Acne Vulgaris
Conditions
Brief summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of ACZONE Gel, 7.5% administered topically once-daily for 12 weeks in 9 to 11 year-olds with acne vulgaris.
Interventions
DRUGdapsone gel
Dapsone (ACZONE) 7.5% gel topically once daily.
Sponsors
Allergan
Almirall, S.A.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
-Has acne vulgaris on the face, including the nose, with 20 to 100 total lesions (noninflammatory and/or inflammatory).
Exclusion criteria
* Has uncontrolled systemic disease(s) * Has severe cystic acne, acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne) * Has used topical dapsone within 1 month prior to the screening * Has used oral dapsone within 2 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Weight | Baseline (Day 1), Week 12 | Change from baseline in weight was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value. |
| Number of Participants With Adverse Events (AE) | From Baseline (Day 1) until Week 12 | An AE was defined as any untoward medical occurrence in a clinical trial participant (regardless of the administration of the study drug and its causal relationship to it). An AE could therefore, be any unfavorable and unintended medical occurrence during the participant's participation in the trial, including deterioration of a pre-existing medical condition, an abnormal clinically significant finding in a laboratory assessment, or an abnormal clinically significant finding in the physical examination or vital sign. |
| Change From Baseline in Systolic and Diastolic Blood Pressure | Baseline (Day 1), Week 12 | Change from baseline in systolic and diastolic blood pressure was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value. |
| Change From Baseline in Heart Rate | Baseline (Day 1), Week 12 | Change from baseline in heart rate was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value. |
| Change From Baseline in Respiratory Rate | Baseline (Day 1), Week 12 | Change from baseline in respiratory rate was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value. |
| Change From Baseline in Height | Baseline (Day 1), Week 12 | Change from baseline in height was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value. |
| Change From Baseline in Body Temperature | Baseline (Day 1), Week 12 | Change from baseline in body temperature was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value. |
| Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Week 12 | Local dermal tolerability was evaluated by investigator in terms of presence and absence of dryness, scaling and erythema symptoms and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point scale of 0 - 3, where 0 = none (no dryness, scaling and erythema) and 3 = severe (marked roughness, heavy scale production and intense redness). The higher score indicated severe symptoms. |
| Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants | Week 12 | Local dermal tolerability was evaluated by participants in terms of presence and absence of prickling pain sensation immediately after (within 5 minutes of dosing) and its severity in the areas of body where medication was applied (face). Stinging/burning symptoms were graded on a 4-point scale of 0 - 3 where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling/stinging sensation; not really bothersome), 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome), 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort). The higher score indicated severe symptoms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration of Dapsone,Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1 | Week 1 (Pre-dose and 10 hours post-dose) | The mean plasma peak (10 hours postdose) concentrations of dapsone, dapsone hydroxylamine and N-acetyl dapsone were reported. |
| Percentage of Participants With None (0) or Minimal (1) Score Plus at Least a 2-Grade Improvement on the Investigator's Global Assessment (IGA) for Face | Week 12 | Overall severity of acne vulgaris was evaluated by using a 5-point IGA scale: Clear (0) - (no comedones; papules or pustules, residual hyperpigmentation and erythema may be present); Almost clear (1) - (rare comedones; no more than a few small papules and pustules); Mild (2) - (easily recognizable comedones in limited numbers; +/- presence of small papules and pustules); Moderate (3) - (many comedones; +/- easily recognizable small and medium-sized papules; no nodules or cysts; Severe (4) - (widespread and numerous comedones; many small, medium-sized and large papules and pustules; nodules or cysts may or may not be present). |
| Trough Plasma Concentration of Dapsone, Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1 | Week 1 (Pre-dose) | The trough plasma concentrations of Dapsone, Dapsone hydroxylamine and N-acetyl dapsone were reported. |
| Absolute Change From Baseline in Inflammatory Lesion Counts | Baseline (Day 1), Week 12 | Inflammatory lesion counts were the sum of counts of the following lesion types (face only): Papule - a small, red, solid elevation less than (\<) 1.0 centimeter (cm) in diameter; Pustule - a small, circumscribed elevation of the skin that contains yellow-white exudate; Nodule - a circumscribed, elevated, solid lesion generally more than 1.0 cm in diameter with palpable depth; Cyst - a smooth, dome-shaped, elevated, freely moveable, skin-colored, round to ovoid lesion greater than 0.7 cm in diameter. Change from baseline was calculated by subtracting post-dose value from baseline value. |
| Percent Change From Baseline in Non-inflammatory Lesion Counts | Baseline (Day 1), Week 12 | Noninflammatory lesion counts were defined as the sum of counts of the following lesion type (face only): open comedone - a pigmented dilated pilosebaceous orifice (blackhead); closed comedone - a tiny white papule (whitehead). |
| Percent Change From Baseline in Inflammatory Lesion Counts | Baseline (Day 1), Week 12 | Inflammatory lesion counts were the sum of counts of the following lesion types (face only): Papule - a small, red, solid elevation less than 1.0 cm in diameter; Pustule - a small, circumscribed elevation of the skin that contains yellow-white exudate; Nodule - a circumscribed, elevated, solid lesion generally more than 1.0 cm in diameter with palpable depth; Cyst - a smooth, dome-shaped, elevated, freely moveable, skin colored, round to ovoid lesion greater than 0.7 cm in diameter. |
| Absolute Change From Baseline in Non-inflammatory Lesion Counts | Baseline (Day 1), Week 12 | Non-inflammatory lesion counts were defined as the sum of counts of the following lesion type (face only): open comedone - a pigmented dilated pilosebaceous orifice (blackhead); closed comedone - a tiny white papule (whitehead). Change from baseline was be calculated by subtracting post-dose value from the baseline value. |
| Absolute Change From Baseline in Total Lesion Counts on Face | Baseline (Day 1), Week 12 | Total lesion counts were defined as the sum of inflammatory lesion counts and noninflammatory lesion counts (face only). Change from baseline was be calculated by subtracting post-dose value from the baseline value. |
| Percent Change From Baseline in Total Lesion Counts on Face | Baseline (Day 1), Week 12 | Total lesion counts were defined as the sum of inflammatory lesion counts and noninflammatory lesion counts (face only). |
| Percentage of Participants With None (0) or Minimal (1) Score on the Investigator's Global Assessment (IGA) for Face | Week 12 | Overall severity of acne vulgaris was evaluated by using a 5-point IGA scale: Clear (0) - (no comedones; papules or pustules, residual hyperpigmentation and erythema may be present); Almost clear (1) - (rare comedones; no more than a few small papules and pustules); Mild (2) - (easily recognizable comedones in limited numbers; +/- presence of small papules and pustules); Moderate (3) - (many comedones; +/- easily recognizable small and medium-sized papules; no nodules or cysts; Severe (4) - (widespread and numerous comedones; many small, medium-sized and large papules and pustules; nodules or cysts may or may not be present). |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 20 sites in United States (US) between 31 October 2016 (first participant first visit) and 09 March 2018 (last participant last visit).
Pre-assignment details
A total of 105 participants were screened, out of which 100 participants were enrolled into either of the 2 cohorts, Pharmacokinetic (PK) Cohort and Non-PK Cohort.
