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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition: |
Acne Vulgaris |
| Interventions: |
Drug: Adapalene lotion 0.1% Drug: Adapalene Lotion Vehicle |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Multi center study recruitment period: First subject enrolled Nov 6, 2007; last subject completed Nov 14, 2008 |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Washout requirements: 2 weeks for systemic anti-inflammatory drugs, 4 weeks for oral antibiotics, 2 months for inhaled/nasal steroids and 6 months for hormonal contraceptives/therapies. |
| Description | |
|---|---|
| Adapalene Lotion 0.1% | once a day for 12 weeks |
| Adapalene Lotion Vehicle 0% | once a day for 12 weeks |
| Adapalene Lotion 0.1% | Adapalene Lotion Vehicle 0% | |
|---|---|---|
| STARTED | 535 | 531 |
| COMPLETED | 475 | 462 |
| NOT COMPLETED | 60 | 69 |
| Lack of Efficacy | 4 | 8 |
| Adverse Event | 4 | 1 |
| Withdrawal by Subject | 28 | 34 |
| Protocol Violation | 1 | 1 |
| Lost to Follow-up | 23 | 23 |
| Pregnancy | 0 | 2 |
Baseline Characteristics
| Description | |
|---|---|
| Adapalene Lotion 0.1% | once a day for 12 weeks |
| Adapalene Lotion Vehicle 0% | once a day for 12 weeks |
| Adapalene Lotion 0.1% | Adapalene Lotion Vehicle 0% | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
535 | 531 | 1066 |
|
Age
[units: participants] |
|||
| <=18 years | 338 | 336 | 674 |
| Between 18 and 65 years | 197 | 195 | 392 |
| >=65 years | 0 | 0 | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
19.1 ± 6.8 | 19.2 ± 7.3 | 19.15 ± 7.05 |
|
Gender
[units: participants] |
|||
| Female | 300 | 272 | 572 |
| Male | 235 | 259 | 494 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 487 | 484 | 971 |
| Canada | 48 | 47 | 95 |
Outcome Measures
| 1. Primary: | Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12 [ Time Frame: From Baseline to Week 12 ] |
| 2. Primary: | Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12 [ Time Frame: Baseline to 12 weeks ] |
| 3. Primary: | Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ] |
| 4. Primary: | Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ] |
| 5. Secondary: | Mean Percent Change in Total Lesion Count From Baseline to Week 12 [ Time Frame: From Baseline to 12 weeks ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | Marie Ciardella Clinical Trials.gov Administrator, Galderma Laboratories, Inc |
| ClinicalTrials.gov Identifier: | NCT00599521 History of Changes |
| Other Study ID Numbers: | RD.06.SPR.18114, IND 076057 |
| Study First Received: | January 11, 2008 |
| Results First Received: | April 16, 2010 |
| Last Updated: | March 21, 2011 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |