Acne VulgarisPhase 4NCT01038869

Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation (PIH)

A Phase 4 study testing Azelaic acid in people with Acne Vulgaris and Post Inflammatory Hyperpigmentation, run by Derm Research, PLLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Acne Vulgaris, Post Inflammatory Hyperpigmentation
What is being tested?: Azelaic acid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Dec 2009to May 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

DermResearch, PLLC
Louisville, Kentucky, 40217

Other trials in United States

About this study

Official title: Efficacy and Safety of Finacea in the Treatment of Post-Inflammatory Hyperpigmentation and Acne Vulgaris

Conditions: Acne Vulgaris, Post Inflammatory Hyperpigmentation
Being tested: Azelaic acid
Medical subject headings: Acne Vulgaris, Hyperpigmentation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Azelaic acidDrug
Also called Finacea
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.

Study groups in NCT01038869
Study group	Role	What they receive
Azelaic acid 15% (Finacea)	Experimental	Open label pilot study, Topical gel to be appiled twice daily for 16 weeks Receives: Drug: Azelaic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 16 weeks

Secondary outcomes (4)

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
Measured: 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%
Measured: 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).
Measured: 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
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009May 2010

First posted24 Dec 2009 (estimated)
Study startDec 2009
Primary completionApr 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01038869
Sponsor's protocol ID: FIN0901
Status last verified: Aug 2012
First submitted: 23 Dec 2009
Last updated: 25 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
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RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Finacea in the Treatment of Post-Inflammatory Hyperpigmentation and Acne Vulgaris
ClinicalTrials.gov ID: NCT01038869
Acronym / sponsor ID: FIN0901
Conditions: Acne Vulgaris, Post Inflammatory Hyperpigmentation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Derm Research, PLLCUniversity, hospital or other
Collaborators: Bayer
Study start: Dec 2009
Primary completion: Apr 2010 (actual)
Study completion: May 2010 (actual)
First posted: 24 Dec 2009 (estimated)
Results: Posted 25 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Azelaic acid 15% (Finacea)	Experimental	Drug: Azelaic acidOpen label pilot study, Topical gel to be appiled twice daily for 16 weeks

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

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)

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Azelaic acidAlso: FinaceaApply 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.	Drug	Azelaic acid 15% (Finacea)

Primary outcome

Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)
Time frame: 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.

4 secondary outcomes

Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)
Time frame: Baseline to16 weeks
Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution
Time frame: Baseline to 16 weeks
Percentage Change in Total Lesion Counts
Time frame: Baseline to 16 weeks
Tolerability Assessments as Measured by the Number of Participants With Side Effects
Time frame: 16 weeks

Results and safety

Results posted to the registry on 25 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Finacea	20	13

Primary outcome: Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)

Time frame: Baseline to 16 weeks. Number. Unit: percentage of participants

Measure	Azelaic Acid 15% Open Label n = 20
Value	92

Population analysed: Per protocol

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Finacea	0 of 20 (0%)	0 of 20 (0%)	Not reported

Limitations and caveats (from the sponsor): This is an open-label study with a small number of subjects.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acne Vulgaris

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
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RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leon H. Kircik, M.D. principal investigator

DermResearch, PLLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Azelaic acid in people with Acne Vulgaris and Post Inflammatory Hyperpigmentation, run by Derm Research, PLLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment) (time frame: Baseline to 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01038869.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2012.