Acne VulgarisPhase 4NCT02524665

8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne

A Phase 4 study testing MAXCLARITY II (2.5% BPO) Foam Cleanser, MAXCLARITY II (2.5% BPO) Foam Treatment and MAXCLARITY II (0.5% Salicylic Acid) Toner Foam in people with Acne Vulgaris, run by Stiefel, a GSK Company.

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

Who is it for?: Ages 16 to 29 years
Conditions the study is for: Acne Vulgaris
What is being tested?: MAXCLARITY II (2.5% BPO) Foam Cleanser, MAXCLARITY II (2.5% BPO) Foam Treatment and MAXCLARITY II (0.5% Salicylic Acid) Toner Foam
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: No sites listed yet
Study dates: Sep 2009to Dec 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 16 to 29 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.
Male or female aged from 16 to 29 years, inclusive, at time of consent. No more than 50% of the subjects at each site can be enrolled under the age of 20.
Mild facial acne, characterized by at least 12 facial inflammatory lesions (papules and pustules) and/or noninflammatory lesions (open and closed comedones) on each half of the face (excluding nose and front hairline areas).
Able to complete the study and to comply with study instructions.
Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Acceptable contraceptive methods include the following:
Hormonal contraception, including oral, injectable, or implantable methods started at least 2 months prior to screening. If hormonal contraception was started less than 2 months prior to screening, then a form of nonhormonal contraception should be added until the third continuous month of hormonal contraception has been completed.
Two forms of reliable nonhormonal contraception, to include the use of either an intrauterine device plus a reliable barrier method or 2 reliable barrier methods. Reliable barrier methods include condoms or diaphragms. A cervical cap is also a reliable barrier method, provided that the female subject has never given birth naturally. The combined use of a condom and spermicide constitute 2 forms of acceptable nonhormonal contraception, provided that they are both used properly. The use of spermicide alone and the improper use of condoms are inferior methods of contraception. Subjects with surgical sterilization, including tubal sterilization or partner's vasectomy, must use a form of nonhormonal contraception. A barrier method or sterilization plus spermatocide is acceptable.
Women who are not currently sexually active must agree to use a medically accepted method of contraception should she become sexually active while participating in the study.

Who cannot join

Female who is pregnant, trying to become pregnant, or breast feeding.
Has an active or chronic skin allergy.
Has a history of acute or chronic disease that might interfere with or increase the risk of study participation.
Had skin cancer treatment in preceding 12 months.
Has damaged skin on facial areas (eg, sunburn, tattoo, or scar)
Had any medical procedure (eg, laser resurfacing, chemical peel, or plastic surgery) on facial areas in preceding 12 months.

Show all 14Show fewer

Had any cosmetic procedure (eg, microdermabrasion) on facial areas within 8 weeks of the baseline visit.
Has any dermatological disorder that in the opinion of the investigator may interfere with the accurate evaluation of the subject's facial appearance.
Received any investigational drug or procedure within 28 days of the baseline visit.
Currently using any medication that in the opinion of the investigator may affect the evaluation of the study products or place the subject at undue risk.
Has a history of known or suspected intolerance to any of the ingredients of the study products (ie, benzoyl peroxide).
Considered unable or unlikely to attend the necessary visits.
Live in the same household as currently enrolled subjects.
Employee of the investigator, a contract research organization, or Stiefel Laboratories who is involved in the study, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee involved in the study.

About this study

Official title: U0289-404: An Evaluator Blinded, 8 Week, Split Face Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITYII and MURAD in Subjects With Acne

One of the main success factors in acne therapy is user compliance with treatment, product cost, availability and ease of use. Poor compliance may translate into decreased efficacy (either not improving symptoms well enough or not improving symptoms fast enough), tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a lack of understanding of the instructions for use, or product cost/availability. Whatever the reason, poor compliance translates to decreased efficacy and increased frustration on the part of the user.

