Acne VulgarisNCT01237821

Comparing OTC Acne Treatment to Prescription Regimen

A study testing BenzaClin and Effaclar in people with Acne Vulgaris, run by Milton S. Hershey Medical Center 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

Search all trials

Trial summary

This research is being done to find out the safety and efficacy of two acne creams, Effaclar and Benzaclin when used twice daily with a topical retinoid. Effaclar and Benzaclin are FDA approved for the treatment of acne. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Acne Vulgaris
What is being tested?: BenzaClin and Effaclar
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteUnited States
Study dates: Oct 2010to Oct 2011
Phase: Interventional
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 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Inclusion Criteria:males and females ages 18-50, mild to moderate acne vulgaris with > or equal to 15 inflammatory lesions, > or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study

Exclusion Criteria:Participants who have another skin condition that will interfere with lesion counting or assessments

Trial locations and contacts

1 site in 1 country.

United States1 site

Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: A MULTI-CENTER, DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF TWO ACNE CREAMS IN SUBJECTS WITH MILD TO MODERATE ACNE VULGARIS

Read the detailed description

There are many products on the market to treat facial acne. The medication that this study will be evaluating, Benzaclin and Retin-A have been approved by the FDA and is available by prescription, Effaclar is an over the counter product. This study will hopefully recognize a treatment combination that is effective in reducing acne vulgaris in adults 18-50.

Conditions: Acne Vulgaris
Being tested: BenzaClin, Effaclar
Medical subject headings: Acne Vulgaris

What participants receive

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

BenzaClinDrug
Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
EffaclarDrug
Topical, Bid, 12 weeks

Study groups in NCT01237821
Study group	Role	What they receive
BenzaClin	Active comparator	Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.Inclusion- males and females ages 18-50, mild to moderate acne vulgaris with > or equal to 15 inflammatory lesions, > or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study, . Exclusion- Participants who have another skin condition that will interfere with lesion counting or assessments Receives: Drug: BenzaClin
effaclar	Active comparator	Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.Inclusion- males and females ages 18-50, mild to moderate acne vulgaris with > or equal to 15 inflammatory lesions, > or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study, . Exclusion- Participants who have another skin condition that will interfere with lesion counting or assessments Receives: Drug: Effaclar

What is being measured

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

Treatment Tolerability Assessment: Erythema
Participants were assessed for Erythema on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Treatment Tolerability Assessment: Edema
Participants were assessed for Edema on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Treatment Tolerability Assessment: Dryness
Participants were assessed for Dryness on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Treatment Tolerability Assessment: Peeling
Participants were assessed for Peeling on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Facial Skin Assessment: Skin Tone (Clarity)
The facial skin was assessed for skin tone (clarity) on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Facial Skin Assessment: Skin Smoothness
The facial skin was assessed for skin smoothness on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Facial Skin Assessment: Skin Brightness
The facial skin was assessed for skin brightness on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Facial Skin Assessment: Appearance of Pores
The facial skin was assessed for the appearance of pores on a 10-point visual analog scale,with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Facial Skin Assessment: Overall Appearance
The facial skin was assessed for overall appearance on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Facial Skin Assessment: Global Acne Assessment
The facial skin was assessed for global acne assessment on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Facial Lesion Counts: Open Comedones
Participants were assessed for facial open comedomes and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Facial Lesion Counts: Closed Comedones
Participants were assessed for facial closed comedomes and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Facial Lesion Counts: Papules
Participants were assessed for facial open comedomes and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Facial Lesion Counts: Pustules
Participants were assessed for facial pustules and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Facial Lesion Counts: Noninflammatory Lesions
Participants were assessed for facial noninflammatory lesions and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Facial Lesion Counts: Inflammatory Lesions
Participants were assessed for facial inflammatory lesions and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Facial Lesion Counts: Total Lesion
Participants were assessed for all facial lesions and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging
Irritation stinging was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling
Irritation tingling was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching
Irritation itching was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks
Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning
Irritation burning was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Measured: 16 weeks

Timeline

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

Oct 2010Oct 2011

First posted10 Nov 2010 (estimated)
Study startOct 2010
Primary completionAug 2011
Study completionOct 2011

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.
More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01237821
Sponsor's protocol ID: CS1007033A
Status last verified: Jun 2019
First submitted: 9 Nov 2010
Last updated: 16 Jul 2019
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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RecruitingPhase 3
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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A MULTI-CENTER, DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF TWO ACNE CREAMS IN SUBJECTS WITH MILD TO MODERATE ACNE VULGARIS
ClinicalTrials.gov ID: NCT01237821
Acronym / sponsor ID: CS1007033A
Conditions: Acne Vulgaris
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Milton S. Hershey Medical CenterUniversity, hospital or other
Collaborators: Loreal USA
Study start: Oct 2010
Primary completion: Aug 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 10 Nov 2010 (estimated)
Results: Posted 16 Jul 2019

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
BenzaClin	Active comparator	Drug: BenzaClinEvaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.Inclusion- males and females ages 18-50, mild to moderate acne vulgaris with > or equal to 15 inflammatory lesions, > or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study, . Exclusion- Participants who have another skin condition that will interfere with lesion counting or assessments
effaclar	Active comparator	Drug: EffaclarEvaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.Inclusion- males and females ages 18-50, mild to moderate acne vulgaris with > or equal to 15 inflammatory lesions, > or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study, . Exclusion- Participants who have another skin condition that will interfere with lesion counting or assessments

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

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
BenzaClinTopical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks	Drug	BenzaClin
EffaclarTopical, Bid, 12 weeks	Drug	effaclar

