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| Name | Class |
|---|---|
| Proinnovera GmbH | INDUSTRY |
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The aim of this study is to evaluate a complete acne regimen consisting of a medication (Benzaknen® 5% Gel), and 2 cosmetic products Dermotivin® Soft Liquid soap and Cetaphil® Dermacontrol Moisturizer SPF30 in patients with acne.
The main objective of this study is to evaluate subject satisfaction with the treatment regimen comprising Benzaknen® 5% Gel in association with 2 cosmetic products including a foam soap, Dermotivin® Soft Liquid soap, and a non comedogenic moisturizer, Cetaphil® Dermacontrol Moisturizer SPF30, in patients with mild to moderate acne, after 12 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benzaknen treatment regimen | Experimental | Benzac® 5% Gel (once daily) + Dermotivin® Soft Liquid soap (twice daily) + Cetaphil® Dermacontrol Moisturizer SPF30 (once daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benzoyl Peroxide | Drug |
| ||
| Dermotivin® Soft Liquid cleanser |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Satisfied and Very Satisfied With Regimen | Number of subjects satisfied and very satisfied with the three-part treatment regimen | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mi-Ran EGBERT, MD | Proinnovera GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EGBERT Mi-Ran | Münster | 48159 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28678647 | Derived | Kim MR, Kerrouche N. Combination of benzoyl peroxide 5% gel with liquid cleanser and moisturizer SPF 30 in acne treatment results in high levels of subject satisfaction, good adherence and favorable tolerability. J Dermatolog Treat. 2018 Feb;29(1):49-54. doi: 10.1080/09546634.2017.1342758. Epub 2017 Jul 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Three-part Treatment Regimen | Subject received a treatment regimen comprising Benzaknen® 5% Gel in association with Dermotivin® Soft Liquid cleanser and Cetaphil® Dermacontrol Moisturizer SPF30 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-Treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | Three-part Treatment Regimen | Subject received a treatment regimen comprising Benzaknen® 5% Gel in association with Dermotivin® Soft Liquid cleanser and Cetaphil® Dermacontrol Moisturizer SPF30 |
| 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 | Number of Participants Satisfied and Very Satisfied With Regimen | Number of subjects satisfied and very satisfied with the three-part treatment regimen | Only Data Observed: All subjects that answered this question (which explains the discrepancy with the total number of participants) - | Posted | Number | participants | 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 | Three-part Treatment Regimen | Subjects treated with the three-part treatment regimen comprising Benzaknen® 5% Gel in association with Dermotivin® Soft Liquid cleanser and Cetaphil® Dermacontrol Moisturizer SPF30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Leclerc | Galderma R&D | 492386706 | +33 | stephanie.leclerc@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 |
|---|---|
| D001585 | Benzoyl Peroxide |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Other |
|
| Cetaphil® Dermacontrol Moisturizer SPF30 | Other |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Skin phototype | Skin phototype definitions according to T.B. Fitzpatrick. This was assessed by the investigator at baseline I: Always burns easily; never tans II: Always burns easily; tans minimally and with difficulty III:Burns minimally; tans gradually and uniformly (light brown) IV: Burns minimally; always tans well (moderate brown) V: Rarely burns; tans profusely (dark brown) VI: Never burns; deeply pigmented (black), tans profusely | Count of Participants | Participants |
|
| Investigator Global Assessment | IGA scale: 0: Clear - Residual hyperpigmentation and erythema may be present
| Count of Participants | Participants |
|
| Acne duration | Mean | Standard Deviation | Years |
|
| Total lesion count | Mean | Standard Deviation | Lesion |
|
| Non-Inflammatory lesions | Definitions (assessment doned by trained investigator): Non-Inflammatory Lesions
Inflammatory Lesions
| Mean | Standard Deviation | Lesions |
|
| Inflammatory lesions | Mean | Standard Deviation | Lesions |
|
| Participants |
|
|
| 0 |
| 50 |
| 1 |
| 50 |
| 13 |
| 50 |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Blepharitis | Immune system disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | Non-systematic Assessment |
|
| Mucosal infection | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
|
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |