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The purpose of this study is to assess the efficacy and safety of Adapalene Gel 0.3% in the treatment of atrophic acne scars.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Differin 0.3% | Experimental | Differin® 0.3% Gel Adapalene 0.3% Topical to the face, once daily application in the evening for the first four weeks and twice daily application in the morning and in the evening for the following 20 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene | Drug | Adapalene Gel 0.3% |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Scarring Severity | Grade Level:
| Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manisha J. Patel, MD | Johns Hopkins Medical Institut | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manisha PATEL | Baltimore | Maryland | 21231 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29549598 | Derived | Loss MJ, Leung S, Chien A, Kerrouche N, Fischer AH, Kang S. Adapalene 0.3% Gel Shows Efficacy for the Treatment of Atrophic Acne Scars. Dermatol Ther (Heidelb). 2018 Jun;8(2):245-257. doi: 10.1007/s13555-018-0231-8. Epub 2018 Mar 16. |
| Label | URL |
|---|---|
| Related Info | View source |
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First patient in =25 March 2011, last patient out= 21 Sep 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Differin® 0.3% Gel | Differin® 0.3% Gel Adapalene 0.3% Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population includes all 20 subjects enrolled into the study (Intent-to-Treat population).
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| ID | Title | Description |
|---|---|---|
| BG000 | Differin® 0.3% Gel | Differin® 0.3% Gel Adapalene 0.3% Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks. |
| 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 | Global Scarring Severity | Grade Level:
| The analysis population includes 18 subjects whose data were available at this time frame (week 24). | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
|
|
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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 | Differin® 0.3% Gel | Differin® 0.3% Gel Adapalene 0.3% Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fabien AUDIBERT, CPM | GALDERMA | + 33 4 92 95 29 21 | fabien.audibert@galderma.com |
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| ID | Term |
|---|---|
| D000068816 | Adapalene |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| 0 |
| 20 |
| 0 |
| 20 |
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| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |