Acne Vulgaris
Conditions
Brief summary
Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Duac gel in combination to emulate real life practice.
Interventions
DRUGWinlevi (clascoterone) 1% & Duac gel
Participants will use Winlevi (clascoterone) 1% and Duac gel as per label
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i. Outpatient, male or female subjects of any race, and at least 12 years of age or older. * Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (test must have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study: * A female is considered of childbearing potential unless she is: 1. postmenopausal for at least 12 months prior to study drug administration; 2. without a uterus and/or both ovaries; or 3. Has been surgically sterile for at least 6 months prior to study drug administration. * Reliable methods of contraception are: 1. Hormonal methods or intrauterine device in use \> 90 days prior to study drug administration; 2. Barrier methods plus spermicide in use at least 14 days prior to study drug administration; or 3. Vasectomized partner (vasectomy must be performed 3 months prior to first study drug administration or in the alternative a zero sperm count will suffice). * Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study. ii. Facial acne IGA score of 3 or 4. iii. Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.
Exclusion criteria
i. Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control. ii. Allergy or sensitivity to any component of the test medications. iii. Subjects who have not complied with the proper wash-out periods for prohibited medications . iv. Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study. v. Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris vi. Evidence of recent alcohol or drug abuse. vii. History of poor cooperation, non-compliance with medical treatment, or unreliability. viii. Exposure to an investigational drug study within 30 days of the Baseline Visit. ix. Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. (4) • Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis (including pseudomembranous colitis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Endpoint of This Study is the Percent of Patients Who Achieve Clear or Almost Clear on Investigator Global Assessment (IGA) Scale at Week 16. | Week 16 | The investigator will evaluate global acne severity using the Investigator Global Assessment scale, which ranges from 0 to 5, where 0 represents clear skin and 5 represents very severe acne |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Inflammatory Lesion Reduction at Week 16 Compared to Baseline | Week 16 | — |
| Percent of Non-inflammatory Lesion Reduction at Week 16 Compared to Baseline. | Week 16 | — |
| Tolerability Measures of Erythema Based on 5-point Severity Scale | Week 4,8,12,16 | The score in the scale ranges from 0-4. Lower score represents absence of erythema and higher score represents severe condition. The information presented represents the Percentage of participant with Absent or Trace erythema at weeks 4,8,12 and 16 |
| Tolerability Measures of Dryness Based on 5-point Severity Scale | Week 4,8,12,16 | The score in the scale ranges from 0-4. Lower score represents absence of dryness and higher score represents severe condition. The information presented represents the Percentage of participant with Absent or Trace dryness at weeks 4,8,12 and 16. |
| Percent of Total Lesion Reduction at Week 16 Compared to Baseline | Week 16 | — |
| Assessment of Skin Oiliness Based on 5-point Severity Scale | Week 4,8,12,16 | The score in the scale ranges from 0-4. Score 0 represents absence of Oiliness and Score 4 represents severe condition. The information presented represents the Percentage of participant with Absent or Trace oiliness at weeks 4,8,12 and 16 |
| Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale | Week 4,8,12,16 | The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition. The information presented represents the Percentage of participant with Absent or Trace burning at weeks 4,8,12 and 16 |
| Tolerability Measures of Pruritus Based on 6-point Severity Scale | Week 4,8,12,16 | The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition. The information presented represents the Percentage of participant with Absent or Trace Pruritus at weeks 4,8,12 and 16 |
| Tolerability Measures of Peeling Based on 5-point Severity Scale | Week 4,8,12,16 | The score in the scale ranges from 0-4. Score 0 represents absence of peeling and Score 4 represents 'Extensive peeling'. The information presented represents the Percentage of participant with Absent or Trace peeling at weeks 4,8,12 and 16 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Winlevi (Clascoterone) 1% & Duac Gel Winlevi (clascoterone) 1% & Duac gel: Participants will use Winlevi (clascoterone) 1% and Duac gel as per label | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Winlevi (Clascoterone) 1% & Duac Gel |
|---|---|
| Age, Continuous | 33 years STANDARD_DEVIATION 17 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
The Primary Endpoint of This Study is the Percent of Patients Who Achieve Clear or Almost Clear on Investigator Global Assessment (IGA) Scale at Week 16.
The investigator will evaluate global acne severity using the Investigator Global Assessment scale, which ranges from 0 to 5, where 0 represents clear skin and 5 represents very severe acne
Time frame: Week 16
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Winlevi (Clascoterone) 1% & Duac Gel | The Primary Endpoint of This Study is the Percent of Patients Who Achieve Clear or Almost Clear on Investigator Global Assessment (IGA) Scale at Week 16. | 100 Percentage of patients |
Secondary
Assessment of Skin Oiliness Based on 5-point Severity Scale
The score in the scale ranges from 0-4. Score 0 represents absence of Oiliness and Score 4 represents severe condition. The information presented represents the Percentage of participant with Absent or Trace oiliness at weeks 4,8,12 and 16
Time frame: Week 4,8,12,16
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Winlevi (Clascoterone) 1% & Duac Gel | Assessment of Skin Oiliness Based on 5-point Severity Scale | Baseline | 100 percentage of participants |
| Winlevi (Clascoterone) 1% & Duac Gel | Assessment of Skin Oiliness Based on 5-point Severity Scale | Week 4 | 100 percentage of participants |
| Winlevi (Clascoterone) 1% & Duac Gel | Assessment of Skin Oiliness Based on 5-point Severity Scale | Week 8 | 100 percentage of participants |
| Winlevi (Clascoterone) 1% & Duac Gel | Assessment of Skin Oiliness Based on 5-point Severity Scale | Week 12 | 100 percentage of participants |
| Winlevi (Clascoterone) 1% & Duac Gel | Assessment of Skin Oiliness Based on 5-point Severity Scale | Week 16 | 100 percentage of participants |
p-value: 1Wilcoxon signed rank
Secondary
Percent of Inflammatory Lesion Reduction at Week 16 Compared to Baseline
Time frame: Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Winlevi (Clascoterone) 1% & Duac Gel | Percent of Inflammatory Lesion Reduction at Week 16 Compared to Baseline | 96.4 Percent change | Standard Deviation 6 |
p-value: 0.007Wilcoxon rank-sum test
Secondary
Percent of Non-inflammatory Lesion Reduction at Week 16 Compared to Baseline.