Participants by arm
| Arm | Count |
|---|---|
| PK Cohort: ACZONE 7.5% Participants applied ACZONE 7.5 % gel topically, once-daily to the entire face, neck, upper chest, upper back and shoulders starting from Day 1 under maximal use conditions (2 grams per day) for Day 8 consecutive days, followed by a thin layer to their face and acne-affected areas on the upper chest, upper back, and shoulders for next 11 weeks. | 17 |
| Non-PK Cohort: ACZONE 7.5% Participants applied ACZONE 7.5% gel topically, once-daily in a thin layer to their face and acne-affected areas on upper chest, upper back, and shoulders for 12 weeks. | 83 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 5 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | PK Cohort: ACZONE 7.5% | Non-PK Cohort: ACZONE 7.5% | Total |
|---|---|---|---|
| Age, Continuous | 10.1 years STANDARD_DEVIATION 0.9 | 10.4 years STANDARD_DEVIATION 0.7 | 10.4 years STANDARD_DEVIATION 0.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 23 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 60 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 9 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 19 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 9 Participants | 53 Participants | 62 Participants |
| Sex: Female, Male Female | 15 Participants | 59 Participants | 74 Participants |
| Sex: Female, Male Male | 2 Participants | 24 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 83 |
| other Total, other adverse events | 5 / 17 | 16 / 83 |
| serious Total, serious adverse events | 0 / 17 | 0 / 83 |
Outcome results
Primary
Change From Baseline in Body Temperature
Change from baseline in body temperature was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Time frame: Baseline (Day 1), Week 12
Population: Safety population included all participants who received at least one application of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PK Cohort: ACZONE 7.5% | Change From Baseline in Body Temperature | 0.08 degree celsius (°C) | Standard Deviation 0.26 |
| Non-PK Cohort: ACZONE 7.5% | Change From Baseline in Body Temperature | 0.10 degree celsius (°C) | Standard Deviation 0.38 |
Primary
Change From Baseline in Heart Rate
Change from baseline in heart rate was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.
Time frame: Baseline (Day 1), Week 12
Population: Safety population included all participants who received at least one application of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PK Cohort: ACZONE 7.5% | Change From Baseline in Heart Rate | -0.8 beats per minute (beats/min) | Standard Deviation 14 |
| Non-PK Cohort: ACZONE 7.5% | Change From Baseline in Heart Rate | 0.6 beats per minute (beats/min) | Standard Deviation 9.5 |
Primary
Change From Baseline in Height
Change from baseline in height was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Time frame: Baseline (Day 1), Week 12
Population: Safety population included all participants who received at least one application of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PK Cohort: ACZONE 7.5% | Change From Baseline in Height | 0.21 centimeter (cm) | Standard Deviation 0.76 |
| Non-PK Cohort: ACZONE 7.5% | Change From Baseline in Height | 1.01 centimeter (cm) | Standard Deviation 1.77 |
Primary
Change From Baseline in Respiratory Rate
Change from baseline in respiratory rate was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Time frame: Baseline (Day 1), Week 12
Population: Safety population included all participants who received at least one application of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PK Cohort: ACZONE 7.5% | Change From Baseline in Respiratory Rate | 0.5 breaths per minute (breaths/min) | Standard Deviation 2.4 |
| Non-PK Cohort: ACZONE 7.5% | Change From Baseline in Respiratory Rate | -0.1 breaths per minute (breaths/min) | Standard Deviation 1.6 |
Primary
Change From Baseline in Systolic and Diastolic Blood Pressure
Change from baseline in systolic and diastolic blood pressure was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.
Time frame: Baseline (Day 1), Week 12
Population: Safety population included all participants who received at least one application of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PK Cohort: ACZONE 7.5% | Change From Baseline in Systolic and Diastolic Blood Pressure | Systolic Blood Pressure | 3.9 millimeter of mercury (mmHg) | Standard Deviation 8.2 |
| PK Cohort: ACZONE 7.5% | Change From Baseline in Systolic and Diastolic Blood Pressure | Diastolic Blood Pressure | 2.3 millimeter of mercury (mmHg) | Standard Deviation 5.9 |
| Non-PK Cohort: ACZONE 7.5% | Change From Baseline in Systolic and Diastolic Blood Pressure | Systolic Blood Pressure | 0.1 millimeter of mercury (mmHg) | Standard Deviation 10.1 |
| Non-PK Cohort: ACZONE 7.5% | Change From Baseline in Systolic and Diastolic Blood Pressure | Diastolic Blood Pressure | 0.4 millimeter of mercury (mmHg) | Standard Deviation 9.1 |
Primary
Change From Baseline in Weight
Change from baseline in weight was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Time frame: Baseline (Day 1), Week 12
Population: Safety population included all participants who received at least one application of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PK Cohort: ACZONE 7.5% | Change From Baseline in Weight | 0.70 kilogram (kg) | Standard Deviation 1.98 |
| Non-PK Cohort: ACZONE 7.5% | Change From Baseline in Weight | 1.48 kilogram (kg) | Standard Deviation 1.72 |
Primary
Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator
Local dermal tolerability was evaluated by investigator in terms of presence and absence of dryness, scaling and erythema symptoms and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point scale of 0 - 3, where 0 = none (no dryness, scaling and erythema) and 3 = severe (marked roughness, heavy scale production and intense redness). The higher score indicated severe symptoms.
