Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris (ACCESS I)
This study has been completed.
Sponsor:
Galderma
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00688064
First received: May 28, 2008
Last updated: March 31, 2010
Last verified: March 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Severe Acne Vulgaris |
Drug: Adapalene BPO Gel associated with Doxycyline Hyclate Drug: Vehicle Gel associated with Doxycycline Hyclate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
MedlinePlus related topics:
Acne
Drug Information available for:
Benzoyl peroxide
Doxycycline
Doxycycline monohydrate
Doxycycline Hyclate
Doxycycline calcium
Adapalene
U.S. FDA Resources
Further study details as provided by Galderma:
Primary Outcome Measures:
- Percent Change From Baseline in Total Lesion Counts at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percent Change From Baseline in Inflammatory Lesion Counts at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Success Rate on the Investigator's Global Assessment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]Percentage of subjects graded "Clear" or "Almost Clear" on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe)at week 12
- Percent of Subjects With Adverse Events [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period)
| Enrollment: | 459 |
| Study Start Date: | August 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Adapalene-BPO + Doxycyline
|
Drug: Adapalene BPO Gel associated with Doxycyline Hyclate
Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
Other Name: Adapalene-BPO gel + Doxycycline
|
|
Active Comparator: 2
Vehicle + Doxycycline
|
Drug: Vehicle Gel associated with Doxycycline Hyclate
Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
Other Name: Vehicle gel + Doxycycline
|
Detailed Description:
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)
Eligibility| Ages Eligible for Study: | 12 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688064
Show 34 Study Locations
Show 34 Study LocationsSponsors and Collaborators
Galderma
Investigators
| Principal Investigator: | Linda Stein Gold, MD | Henry Ford Medical Center-New Center One, Detroit, MI |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jean-Charles DHUIN Clinical Trial Manager, Galderma |
| ClinicalTrials.gov Identifier: | NCT00688064 History of Changes |
| Other Study ID Numbers: | RD.03.SPR.29074 |
| Study First Received: | May 28, 2008 |
| Results First Received: | February 23, 2010 |
| Last Updated: | March 31, 2010 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board Canada: Health Canada Canada: Ethics Review Committee |
Keywords provided by Galderma:
|
Acne |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases Adapalene Benzoyl Peroxide Doxycycline Doxycycline hyclate Dermatologic Agents Therapeutic Uses Pharmacologic Actions Anti-Bacterial Agents |
Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013