Acne VulgarisPhase 4NCT00926367
Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications
A Phase 4 study testing Clindamycin and benzoyl peroxide and benzoyl peroxide 2.5% and adapalene 0.1% gel in people with Acne Vulgaris, run by Stiefel, a GSK Company at 1 site in United States.
Trial summary
This is a single-blind (blinded expert grader), randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral side of the face will remain non-treated… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Clindamycin and benzoyl peroxide and benzoyl peroxide 2.5% and adapalene 0.1% gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jul 2009
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects 18 to 45 years of age or older, able to complete the study and comply with study instructions.
- Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception
- Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.
- Is willing to discontinue use of all facial products (other than the cleanser provided and makeup or razor and facial shave product) on the face for the 3 days before their baseline/day 0 visit and use only the provided facial products and their normal makeup or razor and facial shaving product for the duration of the study.
- Is willing to avoid sunburn, tanning, tanning beds or other excessive sun exposure. Understands that if their skin tone changes significantly during the study it will be necessary to discontinue their participation.
Who cannot join
- Male subjects that have facial beards (mustache and/or goatee is acceptable).
- Is a Type I diabetic.
- Has active or chronic skin allergies.
- Has a history of acute or chronic disease that might interfere with, or increase the risk of study participation.
- Has participated in other facial studies in the preceding 30 days or other clinical studies in preceding 14 days.
- Had skin cancer treatment in preceding 12 months.
Show all 11Show fewer
- Has damaged skin on facial areas (eg, from sunburn, tattoos, scars).
- Had any medical procedure (eg, laser resurfacing, chemical peels, plastic surgery) to facial areas in preceding 12 months.
- Had any cosmetic procedure (eg, microdermabrasion, etc.) to facial areas within 8 weeks of the baseline visit.
- Live in the same household as currently enrolled subjects.
- Any other condition or factor the investigator or his duly assigned representative believes may affect the skin response or the interpretation of the test results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Topical Antibiotic and Benzoyl Peroxide to Benzoyl Peroxide and Adapalene Topical Gel Acne Medications
This is a single-blind (blinded expert grader), randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product
Read the detailed description
This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, a topical antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product.
The subjects will be entered into a 2-week treatment phase. The once-daily applications for the study medication will be supervised at the site, Monday through Friday of each week. Subjects will apply the study product at home on Saturdays and Sundays.
A blinded expert grader will rate comparative product tolerance on each week day (excluding Saturdays and Sundays) during the study before study product is applied.
Subject questionnaires will be completed along with collection of all adverse events.
- Conditions
- Acne Vulgaris
- Being tested
- Clindamycin and benzoyl peroxide, benzoyl peroxide 2.5% and adapalene 0.1% gel
- Keywords
- Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin and benzoyl peroxideDrug
Also called Duac® Topical Gel (clindamycin and benzoyl peroxide.
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide gel. This contains a topical antibiotic and benzoyl peroxide gel.
benzoyl peroxide 2.5% and adapalene 0.1% gelDrug
Also called benzoyl peroxide gel and adapalene gel
Once-daily applications, to the randomized side of the face either left or right,benzoyl peroxide and adapalene gel
| Study group | Role | What they receive |
|---|---|---|
| Clinidamycin/ Benzoyl Peroxide | Experimental | Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide (BPO). Receives: Drug: Clindamycin and benzoyl peroxide |
| Benzoyl peroxide and adapalene | Active comparator | Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide (BPO) and adapalene Receives: Drug: benzoyl peroxide 2.5% and adapalene 0.1% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Erythema (Redness)
Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.
Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion
Measured: Baseline, Day 1 through Day 14
Skin Dryness
The amount of dryness on the left and right cheek of each panelist.
The scale used to evaluate skin dryness is:
Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring
Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Measured: Baseline, Day 1 through Day 14
Secondary outcomes (16)
Skin Moisture and Hydration
To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale. Higher values indicate greater water loss/ lower skin moisture levels.
Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration. Higher values indicate greater water loss.
Measured: Baseline, Days 3, 7, and 14
Skin Hydration
The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.
Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration.
Measured: Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14
Self Assessment of Burning
The amount of burning on the left and right cheek of each panelist.
The scale used to evaluate burning is:
Scale Description:
(scale: 0 = none to 3 = severe)
Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Measured: Baseline, Day 1 through Day 14
Self Assessment of Stinging
The amount of stinging on the left and right cheek of each panelist.
The scale used to evaluate stinging is:
Scale Description:
(scale: 0 = none to 3 = severe)
Subject Self Assessments of stinging were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Measured: Baseline, Day 1 through Day 14
Self Assessment of Dryness
The amount of dryness on the left and right cheek of each panelist.
The scale used to evaluate dryness is:
Scale Description:
(scale: 0 = none to 3 = severe)
Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Measured: Baseline, Day 1 through Day 14
Self Assessment of Texture (Roughness)
The amount of roughness on the left and right cheek of each panelist.
The scale used to evaluate roughness is:
Scale Description:
(scale: 0 = none to 3 = severe)
Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Measured: Baseline, Day 1 through Day 14
Self Assessment of Pain
The amount of pain on the left and right cheek of each panelist.
The scale used to evaluate pain is:
Scale Description:
(scale: 0 = none to 3 = severe)
Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Measured: Baseline, Day 1 through Day 14
Self Assessment of Crusting
The amount of crusting on the left and right cheek of each panelist.
The scale used to evaluate crusting is:
Scale Description:
(scale: 0 = none to 3 = severe)
Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Measured: Baseline, Day 1 through Day 14
Self Assessment of Blistering
The amount of blistering on the left and right cheek of each panelist.
The scale used to evaluate blistering is:
Scale Description:
(scale: 0 = none to 3 = severe)
Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Measured: Baseline, Day 1 through Day 14
Self Assessment of Oiliness
The amount of oiliness on the left and right cheek of each panelist.
The scale used to evaluate oiliness is:
Scale Description:
(scale: 0 = none to 3 = severe)
Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Measured: Baseline, Day 1 through Day 14
Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?
The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How do you rate the comfort of the skin where you are currently treating with the study product?
The subject replied using the following scale:
- - Very Comfortable
- - Comfortable
- - Somewhat Comfortable
- - Somewhat Uncomfortable
- - Uncomfortable
Measured: Day 14
Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?
The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How compliant were you with applying the study product each and every day?
The subject replied using the following scale:
0 - Not Compliant at all (<50%)
- - Mostly Compliant (50%-79%)
- - Very Compliant (80%-100%)
Measured: Day 14
Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?
The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?
The subject replied using the following scale:
1 - Yes 0 - No
Measured: Day 14
Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?
The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?
The subject replied using the following scale:
0 - Not Applicable
- - Very Easy
- - Easy
- - Neutral
- - Difficult
- - Very Difficult
Measured: Day 14
Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?
The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: What was your overall satisfaction of the study product?
The subject replied using the following scale:
- - Very Satisfied
- - Satisfied
- - Neutral
- - Unsatisfied
- - Very Unsatisfied
Measured: Day 14
Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product?
The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?
The subject replied using the following scale:
0 - Not Applicable
- - Very Easy
- - Easy
- - Neutral
- - Difficult
- - Very Difficult
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2009
- Study completionJul 2009
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiefel, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926367
- Sponsor's protocol ID
- C0000-405
- Status last verified
- May 2015
- First submitted
- 21 Jun 2009
- Last updated
- 20 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Topical Antibiotic and Benzoyl Peroxide to Benzoyl Peroxide and Adapalene Topical Gel Acne Medications
- ClinicalTrials.gov ID
- NCT00926367
- Acronym / sponsor ID
- C0000-405
- Conditions
- Acne Vulgaris
- Keywords
- Acne
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- May 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Posted 4 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-blind (blinded expert grader), randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product
Detailed description
This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, a topical antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product.
The subjects will be entered into a 2-week treatment phase. The once-daily applications for the study medication will be supervised at the site, Monday through Friday of each week. Subjects will apply the study product at home on Saturdays and Sundays.
