Acne VulgarisPhase 2NCT00594425

Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne

A Phase 2 study testing Methyl aminolevulinate (MAL) PDT in people with Acne Vulgaris, run by Photocure at 14 sites 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

Who is it for?: Ages 15 to 40 years
Conditions the study is for: Acne Vulgaris
What is being tested?: Methyl aminolevulinate (MAL) PDT
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 14 sitesUnited States
Study dates: Feb 2007to Sep 2008
Phase: Phase 2
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 15 to 40 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Female and male patients, age 15 to 40 years with moderate to severe facial acne vulgaris (IGA score 3-4).
Patients with skin type I to IV (Fitzpatrick).
Patients with 20 to 100 inflammatory lesions (papules, pustules, and nodules) on the face excluding lesions on the nose and in the peri-ocular area.
Patients with up to 200 noninflammatory lesions (open and closed comedones) on the face.
Patients with no more than 2 nodular lesions on the face.
Patients who are surgically sterile, postmenopausal, abstinent, or willing to use an adequate means of contraception including birth control pills, or barrier methods and spermicide for at least 14 days prior to Day 0. Patients using birth control pills must have used the same product and dose for at least 6 months and must agree to stay with the same product and dose for an additional 6 months.

Show all 9Show fewer

Patients must be willing and capable of following study instructions to the extent and degree required by the protocol.
Patients must sign the approved informed consent form prior to any study procedures.
Patients must be willing to be photographed. Patients must be willing to sign a photography consent form.

Who cannot join

Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.
Participation in other clinical studies either concurrently or within the last 30 days.
Patients who have a condition or who are in a situation, which, in the investigator's opinion, may put the patient at risk, may confound the study results, or may interfere with the patient's participation in the study.
Clinically significant sensitivity to visible light, or has porphyria or porphyrin sensitivity.
Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within the last 30 days.
Patients with a washout period for topical treatments for their acne of less than 14 days. Medicated cleansers may be used during the washout period and stopped before the treatment.

Show all 9Show fewer

Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month.
Patients with a washout period for oral isotretinoin of less than 6 months.
Patients with a beard or other facial hair that might interfere with study assessments.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Michigan Center for Research Corp
Clinton Twp, Michigan, 48038
Dermatology Treatment & Research
Dallas, Texas, 75230
Suzanne Bruce and Associates, PA
Houston, Texas, 77056
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501-1604
DuPage Medical Group
Naperville, Illinois, 60563
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Central Sooner Research
Norman, Oklahoma, 73069
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Dermatology Associates of Rochester
Rochester, New York, 14623
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124
The Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Therapeutics Clinical Research
San Diego, California, 92123
Solano Clinical Research
Vallejo, California, 94589

Other trials in United States

About this study

This multicenter study will be divided into 2 phases. The first phase will be an open label, dose-escalation phase, while the second will be a blinded, randomized, vehicle-controlled, parallel-group, dose-response phase. The second phase will only start if the first phase succeeds in establishing well tolerated dose(s). Patients with moderate to severe acne vulgaris in the face will be included.The results from part 2 has been presented in the result section.

Read the detailed description

For the second part: All patients will receive 4 PDT sessions 2 weeks apart using a light dose of 37 J/cm2. One treatment group will receive vehicle cream, while the other 2 groups will receive MAL cream with a concentration of 40 mg/g and 80 mg/g, respectively. The MAL and vehicle cream will be applied in a thin layer on clean skin and left for 1.5 hours under occlusion before illumination.

Conditions: Acne Vulgaris
Being tested: Methyl aminolevulinate (MAL) PDT
Medical subject headings: Acne Vulgaris

What participants receive

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

Methyl aminolevulinate (MAL) PDTDrug
Cream application followed by illumination with red light

Study groups in NCT00594425
Study group	Role	What they receive
1	Experimental	PDT using MAL concentration A Receives: Drug: Methyl aminolevulinate (MAL) PDT
2	Experimental	PDT using MAL concentration B Receives: Drug: Methyl aminolevulinate (MAL) PDT
3	Placebo comparator	PDT using Placebo cream Receives: Drug: Methyl aminolevulinate (MAL) PDT

What is being measured

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

Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment
Measured: 12 weeks after last treatment
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts
Measured: 12 weeks after last treatment
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Measured: 12 weeks

Secondary outcomes (31)

Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Measured: 3 weeks after last treatment
Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Measured: 6 weeks after last treatment
Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline
Measured: 6 weeks after last treatment
Percent Reduction in Total Lesion Counts From Baseline
Measured: 6 weeks after last treatment
Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment
Measured: 6 weeks after last treatment
The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment
Measured: 12 weeks after last treatment
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Measured: immediately after illumination-first treatment
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Measured: immediately after second treatment
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Measured: immediately after third treatment
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Measured: immediately after illumination-fourth treatment treatment
Proportion of Patients With Mild and Moderate Erythema After First Treatment
Measured: immediately after first treatment
Proportion of Patients With Mild and Moderate Erythema After First Treatment
Measured: 2 days after first treatment
Proportion of Patients With Mild and Moderate Erythema After Second Treatment
Measured: immediately after second treatment
Proportion of Patients With Mild and Moderate Erythema After Third Treatment
Measured: immediately after third treatment
Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment
Measured: immediately after fourth treatment
Proportion of Patients With Severe Erythema After First Treatment
Measured: immediately after first treatment
Proportion of Patients With Severe Erythema 2 Days After First Treatment
Measured: 2 days after first treatment
Proportion of Patients With Severe Erythema 7 Days After First Treatment
Measured: 7 days after first treatment
Proportion of Patients With Severe Erythema After Second Treatment
Measured: immediately after second treatment
Proportion of Patients With Severe Erythema After Third Treatment
Measured: immediately after third treatment
Proportion of Patients With Severe Erythema After Fourth Treatment
Measured: immediately after fourth treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
Measured: 2 days after treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
Measured: 2 weeks after first treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Measured: 2 weeks after last treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Measured: 6 weeks after last treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Measured: 12 weeks after last treatment
Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
Measured: 2 days after first treatment
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Measured: 2 weeks after last treatment
Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
Measured: 2 weeks after first treatment
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Measured: 6 weeks after last treatment
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Measured: 12 weeks after last treatment

Timeline

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

Feb 2007Sep 2008

First posted15 Jan 2008 (estimated)
Study startFeb 2007
Primary completionJul 2008
Study completionSep 2008

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00594425
Sponsor's protocol ID: PC TA202B/06
Status last verified: Aug 2013
First submitted: 3 Jan 2008
Last updated: 8 Aug 2013
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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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne
ClinicalTrials.gov ID: NCT00594425
Acronym / sponsor ID: PC TA202B/06
Conditions: Acne Vulgaris
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: PhotocureIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Jul 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 15 Jan 2008 (estimated)
Results: Posted 8 Aug 2013

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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: Methyl aminolevulinate (MAL) PDTPDT using MAL concentration A
2	Experimental	Drug: Methyl aminolevulinate (MAL) PDTPDT using MAL concentration B
3	Placebo comparator	Drug: Methyl aminolevulinate (MAL) PDTPDT using Placebo cream

Who may qualify

Ages: 15 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (9 listed)

Female and male patients, age 15 to 40 years with moderate to severe facial acne vulgaris (IGA score 3-4).
Patients with skin type I to IV (Fitzpatrick).
Patients with 20 to 100 inflammatory lesions (papules, pustules, and nodules) on the face excluding lesions on the nose and in the peri-ocular area.
Patients with up to 200 noninflammatory lesions (open and closed comedones) on the face.
Patients with no more than 2 nodular lesions on the face.

Key exclusion criteria (9 listed)

Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.
Participation in other clinical studies either concurrently or within the last 30 days.
Patients who have a condition or who are in a situation, which, in the investigator's opinion, may put the patient at risk, may confound the study results, or may interfere with the patient's participation in the study.
Clinically significant sensitivity to visible light, or has porphyria or porphyrin sensitivity.
Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within the last 30 days.

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
Methyl aminolevulinate (MAL) PDTCream application followed by illumination with red light	Drug	1, 2, 3

Primary outcome

Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment
Time frame: 12 weeks after last treatment
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts
Time frame: 12 weeks after last treatment
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Time frame: 12 weeks

31 secondary outcomes

Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Time frame: 3 weeks after last treatment
Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Time frame: 6 weeks after last treatment
Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline
Time frame: 6 weeks after last treatment
Percent Reduction in Total Lesion Counts From Baseline
Time frame: 6 weeks after last treatment
Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment
Time frame: 6 weeks after last treatment
The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment
Time frame: 12 weeks after last treatment
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Time frame: immediately after illumination-first treatment
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain
Time frame: immediately after second treatment
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Time frame: immediately after third treatment
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Time frame: immediately after illumination-fourth treatment treatment
Proportion of Patients With Mild and Moderate Erythema After First Treatment
Time frame: immediately after first treatment
Proportion of Patients With Mild and Moderate Erythema After First Treatment
Time frame: 2 days after first treatment
Proportion of Patients With Mild and Moderate Erythema After Second Treatment
Time frame: immediately after second treatment
Proportion of Patients With Mild and Moderate Erythema After Third Treatment
Time frame: immediately after third treatment
Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment
Time frame: immediately after fourth treatment
Proportion of Patients With Severe Erythema After First Treatment
Time frame: immediately after first treatment
Proportion of Patients With Severe Erythema 2 Days After First Treatment
Time frame: 2 days after first treatment
Proportion of Patients With Severe Erythema 7 Days After First Treatment
Time frame: 7 days after first treatment
Proportion of Patients With Severe Erythema After Second Treatment
Time frame: immediately after second treatment
Proportion of Patients With Severe Erythema After Third Treatment
Time frame: immediately after third treatment
Proportion of Patients With Severe Erythema After Fourth Treatment
Time frame: immediately after fourth treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
Time frame: 2 days after treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
Time frame: 2 weeks after first treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Time frame: 2 weeks after last treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Time frame: 6 weeks after last treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Time frame: 12 weeks after last treatment
Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
Time frame: 2 days after first treatment
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Time frame: 2 weeks after last treatment
Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
Time frame: 2 weeks after first treatment
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Time frame: 6 weeks after last treatment
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Time frame: 12 weeks after last treatment

