Acne
Conditions
Brief summary
To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the trunk
Detailed description
This is an open label pilot study to determine the safety and efficacy of Dapsone (Aczone) 7.5% gel applied daily to the trunk for acne. Subjects will apply Dapsone for 16 weeks.
Interventions
Dapsone gel 7.5% applied once daily to truncal acne
Sponsors
Derm Research, PLLC
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
Yes
Inclusion criteria
* Male and female subjects of any race and at least 12 years of age. * Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception throughout the study. * Truncal acne IGA score of 3. * Able to understand the requirements of study and sign Informed Consent/HIPAA forms.
Exclusion criteria
* Female subjects who are pregnant , breast feeding or are of childbearing potential who are not willing to use a reliable method birth control. * Subjects who have an allergy or sensitivity to any component of the test medication. * Subjects who have not complied with the proper wash out periods for prohibited medications. * Evidence of recent drug or alcohol abuse. * Skin disease /disorder that might interfere with the diagnosis or evaluation of truncal acne. * Exposure to an investigational drug within 30 days of the Baseline visit. * Medical condition that contraindicates the subject's participation in the study. * History of poor cooperation, non-compliance with medical treatment or unreliability.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale | 16 weeks | Investigator will evaluate global acne severity using the IGA scale as follows: 1= Clear Skin, 2 = Almost Clear, 3 = Mild Severity, 4 = Severe, 5 = Very Severe |
Secondary
| Measure | Time frame |
|---|---|
| The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline | 16 Weeks |
| The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline | 16 Weeks |
| The Percent Change in Total Lesion Count at Week 16 Compared to Baseline | 16 Weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dapsone Gel 7.5% Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.
Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Dapsone Gel 7.5% |
|---|---|
| Age, Continuous | 21 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 3 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale
Investigator will evaluate global acne severity using the IGA scale as follows: 1= Clear Skin, 2 = Almost Clear, 3 = Mild Severity, 4 = Severe, 5 = Very Severe
Time frame: 16 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dapsone Gel 7.5% | Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale | week 10 | 3 Participants |
| Dapsone Gel 7.5% | Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale | week 16 | 7 Participants |
| Dapsone Gel 7.5% | Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale | week 4 | 0 Participants |
Secondary
The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline
Time frame: 16 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapsone Gel 7.5% | The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline | -74 percent change in lesion count | Standard Deviation 21 |
Secondary
The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline
Time frame: 16 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapsone Gel 7.5% | The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline | -72 percent change in lesion count | Standard Deviation 28 |
Secondary
The Percent Change in Total Lesion Count at Week 16 Compared to Baseline
Time frame: 16 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapsone Gel 7.5% | The Percent Change in Total Lesion Count at Week 16 Compared to Baseline | -73 percent change in lesion count | Standard Deviation 23 |