| May 28, 2008 |
| February 16, 2009 |
| August 2008 |
| February 2009 (final data collection date for primary outcome measure) |
| Percent change from Baseline in total lesion count at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00688064 on ClinicalTrials.gov Archive Site |
- Percent change from Baseline in total lesion count at each intermediate visit, Percent change in inflammatory lesion count and in non-inflammatory lesion count at each post Baseline visit. [ Time Frame: Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
- Incidence of Adverse Events, Local tolerance worst-score post Baseline, Postinflammatory hyperpigmentation for subjects with phototypes IV to VI [ Time Frame: All along the study ] [ Designated as safety issue: Yes ]
- Investigator Global Assessment at each post Baseline visit, Global Improvement from Baseline at week 12/early termination [ Time Frame: Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris |
| Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With Doxycycline Hyclate 100 mg Tablets Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Vehicle Gel Associated With Doxycycline Hyclate 100 mg Tablets in the Treatment of Severe Acne Vulgaris. |
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated. |
Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR.29075) |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Severe Acne Vulgaris |
- Drug: Adapalene BPO Gel associated with Doxycyline Hyclate
- Drug: Vehicle Gel associated with Doxycycline Hyclate
|
- Experimental: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
- Active Comparator: Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
|
| |
| |
| Completed |
| 459 |
| February 2009 |
| February 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Male or female Subjects of any race, aged 12 to 35 years inclusive
- Subjects with severe facial acne (global severity score of 4)
- Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose
- Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose
Exclusion Criteria:
- Subjects with more than 3 nodules or cysts on the face,
- Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
|
| Both |
| 12 Years to 35 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada, Puerto Rico |
| |
| NCT00688064 |
| Jean-Charles DHUIN Clinical Trial Manager, Galderma |
| RD.03.SPR.29074 |
| Galderma |
|
| Principal Investigator: |
Linda Stein Gold, MD |
Henry Ford Medical Center-New Center One, Detroit, MI |
|
|
| Galderma |
| February 2009 |
