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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azelaic acid 15% (Finacea) | Experimental | Open label pilot study, Topical gel to be appiled twice daily for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azelaic acid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to16 weeks |
| Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leon H. Kircik, M.D. | DermResearch, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DermResearch, PLLC | Louisville | Kentucky | 40217 | United States |
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Subjects recruited from private office population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Finacea | Open label pilot study. All subjects were given Azelaic acid 15% to be used topically, twice daily. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Finacea | Open label pilot study |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per protocol | Posted | Number | percentage of participants | Baseline to 16 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Finacea | Open label pilot study |
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This is an open-label study with a small number of subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leon Kircik, M.D. | DermResearch, PLLC | 502-451-9000 | wedoderm@yahoo.com |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C010038 | azelaic acid |
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The % distribution of PIH, evaluated on a scale of 0 = no PIH through 6 = greater than 50% |
| Baseline to 16 weeks |
| Percentage Change in Total Lesion Counts | Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones). | Baseline to 16 weeks |
| 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 | 16 weeks |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | per protocol | Posted | Number | percentage of participants | Baseline to16 weeks |
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| 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% | per protocol | Posted | Number | percentage of participants | Baseline to 16 weeks |
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| Secondary | Percentage Change in Total Lesion Counts | Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones). | per protocol | Posted | Mean | Standard Deviation | percentage of total lesion count | Baseline to 16 weeks |
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| 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 | per protocol | Posted | Number | participants | 16 weeks |
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| 0 |
| 20 |
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| 20 |
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| D010859 | Pigmentation Disorders |