Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00599521 |
Recruitment Status :
Completed
First Posted : January 23, 2008
Results First Posted : April 19, 2011
Last Update Posted : February 18, 2021
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Sponsor:
Galderma R&D
Information provided by:
Galderma R&D
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Acne Vulgaris |
Interventions |
Drug: Adapalene lotion 0.1% Drug: Adapalene Lotion Vehicle |
Enrollment | 1067 |
Participant Flow
Recruitment Details | Multi center study recruitment period: First subject enrolled Nov 6, 2007; last subject completed Nov 14, 2008 |
Pre-assignment Details | 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. |
Arm/Group Title | Adapalene Lotion 0.1% | Adapalene Lotion Vehicle 0% |
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once a day for 12 weeks | once a day for 12 weeks |
Period Title: Overall Study | ||
Started | 535 | 531 |
Completed | 475 | 462 |
Not Completed | 60 | 69 |
Reason Not Completed | ||
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
Arm/Group Title | Adapalene Lotion 0.1% | Adapalene Lotion Vehicle 0% | Total | |
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once a day for 12 weeks | once a day for 12 weeks | Total of all reporting groups | |
Overall Number of Baseline Participants | 535 | 531 | 1066 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 535 participants | 531 participants | 1066 participants | |
<=18 years |
338 63.2%
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336 63.3%
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674 63.2%
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Between 18 and 65 years |
197 36.8%
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195 36.7%
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392 36.8%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 535 participants | 531 participants | 1066 participants | |
19.1 (6.8) | 19.2 (7.3) | 19.15 (7.05) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 535 participants | 531 participants | 1066 participants | |
Female |
300 56.1%
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272 51.2%
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572 53.7%
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Male |
235 43.9%
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259 48.8%
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494 46.3%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 535 participants | 531 participants | 1066 participants |
United States | 487 | 484 | 971 | |
Canada | 48 | 47 | 95 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
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.
disclosure restriction varies per institutional request/agreement
Results Point of Contact
Name/Title: | Michael Graeber MD/ Head of Global Clinical Project Management |
Organization: | Galderma |
Phone: | 609-860-8201 |
EMail: | michael.graeber@galderma.com |
Responsible Party: | Marie Ciardella Clinical Trials.gov Administrator, Galderma Laboratories, Inc |
ClinicalTrials.gov Identifier: | NCT00599521 |
Other Study ID Numbers: |
RD.06.SPR.18114 IND 076057 |
First Submitted: | January 11, 2008 |
First Posted: | January 23, 2008 |
Results First Submitted: | April 16, 2010 |
Results First Posted: | April 19, 2011 |
Last Update Posted: | February 18, 2021 |