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This is a multicenter open-label, prospective study in subjects with dark skin from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American and with moderate to severe acne vulgaris on the face.
All eligible subjects will receive Adapalene 0.3% - BPO 2.5% gel (Epiduo Forte/TactuPump Forte) once daily on whole face.
The purpose of this trial is to evaluate subject reported outcomes with the combination of Adapalene 0.3% - BPO 2.5%, Epiduo Forte / TactuPump Forte gel, after 16 weeks of treatment of moderate to severe acne in dark skin phototypes (IV to VI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapalene / BPO gel | Experimental | Adapalene 0.3% / BPO 2.5% gel, once daily in the evening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene 0.3% / BPO 2.5% gel | Drug | Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire | % of subjects satisfied to very satisfied with study treatment at week 12 | At week 12 |
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Inclusion Criteria:
Subject with clinical diagnosis of moderate to severe facial acne vulgaris, defined by:
Subject with skin phototype IV to VI on Fitzpatrick skin phototype scale,
Subjects from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American,
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermresearch | Austin | Texas | 78759 | United States | ||
| CIDP |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31251543 | Derived | DuBois J, Ong GCW, Petkar G, Almeida LMC, Chavda R, Kerrouche N, Alexis AF. Patient-Reported Outcomes in Acne Patients With Skin of Color Using Adapalene 0.3%-Benzoyl Peroxide 2.5%: A Prospective Real-World Study. J Drugs Dermatol. 2019 Jun 1;18(5):514. |
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Wash-out period for topical treatment or procedures of 1 week to 3 months and for systemic treatment for 1 month to 3 months, depending on treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | Adapalene / BPO Gel | Adapalene 0.3% / BPO 2.5% gel, once daily in the evening Adapalene 0.3% / BPO 2.5% gel: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | Adapalene / BPO Gel | Adapalene 0.3% / BPO 2.5% gel, once daily in the evening Adapalene 0.3% / BPO 2.5% gel: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire | % of subjects satisfied to very satisfied with study treatment at week 12 | Intent-to-treat (ITT) population. Here 'N' (number analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At week 12 |
|
|
Up to 16 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adapalene / BPO Gel | Adapalene 0.3% / BPO 2.5% gel, once daily in the evening Adapalene 0.3% / BPO 2.5% gel: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rajeev Chavda | Galderma | 0033 | 492382928 | rajeev.chavda@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Version for USA | Mar 23, 2017 | Oct 31, 2019 | Prot_SAP_000.pdf |
| 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 |
| D005782 | Gels |
| D000068801 | Adapalene, Benzoyl Peroxide Drug Combination |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Phoenix |
| Mauritius |
| CIDP | Singapore | Singapore |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Skin phototype | Fitzpatrick skin phototype is a system used to describe a person's skin type. It ranges from skin phototype I to VI. Where, skin phototype I = pale white skin, always burns easily, never tans; skin phototype II = fair skin, always burns easily, tans minimally and with difficulty; skin phototype III = darker white skin, burns minimally, tans gradually and uniformly; skin phototype IV = light brown skin, burns minimally, always tans well; skin phototype V = brown skin, rarely burns, tans profusely; skin phototype VI = dark brown or black skin, never burns, tans profusely. | Count of Participants | Participants |
|
| Participants |
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 9 |
| 50 |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Post inflammatory pigmentation change | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
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| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D001585 | Benzoyl Peroxide |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D004338 | Drug Combinations |