Acne VulgarisPhase 4NCT01706250

U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™

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: 1 Sep 2009to 25 Jan 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

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

Ages 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 vulgaris, characterized by at least 12 facial inflammatory lesions (papules and pustules) and/or noninflammatory lesions (open and closed comedones) on the face.
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 active or chronic skin allergies.
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 or is scheduled to receive an investigational drug (other than the study products) or procedure during the study.
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 (including but not limited to asthma medications, oral steroids, rifampin, anticonvulsants, and St John's wart).
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: U0289-401: An Evaluator Blinded, 8 Week, Split-Face Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and PROACTIV 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 benzoyl peroxide (BPO) product lines in subjects with acne: MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner Foam compared with PROACTIV (2.5% BPO) Renewing Cleanser and Repairing Lotion and Revitalizing Toner.

Read the detailed description

Acne vulgaris is an extremely common dermatological disease that is found typically in adolescence and young adulthood. Acne vulgaris manifests with open and closed comedones (blackheads and whiteheads), papules, pustules, nodules, and cysts on the face, neck, and trunk. Scarring can occur, particularly if the lesions are inflamed and deep, even in the absence of external manipulation (eg, picking and squeezing) of the skin.

Acne vulgaris 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 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. Benzoyl peroxide is frequently the first product that adolescents will use for acne because it 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 common, over-the-counter, topical benzoyl peroxide (BPO) product lines in subjects with acne: MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner Foam compared with PROACTIV(2.5% BPO) Renewing Cleanser and Repairing Lotion and Revitalizing Toner.

This is a randomized, 2 center, evaluator-blinded, split-face efficacy and tolerability study of MAXCLARITYII and PROACTIV, 2 over-the-counter, topical benzoyl peroxide product lines, in subjects with acne. Approximately 40 subjects, aged from 16 to 29 years, inclusive, with mild facial acne vulgaris 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 Investigator's Static Global Assessment (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 1m week 2, week 4 and week 8. Only the expert grader (evaluator) will be blinded to the study product assignments; subjects and study nurses/coordinator 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, PROACTIV (2.5% BPO) Renewing Cleanser, PROACTIV (2.5% BPO) Repairing Lotion
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.
PROACTIV (2.5% BPO) Renewing CleanserOther
Available over the counter.
PROACTIV (2.5% BPO) Repairing LotionOther
Available over the counter.
PROACTIV (2.5% BPO) Revitalizing TonerOther
Available over the counter.

Study groups in NCT01706250
Study group	Role	What they receive
MAXCLARITY II	Experimental	MaxClarity II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner Foam. Available over the counter. Each subject applies both arms (MaxClarity II and Proactiv) 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
PROACTIV	Active comparator	Proactiv (2.5% BPO) Renewing Cleanser and Repairing Lotion and Revitalizing Toner. Available over the counter. Each subject applies both arms (MaxClarity II and Proactiv) 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: PROACTIV (2.5% BPO) Renewing Cleanser; Other: PROACTIV (2.5% BPO) Repairing Lotion; Other: PROACTIV (2.5% BPO) Revitalizing Toner

What is being measured

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

Mean Percent Change in Inflammatory Lesion (IL), Non-inflammatory Lesion (NIL), and Total Lesion (TL) Counts From Baseline (BL) (Day 1) to Week (Wk) 8.
This was an efficacy variable. An expert grader evaluated each side of the face (included forehead, cheeks and chin), the left and the right side, for IL (presence of papules and pustules), NIL (presence of open and closed comedones) and the TLs. The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. The evaluator was also blinded. BL was defined as Day 1. The percent change was calculated as the value at Wk 8 minus the value at BL.
Measured: BL (Day 1) and Wk 8

Secondary outcomes (12)