Time frame: Week 12
Population: Safety population included all participants who received at least one application of study drug. Here, number analyzed signifies number of participants with available data for the specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Dryness: None (0) | 15 participants |
| PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Dryness: Mild (1) | 0 participants |
| PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Dryness: Moderate (2) | 0 participants |
| PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Dryness: Severe (3) | 0 participants |
| PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Scaling: None (0) | 15 participants |
| PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Scaling: Mild (1) | 0 participants |
| PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Scaling: Moderate (2) | 0 participants |
| PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Scaling: Severe (3) | 0 participants |
| PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Erythema: None (0) | 13 participants |
| PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Erythema: Mild (1) | 2 participants |
| PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Erythema: Moderate (2) | 0 participants |
| PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Erythema: Severe (3) | 0 participants |
| Non-PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Erythema: Moderate (2) | 0 participants |
| Non-PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Dryness: None (0) | 71 participants |
| Non-PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Scaling: Moderate (2) | 1 participants |
| Non-PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Dryness: Mild (1) | 6 participants |
| Non-PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Erythema: Mild (1) | 12 participants |
| Non-PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Dryness: Moderate (2) | 0 participants |
| Non-PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Scaling: Severe (3) | 0 participants |
| Non-PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Dryness: Severe (3) | 0 participants |
| Non-PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Erythema: Severe (3) | 0 participants |
| Non-PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Scaling: None (0) | 70 participants |
| Non-PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Erythema: None (0) | 65 participants |
| Non-PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | Scaling: Mild (1) | 6 participants |
Primary
Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants
Local dermal tolerability was evaluated by participants in terms of presence and absence of prickling pain sensation immediately after (within 5 minutes of dosing) and its severity in the areas of body where medication was applied (face). Stinging/burning symptoms were graded on a 4-point scale of 0 - 3 where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling/stinging sensation; not really bothersome), 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome), 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort). The higher score indicated severe symptoms.
Time frame: Week 12
Population: Safety population included all participants who received at least one application of study drug. Here, number analyzed signifies number of participants with available data for the specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants | None (0) | 15 participants |
| PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants | Mild (1) | 0 participants |
| PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants | Moderate (2) | 0 participants |
| PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants | Severe (3) | 0 participants |
| Non-PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants | Severe (3) | 0 participants |
| Non-PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants | None (0) | 75 participants |
| Non-PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants | Moderate (2) | 0 participants |
| Non-PK Cohort: ACZONE 7.5% | Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants | Mild (1) | 2 participants |
Primary
Number of Participants With Adverse Events (AE)
An AE was defined as any untoward medical occurrence in a clinical trial participant (regardless of the administration of the study drug and its causal relationship to it). An AE could therefore, be any unfavorable and unintended medical occurrence during the participant's participation in the trial, including deterioration of a pre-existing medical condition, an abnormal clinically significant finding in a laboratory assessment, or an abnormal clinically significant finding in the physical examination or vital sign.