The current study will evaluate and compare the efficacy and tolerability of 2 over the counter, topical product lines for the treatment of acne: MAXCLARITY II Foam Cleanser (2.5% benzoyl peroxide [BPO]) plus Foam Treatment (2.5% BPO) and (0.5% Salicylic Acid) Toner Foam compared with MURAD Clarifying Cleanser (1.5% salicylic acid [SA]) plus Exfoliating Acne Treatment Gel (1% SA) and Skin Perfecting Lotion.

Read the detailed description

Acne vulgaris (acne) is an extremely common dermatological disease that is found typically in adolescence and young adulthood. Acne manifests with open and closed comedones (blackheads and whiteheads), papules, pustules, nodules, and cysts on the face, neck, and trunk. Acne can be treated with a variety of agents that are selected to address the pathogenic factors assumed to be responsible for the type and degree of manifested acne lesions. Monotherapy and combination therapy regimens are both useful. Topical agents are generally used as first-line therapy and include retinoids, antibiotic preparations (eg, erythromycin and clindamycin), benzoyl peroxide (BPO), alpha and beta hydroxy acids (eg, glycolic and salicylic acid [SA] preparations), and azelaic acid. Systemic therapies are initiated in patients with moderate to severe inflammatory acne that does not respond to topical therapy.

Benzoyl peroxide has antimicrobial and anti inflammatory properties and is often considered an important component of acne treatment. Salicylic acid has comedolytic properties and is often used when other topical therapies are not tolerated. Benzoyl peroxide and SA are frequently the first products that adolescents will use for acne because both can be purchased without a prescription in several different concentrations and formulations.

The current study will evaluate and compare the efficacy and tolerability of 2 over the counter, topical product lines for the treatment of acne: MAXCLARITY II Foam Cleanser (2.5% benzoyl peroxide [BPO]) plus Foam Treatment (2.5% BPO) and (0.5% Salicylic Acid) Toner Foam compared with MURADClarifying Cleanser (1.5% salicylic acid [SA]) plus Exfoliating Acne Treatment Gel (1% SA) and Skin Perfecting Lotion.

This is a randomized, single center, evaluator blinded, split face efficacy and tolerability study of MaxClarity II and Murad, 2 over the-counter, topical product lines for the treatment of acne. Approximately 20 subjects, aged from 16 to 29 years, inclusive, with mild facial acne are expected to participate in the study. No more than 50% of the subjects at each site can be enrolled under the age of 20.

An expert grader (blinded evaluator) will complete counts of inflamed lesions (papules/pustules) and noninflamed lesions (open/closed comedones), the ISGA, and an assessment of tolerability of each side of the face at each study visit. Subjects will assess tolerability on each side of the face at each study visit and will complete a product acceptability and preference questionnaire at the end of the study.

The study duration will be 8 weeks (56 days) with visits at baseline (day 1), week 1, week 2, week 4 and week 8. Only the expert grader (evaluator) will be blinded to the study product assignments; subjects and study nurses/coordinators will not be blinded.

Conditions: Acne Vulgaris
Being tested: MAXCLARITY II (2.5% BPO) Foam Cleanser, MAXCLARITY II (2.5% BPO) Foam Treatment, MAXCLARITY II (0.5% Salicylic Acid) Toner Foam, MURAD Clarifying Cleanser (1.5% SA), Exfoliating Acne Treatment Gel (1% SA)
Medical subject headings: Acne Vulgaris

What participants receive

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

MAXCLARITY II (2.5% BPO) Foam CleanserOther
Available over the counter.
MAXCLARITY II (2.5% BPO) Foam TreatmentOther
Available over the counter.
MAXCLARITY II (0.5% Salicylic Acid) Toner FoamOther
Available over the counter.
MURAD Clarifying Cleanser (1.5% SA)Other
Available over the counter.
Exfoliating Acne Treatment Gel (1% SA)Other
Available over the counter.
Skin Perfecting LotionOther
Available over the counter.