Time frame: Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Winlevi (Clascoterone) 1% & Duac Gel | Percent of Non-inflammatory Lesion Reduction at Week 16 Compared to Baseline. | 86.1 Percent change | Standard Deviation 15.3 |
p-value: 0.009Wilcoxon rank sum test
Secondary
Percent of Total Lesion Reduction at Week 16 Compared to Baseline
Time frame: Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Winlevi (Clascoterone) 1% & Duac Gel | Percent of Total Lesion Reduction at Week 16 Compared to Baseline | 92 Percent change | Standard Deviation 8.2 |
p-value: 0.008Wilcoxon (Mann-Whitney)
Secondary
Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale
The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition. The information presented represents the Percentage of participant with Absent or Trace burning at weeks 4,8,12 and 16
Time frame: Week 4,8,12,16
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale | Baseline | 100 percentage of participants |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale | Week 4 | 100 percentage of participants |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale | Week 8 | 88 percentage of participants |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale | Week 12 | 100 percentage of participants |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale | Week 16 | 100 percentage of participants |
Secondary
Tolerability Measures of Dryness Based on 5-point Severity Scale
The score in the scale ranges from 0-4. Lower score represents absence of dryness and higher score represents severe condition. The information presented represents the Percentage of participant with Absent or Trace dryness at weeks 4,8,12 and 16.
Time frame: Week 4,8,12,16
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Dryness Based on 5-point Severity Scale | Baseline | 100 Percentage of participant |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Dryness Based on 5-point Severity Scale | Week 4 | 100 Percentage of participant |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Dryness Based on 5-point Severity Scale | Week 8 | 100 Percentage of participant |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Dryness Based on 5-point Severity Scale | Week 12 | 100 Percentage of participant |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Dryness Based on 5-point Severity Scale | Week 16 | 100 Percentage of participant |
Secondary
Tolerability Measures of Erythema Based on 5-point Severity Scale
The score in the scale ranges from 0-4. Lower score represents absence of erythema and higher score represents severe condition. The information presented represents the Percentage of participant with Absent or Trace erythema at weeks 4,8,12 and 16
Time frame: Week 4,8,12,16
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Erythema Based on 5-point Severity Scale | Baseline | 66 Percentage of participant |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Erythema Based on 5-point Severity Scale | Week 4 | 88 Percentage of participant |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Erythema Based on 5-point Severity Scale | Week 8 | 88 Percentage of participant |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Erythema Based on 5-point Severity Scale | Week 12 | 88 Percentage of participant |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Erythema Based on 5-point Severity Scale | Week 16 | 100 Percentage of participant |
p-value: 0.037Wilcoxon signed rank
Secondary
Tolerability Measures of Peeling Based on 5-point Severity Scale
The score in the scale ranges from 0-4. Score 0 represents absence of peeling and Score 4 represents 'Extensive peeling'. The information presented represents the Percentage of participant with Absent or Trace peeling at weeks 4,8,12 and 16
Time frame: Week 4,8,12,16
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Peeling Based on 5-point Severity Scale | Baseline | 100 percentage of participants |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Peeling Based on 5-point Severity Scale | Week 4 | 100 percentage of participants |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Peeling Based on 5-point Severity Scale | Week 8 | 100 percentage of participants |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Peeling Based on 5-point Severity Scale | Week 12 | 100 percentage of participants |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Peeling Based on 5-point Severity Scale | Week 16 | 100 percentage of participants |
p-value: 1Wilcoxon signed rank
Secondary
Tolerability Measures of Pruritus Based on 6-point Severity Scale
The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition. The information presented represents the Percentage of participant with Absent or Trace Pruritus at weeks 4,8,12 and 16
Time frame: Week 4,8,12,16
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Pruritus Based on 6-point Severity Scale | Baseline | 100 percentage of partiicipants |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Pruritus Based on 6-point Severity Scale | Week 4 | 100 percentage of partiicipants |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Pruritus Based on 6-point Severity Scale | Week 8 | 100 percentage of partiicipants |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Pruritus Based on 6-point Severity Scale | Week 12 | 88 percentage of partiicipants |
| Winlevi (Clascoterone) 1% & Duac Gel | Tolerability Measures of Pruritus Based on 6-point Severity Scale | Week 16 | 100 percentage of partiicipants |