Time frame: From Baseline (Day 1) until Week 12
Population: Safety population included all participants who received at least one application of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PK Cohort: ACZONE 7.5% | Number of Participants With Adverse Events (AE) | 5 Participants |
| Non-PK Cohort: ACZONE 7.5% | Number of Participants With Adverse Events (AE) | 16 Participants |
Other Pre-specified
Absolute Change From Baseline in Inflammatory Lesion Counts
Inflammatory lesion counts were the sum of counts of the following lesion types (face only): Papule - a small, red, solid elevation less than (\<) 1.0 centimeter (cm) in diameter; Pustule - a small, circumscribed elevation of the skin that contains yellow-white exudate; Nodule - a circumscribed, elevated, solid lesion generally more than 1.0 cm in diameter with palpable depth; Cyst - a smooth, dome-shaped, elevated, freely moveable, skin-colored, round to ovoid lesion greater than 0.7 cm in diameter. Change from baseline was calculated by subtracting post-dose value from baseline value.
Time frame: Baseline (Day 1), Week 12
Population: Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment. This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PK Cohort: ACZONE 7.5% | Absolute Change From Baseline in Inflammatory Lesion Counts | -6.2 lesions | Standard Deviation 9.3 |
Other Pre-specified
Absolute Change From Baseline in Non-inflammatory Lesion Counts
Non-inflammatory lesion counts were defined as the sum of counts of the following lesion type (face only): open comedone - a pigmented dilated pilosebaceous orifice (blackhead); closed comedone - a tiny white papule (whitehead). Change from baseline was be calculated by subtracting post-dose value from the baseline value.
Time frame: Baseline (Day 1), Week 12
Population: Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment. This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PK Cohort: ACZONE 7.5% | Absolute Change From Baseline in Non-inflammatory Lesion Counts | -17.8 lesions | Standard Deviation 17 |
Other Pre-specified
Absolute Change From Baseline in Total Lesion Counts on Face
Total lesion counts were defined as the sum of inflammatory lesion counts and noninflammatory lesion counts (face only). Change from baseline was be calculated by subtracting post-dose value from the baseline value.
Time frame: Baseline (Day 1), Week 12
Population: Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment.This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PK Cohort: ACZONE 7.5% | Absolute Change From Baseline in Total Lesion Counts on Face | -24.0 lesions | Standard Deviation 23 |
Other Pre-specified
Peak Plasma Concentration of Dapsone,Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1
The mean plasma peak (10 hours postdose) concentrations of dapsone, dapsone hydroxylamine and N-acetyl dapsone were reported.
Time frame: Week 1 (Pre-dose and 10 hours post-dose)
Population: Pharmacokinetic (PK) population included all participants who received applications of study drug for at least 8 days under maximal use conditions and had evaluable blood samples for PK analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PK Cohort: ACZONE 7.5% | Peak Plasma Concentration of Dapsone,Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1 | Dapsone | 20.0 nanogram per milliter (ng/mL) | Standard Deviation 12.5 |
| PK Cohort: ACZONE 7.5% | Peak Plasma Concentration of Dapsone,Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1 | Dapsone hydroxylamine | 1.40 nanogram per milliter (ng/mL) | Standard Deviation 1.1 |
| PK Cohort: ACZONE 7.5% | Peak Plasma Concentration of Dapsone,Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1 | N-acetyl dapsone | 9.01 nanogram per milliter (ng/mL) | Standard Deviation 7.37 |
Other Pre-specified
Percentage of Participants With None (0) or Minimal (1) Score on the Investigator's Global Assessment (IGA) for Face
Overall severity of acne vulgaris was evaluated by using a 5-point IGA scale: Clear (0) - (no comedones; papules or pustules, residual hyperpigmentation and erythema may be present); Almost clear (1) - (rare comedones; no more than a few small papules and pustules); Mild (2) - (easily recognizable comedones in limited numbers; +/- presence of small papules and pustules); Moderate (3) - (many comedones; +/- easily recognizable small and medium-sized papules; no nodules or cysts; Severe (4) - (widespread and numerous comedones; many small, medium-sized and large papules and pustules; nodules or cysts may or may not be present).