Study groups in NCT02524665
Study group	Role	What they receive
MAXCLARITY II	Experimental	MAXCLARITY II Foam Cleanser (2.5% BPO) plus Foam Treatment (2.5% BPO) and (0.5% Salicylic Acid) Toner Foam. Available over the counter. Each subject applies both arms (MAXCLARITY II and MURAD) simultaneously for the entire duration of the study (8 weeks), each arm to be applied to one side of the face only (split-face study) according to randomization. Receives: Other: MAXCLARITY II (2.5% BPO) Foam Cleanser; Other: MAXCLARITY II (2.5% BPO) Foam Treatment; Other: MAXCLARITY II (0.5% Salicylic Acid) Toner Foam
MURAD	Active comparator	MURADClarifying Cleanser (1.5% SA) plus Exfoliating Acne Treatment Gel (1% SA) and Skin Perfecting Lotion. Available over the counter. Each subject applies both arms (MAXCLARITY II and MURAD) simultaneously for the entire duration of the study (8 weeks), each arm to be applied to one side of the face only (split-face study) according to randomization. Receives: Other: MURAD Clarifying Cleanser (1.5% SA); Other: Exfoliating Acne Treatment Gel (1% SA); Other: Skin Perfecting Lotion

What is being measured

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

Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 8.
During each study visit, expert grader (blinded evaluator) assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open [blackheads] and closed [whiteheads] comedones) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 8 was calculated as the value at Week 8 minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1.
Measured: Baseline and Week 8

Secondary outcomes (5)

Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 1, 2 and 4.
During each study visit, expert grader (blinded evaluator) assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1.
Measured: Baseline and Week 1, 2, 4
Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Week 1, 2, 4 and 8
During each study visit, investigators/expert grader evaluated the acne severity of participants' faces using the ISGA scale on right and left side of face on a five point scale from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1.
Measured: Baseline and Week 1, 2, 4, 8
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1.
Measured: Baseline and Week 1, 2, 4, 8
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Redness, dryness, burning, itching and scaling were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1.
Measured: Baseline and Week 1, 2, 4, 8
Percentage of Participant Who Improved by at Least One Grade on the ISGA
During each study visit, investigators/expert grader evaluated the acne severity of participants' faces using the ISGA scale on right and left side of face on a five point scale from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Percent change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1.
Measured: Up to Week 8

Timeline

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

Sep 2009Dec 2009

First posted17 Aug 2015 (estimated)
Study startSep 2009
Primary completionDec 2009
Study completionDec 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: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02524665
Sponsor's protocol ID: 114553
Status last verified: Jan 2017
First submitted: 13 Aug 2015
Last updated: 13 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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?

Official record

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

All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: U0289-404: An Evaluator Blinded, 8 Week, Split Face Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITYII and MURAD in Subjects With Acne
ClinicalTrials.gov ID: NCT02524665
Acronym / sponsor ID: 114553
Conditions: Acne Vulgaris
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 17 Aug 2015 (estimated)
Results: Posted 15 Mar 2017

Clinical summary

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

Detailed description

The current study will evaluate and compare the efficacy and tolerability of 2 over the counter, topical product lines for the treatment of acne: MAXCLARITY II Foam Cleanser (2.5% benzoyl peroxide [BPO]) plus Foam Treatment (2.5% BPO) and (0.5% Salicylic Acid) Toner Foam compared with MURADClarifying Cleanser (1.5% salicylic acid [SA]) plus Exfoliating Acne Treatment Gel (1% SA) and Skin Perfecting Lotion.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
MAXCLARITY II	Experimental	Other: MAXCLARITY II (2.5% BPO) Foam Cleanser, Other: MAXCLARITY II (2.5% BPO) Foam Treatment, Other: MAXCLARITY II (0.5% Salicylic Acid) Toner FoamMAXCLARITY II Foam Cleanser (2.5% BPO) plus Foam Treatment (2.5% BPO) and (0.5% Salicylic Acid) Toner Foam. Available over the counter. Each subject applies both arms (MAXCLARITY II and MURAD) simultaneously for the entire duration of the study (8 weeks), each arm to be applied to one side of the face only (split-face study) according to randomization.
MURAD	Active comparator	Other: MURAD Clarifying Cleanser (1.5% SA), Other: Exfoliating Acne Treatment Gel (1% SA), Other: Skin Perfecting LotionMURADClarifying Cleanser (1.5% SA) plus Exfoliating Acne Treatment Gel (1% SA) and Skin Perfecting Lotion. Available over the counter. Each subject applies both arms (MAXCLARITY II and MURAD) simultaneously for the entire duration of the study (8 weeks), each arm to be applied to one side of the face only (split-face study) according to randomization.

