Acne Vulgaris
Conditions
Brief summary
Randomized, multi-center, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne vulgaris.
Detailed description
Efficacy of Doryx Delayed Release Tablets to doxycycline hyclate will be assessed using an Investigator's Global Assessment (IGA) score and the absolute change from baseline to 12 weeks in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline to 12 weeks in non-inflammatory lesions count of Doryx Delayed Release Tablets compared to doxycycline hyclate will be evaluated.
Interventions
DRUGDoxycycline hyclate (Doryx)
150mg/day, oral, delayed release tablets
100 mg/day, oral, tablets, immediate release
Sponsors
Warner Chilcott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be 12 years of age or older. * Has a diagnosis of facial acne vulgaris with no more than two nodules on the face.
Exclusion criteria
* Is allergic to tetracycline-class antibiotics or to any ingredient in the study medication. * Has a history of pseudomembranous colitis or antibiotic-associated colitis. * Has a history of hepatitis or liver damage or renal impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Outcome According to Investigator's Global Assessment (IGA) | baseline and 12 weeks | The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks. |
| Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks | baseline and 12 weeks | Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks | baseline and 12 weeks | Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of non-inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Doxycycline Hyclate (Doryx) Delayed-release Tablets Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily | 48 |
| Doxycycline Hyclate Immediate-release Tablets Doxycycline hyclate immediate-release tablets, 100 mg once daily | 45 |
| Total | 93 |
Baseline characteristics
| Characteristic | Doxycycline Hyclate (Doryx) Delayed-release Tablets | Total | Doxycycline Hyclate Immediate-release Tablets |
|---|---|---|---|
| Age, Categorical <=18 years | 28 Participants | 49 Participants | 21 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 44 Participants | 24 Participants |
| Age Continuous | 19.3 years STANDARD_DEVIATION 5.8 | 20.1 years STANDARD_DEVIATION 6.9 | 20.9 years STANDARD_DEVIATION 7.9 |
| Ethnic Origin Hispanic | 27 participants | 53 participants | 26 participants |
| Ethnic Origin Not of Hispanic origin | 21 participants | 40 participants | 19 participants |
| Race Asian or Pacific Islander | 0 participants | 1 participants | 1 participants |
| Race Black | 3 participants | 8 participants | 5 participants |
| Race Caucasian | 22 participants | 40 participants | 18 participants |
| Race Other | 23 participants | 44 participants | 21 participants |
| Region of Enrollment United States | 48 participants | 93 participants | 45 participants |
| Sex: Female, Male Female | 17 Participants | 33 Participants | 16 Participants |
| Sex: Female, Male Male | 31 Participants | 60 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 48 | 11 / 45 |
| serious Total, serious adverse events | 1 / 48 | 1 / 45 |
Outcome results
Primary
Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks
Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.
Time frame: baseline and 12 weeks
Population: intention to treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Doxycycline Hyclate (Doryx) Delayed-release Tablets | Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks | 21.8 acne lesion count | Standard Deviation 13.8 |
| Doxycycline Hyclate Immediate-release Tablets | Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks | 26.6 acne lesion count | Standard Deviation 12.5 |
Comparison: Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.p-value: 0.033Cochran-Mantel-Haenszel
Primary
Successful Outcome According to Investigator's Global Assessment (IGA)
The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks.
Time frame: baseline and 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Doxycycline Hyclate (Doryx) Delayed-release Tablets | Successful Outcome According to Investigator's Global Assessment (IGA) | 18 participants |
| Doxycycline Hyclate Immediate-release Tablets | Successful Outcome According to Investigator's Global Assessment (IGA) | 19 participants |
Comparison: Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.p-value: 0.765Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks
Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of non-inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.
Time frame: baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Doxycycline Hyclate (Doryx) Delayed-release Tablets | Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks | 23.2 Acne lesion count | Standard Deviation 19.3 |
| Doxycycline Hyclate Immediate-release Tablets | Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks | 27.6 Acne lesion count | Standard Deviation 20 |
Comparison: Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.p-value: 0.29Cochran-Mantel-Haenszel