Time frame: Week 12
Population: Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment. This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PK Cohort: ACZONE 7.5% | Percentage of Participants With None (0) or Minimal (1) Score on the Investigator's Global Assessment (IGA) for Face | 46.7 percentage of participants |
Other Pre-specified
Percentage of Participants With None (0) or Minimal (1) Score Plus at Least a 2-Grade Improvement on the Investigator's Global Assessment (IGA) for Face
Overall severity of acne vulgaris was evaluated by using a 5-point IGA scale: Clear (0) - (no comedones; papules or pustules, residual hyperpigmentation and erythema may be present); Almost clear (1) - (rare comedones; no more than a few small papules and pustules); Mild (2) - (easily recognizable comedones in limited numbers; +/- presence of small papules and pustules); Moderate (3) - (many comedones; +/- easily recognizable small and medium-sized papules; no nodules or cysts; Severe (4) - (widespread and numerous comedones; many small, medium-sized and large papules and pustules; nodules or cysts may or may not be present).
Time frame: Week 12
Population: Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment.This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PK Cohort: ACZONE 7.5% | Percentage of Participants With None (0) or Minimal (1) Score Plus at Least a 2-Grade Improvement on the Investigator's Global Assessment (IGA) for Face | 19.6 percentage of participants |
Other Pre-specified
Percent Change From Baseline in Inflammatory Lesion Counts
Inflammatory lesion counts were the sum of counts of the following lesion types (face only): Papule - a small, red, solid elevation less than 1.0 cm in diameter; Pustule - a small, circumscribed elevation of the skin that contains yellow-white exudate; Nodule - a circumscribed, elevated, solid lesion generally more than 1.0 cm in diameter with palpable depth; Cyst - a smooth, dome-shaped, elevated, freely moveable, skin colored, round to ovoid lesion greater than 0.7 cm in diameter.
Time frame: Baseline (Day 1), Week 12
Population: Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment.This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PK Cohort: ACZONE 7.5% | Percent Change From Baseline in Inflammatory Lesion Counts | -56.38 percent change | Standard Deviation 43.43 |
Other Pre-specified
Percent Change From Baseline in Non-inflammatory Lesion Counts
Noninflammatory lesion counts were defined as the sum of counts of the following lesion type (face only): open comedone - a pigmented dilated pilosebaceous orifice (blackhead); closed comedone - a tiny white papule (whitehead).
Time frame: Baseline (Day 1), Week 12
Population: Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment. This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PK Cohort: ACZONE 7.5% | Percent Change From Baseline in Non-inflammatory Lesion Counts | -46.45 percent change | Standard Deviation 69.9 |
Other Pre-specified
Percent Change From Baseline in Total Lesion Counts on Face
Total lesion counts were defined as the sum of inflammatory lesion counts and noninflammatory lesion counts (face only).
Time frame: Baseline (Day 1), Week 12
Population: Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment. This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PK Cohort: ACZONE 7.5% | Percent Change From Baseline in Total Lesion Counts on Face | -51.91 percent change | Standard Deviation 33.53 |
Other Pre-specified
Trough Plasma Concentration of Dapsone, Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1
The trough plasma concentrations of Dapsone, Dapsone hydroxylamine and N-acetyl dapsone were reported.
Time frame: Week 1 (Pre-dose)
Population: Pharmacokinetic (PK) population included all participants who received applications of study drug for at least 8 days under maximal use conditions and had evaluable blood samples for PK analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PK Cohort: ACZONE 7.5% | Trough Plasma Concentration of Dapsone, Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1 | N-acetyl dapsone | 7.02 ng/mL | Standard Deviation 5.28 |
| PK Cohort: ACZONE 7.5% | Trough Plasma Concentration of Dapsone, Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1 | Dapsone | 17.2 ng/mL | Standard Deviation 14 |
| PK Cohort: ACZONE 7.5% | Trough Plasma Concentration of Dapsone, Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1 | Dapsone hydroxylamine | 1.05 ng/mL | Standard Deviation 0.979 |