Demonstrate that a daily treatment regimen of adapalene 0.3%/benzoyl peroxide 2.5% gel + oral Doxycycline 200 mg is effective and safe in severe inflammatory acne with 3 or fewer nodules or cysts (non-nodulocystic) during a 12-week treatment period.
This Phase 4, 12-week, single-arm, open-label, multi-center investigational efficacy and safety study was conducted in subjects with severe inflammatory acne. Subjects who met the inclusion criteria and none of the exclusion criteria at the Screening visit returned to the clinic for baseline measures (Week 0) and to start treatment, which continued for up to 12 weeks. Treatment consisted of 2 investigational study drugs: * A/BPO 0.3%/2.5% gel applied to dry skin as directed by study staff once daily for 12 weeks, at night after washing. * Doxycycline hyclate 200 mg: each subject was to take 2 50-mg tablets of doxycycline hyclate in the morning and 2 at night, for a total of 4 tablets (a total of 200 mg) daily for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
186
Topical acne therapy
Tetracycline-class oral antibacterial 200 mg daily (2 tablets \[50 mg\], twice daily)
Galderma Laboratories, LP
Fort Worth, Texas, United States
Change in Number of Inflammatory Lesions
Change in Number of Inflammatory Lesions from baseline.
Time frame: Week 12
Number and Percent of Subjects With IGA Success
IGA Success is defined as an IGA rating of Clear (Grade 0) or Almost Clear (Grade 1)
Time frame: Weeks 4, 8, and 12
Percent Change From Baseline in Total Lesion Count
Percent Change From Baseline in Total Lesion Count.
Time frame: Weeks 4, 8, and 12
Change From Baseline in Total Lesion Count
Change From Baseline in Total Lesion Count.
Time frame: Weeks 4, 8, and 12
Percent Change From Baseline in Inflammatory Lesion Count
Percent Change From Baseline in Inflammatory Lesion Count.
Time frame: Weeks 4, 8, and 12
Change From Baseline in Inflammatory Lesion Count
Change From Baseline in Inflammatory Lesion Count.
Time frame: Weeks 4, 8, and 12
Percent Change From Baseline in Non-Inflammatory Lesion Count
Percent Change From Baseline in Non-Inflammatory Lesion Count.
Time frame: Weeks 4, 8, and 12
Change From Baseline in Non-Inflammatory Lesion Count
Change From Baseline in Non-Inflammatory Lesion Count.
Time frame: Weeks 4, 8, and 12
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Investigator's Evaluation: Number of Subjects Not Considered to be Oral Isotretinoin Candidates
At each visit, subjects were evaluated by the investigator to determine whether (in the opinion of the investigator) they would consider them as candidates for oral isotretinoin therapy. The outcome measure reports the number and % of subjects who, in the opinion of the investigator, were not considered to be "a candidate for oral isotretinoin therapy."
Time frame: Weeks 0, 4, 8, and 12
Subject Assessment of Acne Improvement
Subject Assessment of Acne Improvement on a 6 point scale (0 = Complete Improvement, 1 = Marked Improvement, 2 = Moderate Improvement, 3 = Minimal Improvement, 4 = No Change, 5 = Worse).
Time frame: Week 12
Number and Percent of Adverse Events
Number and percent of subjects with any Treatment-Related Adverse Event
Time frame: Week 12