A blinded expert grader will rate comparative product tolerance on each week day (excluding Saturdays and Sundays) during the study before study product is applied.
Subject questionnaires will be completed along with collection of all adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinidamycin/ Benzoyl Peroxide | Experimental | Drug: Clindamycin and benzoyl peroxideOnce-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide (BPO). |
| Benzoyl peroxide and adapalene | Active comparator | Drug: benzoyl peroxide 2.5% and adapalene 0.1% gelOnce-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide (BPO) and adapalene |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects 18 to 45 years of age or older, able to complete the study and comply with study instructions.
- Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception
- Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.
- Is willing to discontinue use of all facial products (other than the cleanser provided and makeup or razor and facial shave product) on the face for the 3 days before their baseline/day 0 visit and use only the provided facial products and their normal makeup or razor and facial shaving product for the duration of the study.
- Is willing to avoid sunburn, tanning, tanning beds or other excessive sun exposure. Understands that if their skin tone changes significantly during the study it will be necessary to discontinue their participation.
Key exclusion criteria (11 listed)
- Male subjects that have facial beards (mustache and/or goatee is acceptable).
- Is a Type I diabetic.
- Has active or chronic skin allergies.
- Has a history of acute or chronic disease that might interfere with, or increase the risk of study participation.
- Has participated in other facial studies in the preceding 30 days or other clinical studies in preceding 14 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 |
|---|---|---|
| Clindamycin and benzoyl peroxideAlso: Duac® Topical Gel (clindamycin and benzoyl peroxide.Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide gel. This contains a topical antibiotic and benzoyl peroxide gel. | Drug | Clinidamycin/ Benzoyl Peroxide |
| benzoyl peroxide 2.5% and adapalene 0.1% gelAlso: benzoyl peroxide gel and adapalene gelOnce-daily applications, to the randomized side of the face either left or right,benzoyl peroxide and adapalene gel | Drug | Benzoyl peroxide and adapalene |
Primary outcome
Skin Erythema (Redness)
Time frame: Baseline, Day 1 through Day 14
Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below. Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion
Skin Dryness
Time frame: Baseline, Day 1 through Day 14
The amount of dryness on the left and right cheek of each panelist. The scale used to evaluate skin dryness is: Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
16 secondary outcomes
Skin Moisture and Hydration
Time frame: Baseline, Days 3, 7, and 14
Skin Hydration
Time frame: Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14
Self Assessment of Burning
Time frame: Baseline, Day 1 through Day 14
Self Assessment of Stinging
Time frame: Baseline, Day 1 through Day 14
Self Assessment of Dryness
Time frame: Baseline, Day 1 through Day 14
Self Assessment of Texture (Roughness)
Time frame: Baseline, Day 1 through Day 14
Self Assessment of Pain
Time frame: Baseline, Day 1 through Day 14
Self Assessment of Crusting
Time frame: Baseline, Day 1 through Day 14
Self Assessment of Blistering
Time frame: Baseline, Day 1 through Day 14
Self Assessment of Oiliness
Time frame: Baseline, Day 1 through Day 14
Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?
Time frame: Day 14
Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?
Time frame: Day 14
Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?
Time frame: Day 14
Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?
Time frame: Day 14
Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?
Time frame: Day 14
Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product?
Time frame: Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acne Vulgaris
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
Acne Vulgaris, Acne Vulgaris on the Face
Not yet recruiting
A Single-Center, Open-Label Study to Assess the Efficacy and Tolerability of a Brightening Serum in Skin of Color Patients With Post Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Recruiting
Comparison of Topical Clascoterone 1% Cream Versus Adapalene 0.1% Cream in the Treatment of Mild-to-Moderate Acne Vulgaris
Acne Vulgaris
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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Clindamycin and benzoyl peroxide and benzoyl peroxide 2.5% and adapalene 0.1% gel in people with Acne Vulgaris, run by Stiefel, a GSK Company 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 5 inclusion and 11 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 20 May 2015. 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 4 Aug 2011). 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?
Skin Erythema (Redness) (time frame: Baseline, Day 1 through Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2015.