A Phase 4 interventional study of Azelaic acid in Acne Vulgaris and Post Inflammatory Hyperpigmentation, sponsored by Derm Research, PLLC. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2012-09-25.
Sponsored by Derm Research, PLLC · Phase 4, Interventional, and Treatment
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.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 20 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Derm Research, PLLC is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Open label pilot study, Topical gel to be appiled twice daily for 16 weeks
Drug: Azelaic 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.
Also known as: Finacea
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
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
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
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
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
Subjects recruited from private office population.
| Milestone | Finacea |
|---|---|
| Started | 20 |
| Completed | 13 |
| Not completed | 7 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lost to follow-up | 6 |
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.
| percentage of participants | Azelaic Acid 15% Open Label |
|---|---|
| Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment) | 92 |
IGA for PIH assessed on a 7 point scale (0= clear through 6 = severe) with at least a two point improvement
| percentage of participants | Azelaic Acis 15% Open Label |
|---|---|
| Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH) | 100 |
The % distribution of PIH, evaluated on a scale of 0 = no PIH through 6 = greater than 50%
| percentage of participants | Azelaic Acid 15% |
|---|---|
| 2 grade improvement | 92 |
| 1 grade improvement | 100 |
Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones).
| percentage of total lesion count | Azelaic Acid 15% |
|---|---|
| Percentage Change in Total Lesion Counts | -92.4 ± 10.4 |
Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus
| participants | Azelaic Acid 15% |
|---|---|
| Tolerability Assessments as Measured by the Number of Participants With Side Effects | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Finacea | — | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Finacea |
|---|---|
| <=18 years | 8 |
| Between 18 and 65 years | 12 |
| >=65 years | 0 |
| Age Continuous(years) | Finacea |
|---|---|
| Mean | 24 ± 10.63 |
| Sex: Female, Male(Participants) | Finacea |
|---|---|
| Female | 15 |
| Male | 5 |
| Region of Enrollment(participants) | Finacea |
|---|---|
| United States | 20 |
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Derm Research, PLLC