Results and safety

Results posted to the registry on 8 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
40 mg/g MAL PDT	50	43
80 mg/g MAL PDT	48	34
Vehicle PDT	52	42

Primary outcome: Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment

Time frame: 12 weeks after last treatment. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	40 mg/g MAL PDT n = 50	80 mg/g MAL PDT n = 48	Vehicle PDT n = 52
Value	16 (8.34 to 28.51)	14.58 (7.25 to 27.17)	11.54 (5.40 to 22.97)

40 mg/g MAL PDT vs Vehicle PDT: % success rate: 5.53 (95% CI -7.97 to 19.04), p = 0.5288, Cochran-Mantel-Haenszel
80 mg/g MAL PDT vs Vehicle PDT: % success rate: 3.95 (95% CI -8.79 to 16.69), p = 0.7539, Cochran-Mantel-Haenszel

Population analysed: ITT population

Primary outcome: Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts

Time frame: 12 weeks after last treatment. Least squares mean (95% Confidence Interval). Unit: lesions

Measure	40 mg/g MAL PDT n = 50	80 mg/g MAL PDT n = 48	Vehicle PDT n = 52
Value	-10.72 (-14.45 to -6.99)	-9.27 (-13.25 to -5.3)	-8.08 (-11.8 to -4.6)

40 mg/g MAL PDT vs Vehicle PDT: Least squares mean: -2.64 (95% CI -7.91 to 2.63), p = 0.3236, ANCOVA
80 mg/g MAL PDT vs Vehicle PDT: Least squares mean: -1.19 (95% CI -6.64 to 4.26), p = 0.6657, ANCOVA

Population analysed: ITT population

Primary outcome: Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment

Time frame: 12 weeks after last treatment. Number. Unit: percentage of participants

Measure	40 mg/g MAL PDT n = 42	80 mg/g MAL PDT n = 40	Vehicle PDT n = 33
Value	17.5 (6.72 to 27.84)	21.2 (8.75 to 31.95)	16.7 (10.68 to 37.75)

40 mg/g MAL PDT vs Vehicle PDT: %success rate: 3.09 (95% CI -11.16 to 17.33), p = 0.7889, Cochran-Mantel-Haenszel
80 mg/g MAL PDT vs Vehicle PDT: Percent success: 5.48 (95% CI -10.15 to 21.11), p = 0.8880, Cochran-Mantel-Haenszel

Population analysed: PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).

Primary outcome: Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline

Time frame: 12 weeks. Least squares mean (95% Confidence Interval). Unit: lesions

Measure	40 mg/g MAL PDT n = 42	80 mg/g MAL PDT n = 40	Vehicle PDT n = 33
Value	-10.95 (-15.18 to -6.72)	-11.8 (-16.65 to -6.95)	-10.62 (-15.12 to -6.12)

40 mg/g MAL PDT vs Vehicle PDT: Least squares mean: -0.33 (95% CI -6.53 to 5.86), p = 0.9151, ANCOVA
80 mg/g MAL PDT vs Vehicle PDT: Least squares mean: -1.18 (95% CI -7.81 to 5.45), p = 0.7233, ANCOVA

31 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
40 mg/g MAL PDT	2 of 50 (4%)	50 of 50 (100%)	Not reported
80 mg/g MAL PDT	0 of 48 (0%)	46 of 48 (95.8%)	Not reported
Vehicle PDT	0 of 52 (0%)	38 of 52 (73.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2013.
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.

David Pariser, MD principal investigator

AAD

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Methyl aminolevulinate (MAL) PDT in people with Acne Vulgaris, run by Photocure at 14 sites 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 9 inclusion and 9 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 8 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 8 Aug 2013). 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?

Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment (time frame: 12 weeks after last treatment). The study lists 3 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 NCT00594425.

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 8 Aug 2013.