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Due to budget limitations, the company decided to withdraw this study.
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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®.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene and Benzoyl peroxide Dalap Duo® | Drug |
| ||
| Adapalene and Benzoyl peroxide Epiduo® |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of number of inflammatory lesions | 07, 14, 28, 56 and 84 days | |
| Reduction in non-inflammatory lesions | 07, 14, 28, 56 and 84 days | |
| Improvement of acne through Global assessment of investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| 07, 14, 28, 56 and 84 days |
| Efficiency perceived by participant | 84 days |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D000068816 | Adapalene |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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