Primary outcome

Treatment Tolerability Assessment: Erythema
Time frame: 16 weeks
Participants were assessed for Erythema on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Treatment Tolerability Assessment: Edema
Time frame: 16 weeks
Participants were assessed for Edema on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Treatment Tolerability Assessment: Dryness
Time frame: 16 weeks
Participants were assessed for Dryness on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Treatment Tolerability Assessment: Peeling
Time frame: 16 weeks
Participants were assessed for Peeling on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Facial Skin Assessment: Skin Tone (Clarity)
Time frame: 16 weeks
The facial skin was assessed for skin tone (clarity) on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Facial Skin Assessment: Skin Smoothness
Time frame: 16 weeks
The facial skin was assessed for skin smoothness on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Facial Skin Assessment: Skin Brightness
Time frame: 16 weeks
The facial skin was assessed for skin brightness on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Facial Skin Assessment: Appearance of Pores
Time frame: 16 weeks
The facial skin was assessed for the appearance of pores on a 10-point visual analog scale,with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Facial Skin Assessment: Overall Appearance
Time frame: 16 weeks
The facial skin was assessed for overall appearance on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Facial Skin Assessment: Global Acne Assessment
Time frame: 16 weeks
The facial skin was assessed for global acne assessment on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Facial Lesion Counts: Open Comedones
Time frame: 16 weeks
Participants were assessed for facial open comedomes and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Facial Lesion Counts: Closed Comedones
Time frame: 16 weeks
Participants were assessed for facial closed comedomes and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Facial Lesion Counts: Papules
Time frame: 16 weeks
Participants were assessed for facial open comedomes and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Facial Lesion Counts: Pustules
Time frame: 16 weeks
Participants were assessed for facial pustules and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Facial Lesion Counts: Noninflammatory Lesions
Time frame: 16 weeks
Participants were assessed for facial noninflammatory lesions and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Facial Lesion Counts: Inflammatory Lesions
Time frame: 16 weeks
Participants were assessed for facial inflammatory lesions and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Facial Lesion Counts: Total Lesion
Time frame: 16 weeks
Participants were assessed for all facial lesions and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging
Time frame: 16 weeks
Irritation stinging was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling
Time frame: 16 weeks
Irritation tingling was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching
Time frame: 16 weeks
Irritation itching was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning
Time frame: 16 weeks
Irritation burning was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.

Results and safety

Results posted to the registry on 16 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BenzaClin	32	26
Effaclar	34	34

Primary outcome: Treatment Tolerability Assessment: Erythema

Time frame: 16 weeks. Mean (Full Range). Unit: score on a scale

Measure	Effaclar n = 26	Benzaclin n = 34
Baseline	0.3 (0 to 3)	0.4 (0 to 3)
Week 2	0.6 (0 to 3)	0.4 (0 to 3)
Week 4	0.3 (0 to 3)	0.4 (0 to 3)
Week 8	0.1 (0 to 3)	0.2 (0 to 3)
Week 12	0.2 (0 to 3)	0.2 (0 to 3)
Week 16	0.1 (0 to 3)	0.1 (0 to 3)

Population analysed: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.

Primary outcome: Treatment Tolerability Assessment: Edema

Time frame: 16 weeks. Mean (Full Range). Unit: score on a scale

Measure	Effaclar n = 26	Benzaclin n = 34
Baseline	0.1 (0 to 3)	0.1 (0 to 3)
Week 2	0.2 (0 to 3)	0.2 (0 to 3)
Week 4	0.1 (0 to 3)	0.2 (0 to 3)
Week 8	0.0 (0 to 3)	0.1 (0 to 3)
Week 12	0.0 (0 to 3)	0.0 (0 to 3)
Week 16	0.0 (0 to 3)	0.0 (0 to 3)

Primary outcome: Treatment Tolerability Assessment: Dryness

Time frame: 16 weeks. Mean (Full Range). Unit: score on a scale

Measure	Effaclar n = 26	Benzaclin n = 34
Baseline	0.4 (0 to 3)	0.2 (0 to 3)
Week 2	0.9 (0 to 3)	0.7 (0 to 3)
Week 4	0.6 (0 to 3)	0.3 (0 to 3)
Week 8	0.2 (0 to 3)	0.2 (0 to 3)
Week 12	0.2 (0 to 3)	0.2 (0 to 3)
Week 16	0.0 (0 to 3)	0.0 (0 to 3)

Primary outcome: Treatment Tolerability Assessment: Peeling

Time frame: 16 weeks. Mean (Full Range). Unit: score on a scale

Measure	Effaclar n = 26	Benzaclin n = 34
Baseline	0.1 (0 to 3)	0.0 (0 to 3)
Week 2	0.5 (0 to 3)	0.6 (0 to 3)
Week 4	0.5 (0 to 3)	0.3 (0 to 3)
Week 8	0.1 (0 to 3)	0.2 (0 to 3)
Week 12	0.1 (0 to 3)	0.1 (0 to 3)
Week 16	0.0 (0 to 3)	0.0 (0 to 3)

Adverse events

Time frame: 16 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Effaclar	0 of 26 (0%)	0 of 26 (0%)	0 of 26
BenzaClin	0 of 34 (0%)	0 of 34 (0%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Christian Oresajo, PhD study director

Loreal USA

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

Questions about this trial

What is this clinical trial studying?

A study testing BenzaClin and Effaclar in people with Acne Vulgaris, run by Milton S. Hershey Medical Center 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?

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 16 Jul 2019. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2019). 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?

Treatment Tolerability Assessment: Erythema (time frame: 16 weeks). The study lists 21 primary outcomes in all. 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 NCT01237821.

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 16 Jul 2019.