Acne Vulgaris, Post Inflammatory Hyperpigmentation
Conditions
Brief summary
Residual post-inflammatory hyperpigmentation (PIH)from acne is disturbing to individuals with skin of color. Finacea has been anecdotally known to be beneficial in resolving PIH related to acne vulgaris. However, it has not been clinically tested for this purpose. The current study will investigate the efficacy and safety of Finacea in the treatment of acne vulgaris and PIH.
Interventions
DRUGAzelaic acid
Apply sparingly to the face twice a day (morning and night). Massage gently into the skin until vanishing. Approximately 0.5g (2.5cm strip) is sufficient for the entire facial area.
Sponsors
Bayer
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
No
Inclusion criteria
* Male or female, at least 12 years of age * Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline * Fitzpatrick skin type IV to VI * Acne IGA (Investigator Global Assessment) score of 2 or 3 * Inflammatory lesions of 15-60 (with no more than 2 nodules) * Non-inflammatory lesions of 20-100 * Post Inflammatory Hyperpigmentation Investigator Global Assessment (PIH IGA) score of 3,4 or 5 * Able to understand the requirements of the study and sign Informed Consent/HIPAA forms. Subjects under the legal age of consent must have the written informed consent of a parent or legal guardian
Exclusion criteria
* Female subjects who are pregnant, breast-feeding or who are of childbearing potential and not practicing a reliable method of birth control * Allergy or sensitivity to any component of the test medication * Subjects who have not complied with the wash out periods for prohibited medications * Medical condition that contraindicates participation * Skin disease/disorder that might interfere with the diagnosis of acne vulgaris or PIH * Evidence of recent alcohol or drug abuse * History of poor cooperation, non-compliance or unreliability * Exposure to an investigational drug study within 30 day of Baseline visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment) | Baseline to 16 weeks | IGA Assessments at each visit (baseline and follow up) based on a 6 point scale (0= clear through 5 = very severe). Improvement is defined as at least a 1 point improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH) | Baseline to16 weeks | IGA for PIH assessed on a 7 point scale (0= clear through 6 = severe) with at least a two point improvement |
| Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution | Baseline to 16 weeks | The % distribution of PIH, evaluated on a scale of 0 = no PIH through 6 = greater than 50% |
| Percentage Change in Total Lesion Counts | Baseline to 16 weeks | Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones). |
| Tolerability Assessments as Measured by the Number of Participants With Side Effects | 16 weeks | Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus |
Countries
United States
Participant flow
Recruitment details
Subjects recruited from private office population.
Participants by arm
| Arm | Count |
|---|---|
| Finacea Open label pilot study | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Finacea |
|---|---|
| Age, Categorical <=18 years | 8 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age Continuous | 24 years STANDARD_DEVIATION 10.63 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)
IGA Assessments at each visit (baseline and follow up) based on a 6 point scale (0= clear through 5 = very severe). Improvement is defined as at least a 1 point improvement.
Time frame: Baseline to 16 weeks
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azelaic Acid 15% Open Label | Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment) | 92 percentage of participants |
Secondary
Percentage Change in Total Lesion Counts
Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones).
Time frame: Baseline to 16 weeks
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Azelaic Acid 15% Open Label | Percentage Change in Total Lesion Counts | -92.4 percentage of total lesion count | Standard Deviation 10.4 |
Secondary
Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution
The % distribution of PIH, evaluated on a scale of 0 = no PIH through 6 = greater than 50%
Time frame: Baseline to 16 weeks
Population: per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid 15% Open Label | Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution | 2 grade improvement | 92 percentage of participants |
| Azelaic Acid 15% Open Label | Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution | 1 grade improvement | 100 percentage of participants |
Secondary
Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)
IGA for PIH assessed on a 7 point scale (0= clear through 6 = severe) with at least a two point improvement
Time frame: Baseline to16 weeks
Population: per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azelaic Acid 15% Open Label | Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH) | 100 percentage of participants |
Secondary
Tolerability Assessments as Measured by the Number of Participants With Side Effects
Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus
Time frame: 16 weeks
Population: per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azelaic Acid 15% Open Label | Tolerability Assessments as Measured by the Number of Participants With Side Effects | 0 participants |