| January 11, 2007 |
| October 19, 2009 |
| October 2006 |
| October 2007 (final data collection date for primary outcome measure) |
- Success Rate on the Investigator's Global Assessment [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
- Changes in Inflammatory Lesion Counts [ Time Frame: from Baseline to week 12 ] [ Designated as safety issue: No ]
- Changes in Noninflammatory Lesion Counts [ Time Frame: from Baseline to week 12 ] [ Designated as safety issue: No ]
|
- Success Rate on the Investigator’s Global Assessment
- Change in Inflammatory Lesion Counts
- Change in Noninflammatory Lesion Counts
|
| Complete list of historical versions of study NCT00421993 on ClinicalTrials.gov Archive Site |
- Percent Change in Inflammatory Lesion Counts [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
- Percent Change in Noniflammatory Lesion Counts [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
- Percent Change in Total Lesion Counts [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
|
- Percent Change in Lesion Counts (Inflammatory,Noninflammatory, Total)
- Change in Investigator’s Global Assessment (IGA)
- Subject’s Assessment of Acne
|
| |
| A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris |
| A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris |
This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study.
The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Acne Vulgaris |
- Drug: Adapalene/Benzoyl Peroxide
- Drug: Adapalene
- Drug: Benzoyl Peroxide
- Drug: Topical Gel Vehicle
|
- Experimental: Adapalene/Benzoyl Peroxide Topical Gel
- Active Comparator: Adapalene Topical Gel
- Active Comparator: Benzoyl Peroxide Topical Gel
- Placebo Comparator: Topical Gel Vehicle
|
| Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. Review. |
| |
| Completed |
| 1670 |
| December 2007 |
| October 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- A clinical diagnosis of acne vulgaris with facial involvement.
- A minimum of 20 but not more than 50 Inflammatory lesions
- A minimum of 30 but not more than 100 Noninflammatory lesions
- A score of 3 (Moderate) on the Investigator's Global Assessment Scale.
Exclusion Criteria:
- More than one acne nodule or any acne cyst.
- Acne conglobata, acne fulminans, secondary acne, or severe acne.
- Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.
- Underlying diseases that require the use of interfering topical or systemic therapy.
- Use of prohibited medications prior to the study unless appropriate washout period is documented
- Use of hormonal contraceptives solely for control of acne
|
| Both |
| 12 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada, Germany, Hungary, Poland |
| |
| NCT00421993 |
| Michael Graeber, MD, Head of US Development, Galderma |
| RD.06.SPR.18088 |
| Galderma |
|
| Study Director: |
Michael Graeber, MD |
Galderma |
|
|
| Galderma |
| October 2009 |