Who may qualify

Ages: 16 to 29 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

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.
Male or female aged from 16 to 29 years, inclusive, at time of consent. No more than 50% of the subjects at each site can be enrolled under the age of 20.
Mild facial acne, characterized by at least 12 facial inflammatory lesions (papules and pustules) and/or noninflammatory lesions (open and closed comedones) on each half of the face (excluding nose and front hairline areas).
Able to complete the study and to comply with study instructions.
Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Acceptable contraceptive methods include the following:

Key exclusion criteria (14 listed)

Female who is pregnant, trying to become pregnant, or breast feeding.
Has an active or chronic skin allergy.
Has a history of acute or chronic disease that might interfere with or increase the risk of study participation.
Had skin cancer treatment in preceding 12 months.
Has damaged skin on facial areas (eg, sunburn, tattoo, or scar)

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
MAXCLARITY II (2.5% BPO) Foam CleanserAvailable over the counter.	Other	MAXCLARITY II
MAXCLARITY II (2.5% BPO) Foam TreatmentAvailable over the counter.	Other	MAXCLARITY II
MAXCLARITY II (0.5% Salicylic Acid) Toner FoamAvailable over the counter.	Other	MAXCLARITY II
MURAD Clarifying Cleanser (1.5% SA)Available over the counter.	Other	MURAD
Exfoliating Acne Treatment Gel (1% SA)Available over the counter.	Other	MURAD
Skin Perfecting LotionAvailable over the counter.	Other	MURAD

Primary outcome

Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 8.
Time frame: Baseline and Week 8
During each study visit, expert grader (blinded evaluator) assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open [blackheads] and closed [whiteheads] comedones) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 8 was calculated as the value at Week 8 minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1.

5 secondary outcomes

Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 1, 2 and 4.
Time frame: Baseline and Week 1, 2, 4
Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Week 1, 2, 4 and 8
Time frame: Baseline and Week 1, 2, 4, 8
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Time frame: Baseline and Week 1, 2, 4, 8
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Time frame: Baseline and Week 1, 2, 4, 8
Percentage of Participant Who Improved by at Least One Grade on the ISGA
Time frame: Up to Week 8

Results and safety

Results posted to the registry on 15 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MAXCLARITY II + Murad	20	19

Primary outcome: Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 8.

Time frame: Baseline and Week 8. Mean (Standard Deviation). Unit: Percent change

Measure	MAXCLARITY II n = 20	Murad n = 20
Inflammatory lesion counts- Week 8, n=19, 17	-78.70 (40.93)	-61.52 (47.59)
Non-inflammatory lesion counts- Week 8, n=19, 19	-69.32 (48.69)	-77.09 (23.50)
Total lesion counts-Week 8, n=19, 19	-76.67 (30.79)	-75.01 (23.22)

MAXCLARITY II vs Murad: Mean Difference (Final Values): -14.67, p = 0.0769, Wilcoxon signed-rank test
MAXCLARITY II vs Murad: Mean Difference (Final Values): 7.77, p = 0.6698, Wilcoxon signed-rank test
MAXCLARITY II vs Murad: Mean Difference (Final Values): -1.66, p = 0.6854, t-test, 2 sided

Population analysed: Intent-to-treat (ITT) analysis set was used which included data from all randomized participants who received study product. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MAXCLARITY II + Murad	0 of 20 (0%)	10 of 20 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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
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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

Questions about this trial

What is this clinical trial studying?

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 14 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 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

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 15 Mar 2017). 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?

Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 8. (time frame: Baseline and Week 8). 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 NCT02524665.

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 13 Apr 2017.