| May 28, 2008 |
| August 10, 2009 |
| November 2008 |
| July 2009 (final data collection date for primary outcome measure) |
| Maintenance rate for total lesions at Week 24 : defined as the percentage of subjects maintaining at least 50% of the improvement obtained with prior combination therapy, in terms of total lesion counts. [ Time Frame: Week 24 ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00687908 on ClinicalTrials.gov Archive Site |
- Maintenance rate for total lesions: at each intermediate visits, Maintenance rate for inflammatory lesions: at each post Baseline visit, Maintenance rate for non-inflammatory lesions: at each post Baseline visit [ Time Frame: Weeks 4, 8, 12, 16, 20 and 24 ] [ Designated as safety issue: No ]
- Incidence of Adverse Events, Local tolerance Worst-score post Baseline, Postinflammatory Hyperpigmentation Worst-score post Baseline. [ Time Frame: All along the study ] [ Designated as safety issue: Yes ]
|
- Maintenance rate for total lesions: at each intermediate visits, Maintenance rate for inflammatory lesions: at each post Baseline visit, Maintenance rate for non-inflammatory lesions: at each post Baseline visit [ Time Frame: Weeks 4, 8, 12, 16, 20 and 24 ] [ Designated as safety issue: No ]
- Incidence of Adverse Events, Local tolerance Worst-score post Baseline, Postiflammatory Hyperpigmentation Worst-score post Baseline. [ Time Frame: All along the study ] [ Designated as safety issue: Yes ]
|
| |
| Adapalene-BPO Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance |
| Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Vehicle Gel as a 6-month Acne Maintenance Treatment |
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed. |
This study is a follow-up to RD.03.SPR.29074 - ACCESS I - "Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris" |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Acne |
- Drug: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
- Drug: Vehicle Gel
|
- Experimental: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
- Placebo Comparator: Vehicle Gel
|
| |
| |
| Completed |
| 244 |
| July 2009 |
| July 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Subjects who completed the previous study (RD.03.SPR29074)and had obtained at least a good Improvement (Grade, 0, 1, 2 or 3)
Exclusion Criteria:
- Female Subjects who are pregnant, nursing or planning a pregnancy during the study
- Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc).
|
| Both |
| 12 Years to 35 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada, Puerto Rico |
| |
| NCT00687908 |
| Jean-Charles DHUIN Clinical Trial Manager, Galderma |
| RD.03.SPR.29075 |
| Galderma |
|
| Principal Investigator: |
Diane Thiboutot, MD |
Penn State College of Medicine, Hershey, PA |
|
|
| Galderma |
| August 2009 |
