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This is a multi-center, randomised and controlled study in subjects with acne vulgaris. The main objective of this study is to evaluate the effect of a supplementary patient education intervention (in addition to the standard-of-care patient education) on treatment adherence and satisfaction among acne patients receiving once-daily EpiduoTM gel treatment in primary care clinics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care + supplementary education | Experimental | Subjects will receive supplementary patient educational material in addition to standard-of-care instructions. |
|
| Standard of care | Experimental | Subjects will receive standard-of-care instructions only. |
|
| Standard of care + additional visits | Experimental | Subjects will receive standard-of-care instructions, and two additional clinical visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care + supplementary education | Behavioral |
| ||
| Standard of care + additional visits |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS) | To prevent bias, treatment adherence was assessed without subject's knowledge using a Medication Event Monitoring System (MEMS). The treatment was placed in a container fitted with a MEMS cap which recorded the time/date every time it was opened and/or closed. A day with at least one opening was considered a day the subject was adherent. Mean rate of adherence in % corresponds to the number of days the subject was adherent dividided by the total number of days of the study (84 days) times 100. Analysis was performed on the "worst-case" population: Missing data were considered as non-adherence. | week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swan Lane Medical Centre | Bolton | United Kingdom | ||||
| Burbage Surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29027127 | Derived | Myhill T, Coulson W, Nixon P, Royal S, McCormack T, Kerrouche N. Use of Supplementary Patient Education Material Increases Treatment Adherence and Satisfaction Among Acne Patients Receiving Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in Primary Care Clinics: A Multicenter, Randomized, Controlled Clinical Study. Dermatol Ther (Heidelb). 2017 Dec;7(4):515-524. doi: 10.1007/s13555-017-0203-4. Epub 2017 Oct 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care + Supplementary Education | Subjects received supplementary patient educational material in addition to standard-of-care instructions. |
| FG001 | Standard of Care | Subjects received standard-of-care instructions only. |
| FG002 | Standard of Care + Additional Visits | Subjects received standard-of-care instructions, and two additional clinical visits. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care + Supplementary Education | Subjects received supplementary patient educational material in addition to standard-of-care instructions. |
| BG001 | Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS) | To prevent bias, treatment adherence was assessed without subject's knowledge using a Medication Event Monitoring System (MEMS). The treatment was placed in a container fitted with a MEMS cap which recorded the time/date every time it was opened and/or closed. A day with at least one opening was considered a day the subject was adherent. Mean rate of adherence in % corresponds to the number of days the subject was adherent dividided by the total number of days of the study (84 days) times 100. Analysis was performed on the "worst-case" population: Missing data were considered as non-adherence. | Only subjects with usable MEMS data were analyzed, therefore the number of subjects in the analysis population is not the full population. | Posted | Mean | Standard Deviation | percentage of adherence | week 12 |
|
12 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 | Standard of Care + Supplementary Education | Subjects received supplementary patient educational material in addition to standard-of-care instructions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gaëlle Charier | Galderma | +33 4 93 95 70 68 | gaelle.charier@galderma.com |
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| 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 |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Behavioral |
|
| Standard of care | Behavioral |
|
| Burbage |
| United Kingdom |
| South Axholme Practice | Epworth | United Kingdom |
| Dr Moss and Partners | Harrogate | United Kingdom |
| Barlow Medical Centre | Manchester | United Kingdom |
| Leicester Terrace Health Care Centre | Northampton | United Kingdom |
| University of Nottingham Health Service | Nottingham | United Kingdom |
| Rothwell and Desborough Healthcare Group | Rothwell | United Kingdom |
| Albany House Medical Centre | Wellingborough | United Kingdom |
| Whitby Group Practice | Whitby | United Kingdom |
| Lost to Follow-up |
|
Subjects received standard-of-care instructions only.
| BG002 | Standard of Care + Additional Visits | Subjects received standard-of-care instructions, and two additional clinical visits. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Skin Phototype | Type I: never tan; always sunburn if exposed to sunlight, primarily read headed and lighty complected blondes Type II: frequently burn but are able to tan to a small degree after extended exposure Type III: burn infrequently; tan readily Type IV: rarely burn, tan heavily with moderate sun exposure; esp. Asian, American Indian, Mediterranean and Latin American. Type V: have dark constitutive pigmentation, become darker with sun exposure, esp. light complected black individuals, Indian descent. Type VI: have the heaviest constitutive pigmentation, esp. dark skinned black individuals. | Number | participants |
|
| Investigator Global Assessment of Acne | Clear: Residual hyperpigmentation and erythema may be present Almost clear: a few scattered comedones and a few small papules Mild: Some comedones and some papules and pustules. No nodules present. Moderate: Many comedones, papules and pustules. One nodule may be present. Severe: Covered with comedones, numerous papules and pustules and few nodules may be present. Very severe: Highly inflammatory acne covering the face, with nodules present. | Number | participants |
|
| Acne History | Duration in years | Number | participants |
|
Subjects received supplementary patient educational material in addition to standard-of-care instructions.
| OG001 | Standard of Care | Subjects received standard-of-care instructions only. |
| OG002 | Standard of Care + Additional Visits | Subjects received standard-of-care instructions, and two additional clinical visits. |
|
|
|
| 0 |
| 33 |
| 7 |
| 33 |
| EG001 | Standard of Care | Subjects received standard-of-care instructions only. | 0 | 33 | 6 | 33 |
| EG002 | Standard of Care + Additional Visits | Subjects received standard-of-care instructions, and two additional clinical visits. | 0 | 31 | 15 | 31 |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
Disclosure agreement covered by contract.