02716090
- Acronym / sponsor ID
- Narciso / ACH-DLP-03(01/13)
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to budget limitations, the company decided to withdraw this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Primary completion
- Nov 2015 (estimated)
- First posted
- 23 Mar 2016 (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.
This study evaluates the non-inferiority of the product Dalap Duo® compared to Epiduo® medicine to treat acne. Half of the participants will receive Dalap Duo®, while the other half will receive Epiduo®.
Detailed description
The investigational product produced by Aché that will be evaluated in this trial is a cream gel, comprising 0.1% of adapalene 2.5% and benzoyl peroxide. It's a topical cream gel that is stored on a laminated tube containing 30 grams.
Of the 376 research participants with acne vulgaris participating in the study, 188 will be treated with the investigational product Cream Gel.
The duration of the participants in the study will be up to one hundred twenty-four days, contemplating screening visit, randomization visit, four follow-up visits, a final visit and a phone contact 30 days after final visit. Of the one hundred twenty and fourth days of the study period, the participants will be treated for eighty four days.
Regarding the control group, the active comparator is Epiduo®, manufactured by Galderma Laboratories, and its formulation is composed of 0.1% adapalene 2.5% and benzoyl peroxide. This is a topical gel stored in laminated tube with 30 grams.
Of the 376 research participants with acne vulgaris that will participate in the study, 188 will be treated with the active comparator Epiduo®.
The duration of the participants in the study will be up to one hundred twenty-four days, contemplating screening visit, randomization visit, four follow-up visits, a final visit and a phone contact 30 days after final visit. Of One hundred twenty and fourth days of the study period, the participants will be treated for eighty four days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dalap Duo® | Experimental | Drug: Adapalene and Benzoyl peroxide Dalap Duo®0.1% of adapalene and 2.5% and benzoyl peroxide gel cream. Apply the product on the areas affected by acne once a day in the evening for 84 days. |
| Epiduo® | Active comparator | Drug: Adapalene and Benzoyl peroxide Epiduo®0.1% of adapalene and 2.5% and benzoyl peroxide gel. Apply the product on the areas affected by acne once a day in the evening for 84 days. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- female or male Participant
- Age older than or equal to 12 years;
- 30-100 non-inflammatory facial lesions, except in the nose region (comedo closed and open comedo - degree 1) and 20 to 50 inflammatory facial lesions, except in the nose region (papule and pustule - degree 2);
- Ability to understand and consent to participate in this clinical study, expressed by signing the consent form;
- Search Participant willing to not use, for the entire period of the study drugs, cosmetics and / or treatments for acne, according to the investigator, that may influence the study results, such as, but not limited to, treatment with oral and topical retinoids.
Key exclusion criteria (18 listed)
- Any finding of clinical observation (clinical assessment / physical) that is interpreted by the investigator as a risk to safety or which may interfere with the effectiveness of the treatment and research of the participants in the clinical trial;
- Any laboratory examination found that the investigator consider as safety risk or that may interfere with the effectiveness of the treatment and research of the participants in the clinical trial;
- Known hypersensitivity to the drug components used during the study;
- female participants with a history of polycystic ovary syndrome (Stein-Leventhal syndrome);
- Women with positive result for urinary beta human chorionic gonadotropin or gestation period or breastfeeding;
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 |
|---|---|---|
| Adapalene and Benzoyl peroxide Dalap Duo® | Drug | Dalap Duo® |
| Adapalene and Benzoyl peroxide Epiduo® | Drug | Epiduo® |
Primary outcome
Reduction of total acne lesion
Time frame: 84 days
Percentage reduction of total acne lesion on the face other than the region of the nose by manual counting performed by the investigator.
4 secondary outcomes
Reduction of number of inflammatory lesions
Time frame: 07, 14, 28, 56 and 84 days
Reduction in non-inflammatory lesions
Time frame: 07, 14, 28, 56 and 84 days
Improvement of acne through Global assessment of investigator
Time frame: 07, 14, 28, 56 and 84 days
Efficiency perceived by participant
Time frame: 84 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adapalene and Benzoyl peroxide Dalap Duo® and Adapalene and Benzoyl peroxide Epiduo® in people with Acne Vulgaris, run by Ache Laboratorios Farmaceuticos S.A..
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 18 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: withdrawn, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Reduction of total acne lesion (time frame: 84 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 15 Feb 2017.