Mean Percent Change in IL Count From BL (Day 1) to Wks 1, 2 and 4
This was an efficacy variable. An expert grader (blinded) evaluated the left and the right side of the face extending from the hairline to the mandible (included forehead, cheeks and chin). The evaluator assessed the IL by counting the number of papules and pustules. The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. BL was defined as Day 1. The percent change was calculated as the percent value (count of IL) at each individual visit (percent value at wk 1, 2 and 4) minus the value at BL respectively.
Measured: BL (Day1) to Wks 1, 2 and 4
Mean Percent Change in NIL Count From BL (Day 1) to Wks 1, 2 and 4
This was an efficacy variable. An expert grader (blinded) evaluated the left and the right side of the face extending from the hairline to the mandible (included forehead, cheeks and chin). The evaluator assessed the NIL by the presence of open and closed comedones. The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. BL was defined as Day 1. The percent change was calculated as the percent value (count of NIL) at each individual visit (percent value at Wk 1, 2 and 4) minus the value at BL respectively.
Measured: BL (Day 1) to Wks 1, 2 and 4
Mean Percent Change in TL Count From BL (Day 1) to Wks 1, 2 and 4
This was an efficacy variable. An expert grader (blinded) evaluated the left and the right side of the face extending from the hairline to the mandible (included forehead, cheeks and chin). The evaluator assessed the total lesions by the sum of both inflammatory and non-inflammatory lesions on each side (left side and right side). The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. BL was defined as Day 1. The percent change was calculated as the percent value (count of total lesions) at each individual visit (percent value at Wks 1, 2 and 4) minus the value at baseline respectively.
Measured: BL (Day 1) to Wks 1, 2 and 4
Mean Change in Investigator's Static Global Assessment (ISGA) From BL (Day 1) to Wks 1, 2, 4 and 8.
The evaluator (blinded) evaluated the acne severity of the participants' face using the ISGA scale ranging from 0 to 5. The grading was 0= Clear, skin with no IL or NILs; 1= Almost clear, rare NILs with no more than one small IL ; 2= Mild, some NILs with no more than few ILs (papules/pustules only, no nodular lesions); 3= Moderate Upto many NILs and may have some ILs but no more than one small nodular lesion ; 4= Severe, Upto many NILs and ILs but no more than a few nodular lesions; 5= Very severe, many NILS and ILs more than a few nodular lesions, may have cystic lesions. Thus higher score indicated severity of the disease. BL was defined as Day 1. The mean change was calculated as value at each visit (Wks 1,2,4 and 8) minus the value at BL respectively.
Measured: BL (Day 1) to Wks 1, 2, 4 and 8
Mean Change in Each of the Evaluator Tolerability Assessments-Erythema
This was a tolerability variable. The expert grader (blinded evaluator) assessed each left and right side of the face individually at each study visit. The areas on the face excluding nose, nasogenian, and superior and inferior eyelids were evaluated. The evaluator conducting the assessment for the participant remained blinded for the treatment assigned. Erythema is condition characterized by redness or rash on the skin. The assessment of the erythema was graded on 0 to 5 scale based on severity by the evaluator. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated severity of the disease. BL was defined as Day 1. The mean change was calculated as value at each individual visit (wk 1,2,4 and 8) minus the value at BL respectively. The change from BL was '0' for Wk 4 and Wk 8, and hence statistical analysis was not done.
Measured: BL (Day 1) to Wks 1, 2, 4 and 8
Mean Change in Each of the Evaluator Tolerability Assessments-Dryness
This was a tolerability variable. The expert grader (blinded evaluator) assessed each left and right side of the face individually at each study visit. The areas on the face excluding nose, nasogenian, and superior and inferior eyelids were evaluated. The evaluator conducting the assessment for the participant remained blinded for the treatment assigned. The assessment of the dryness was graded on 0 to 5 scale based on severity by the evaluator. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wk 1,2,4 and 8) minus the value at baseline respectively. The change from BL was '0' for Wk 2, Wk 4, and Wk 8 and hence statistical analysis was not done.
Measured: BL (Day 1) to Wks 1, 2, 4 and 8
Mean Change in Each of the Evaluator Tolerability Assessments-Peeling
This was a tolerability variable. The expert grader (blinded evaluator) assessed each left and right side of the face individually at each study visit. The areas on the face excluding nose, nasogenian, and superior and inferior eyelids were evaluated. The evaluator conducting the assessment for the participant remained blinded for the treatment assigned. The assessment of the peeling was graded on 0 to 5 scale based on severity by the evaluator. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wk 1,2,4 and 8) minus the value at BL respectively. The change from BL was '0' for Wk (1, 4 and 8) and hence statistical analysis was not done.
Measured: BL (Day 1) to Wks 1, 2, 4 and 8
Mean Change in Each of the Participant Tolerability Assessments-Redness
This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for redness. The area on the face was assessed excluding the excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the redness was graded on 0 to 5 scale based on severity by the participant. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.
Measured: BL (Day 1) to Wks 1, 2, 4 and 8
Mean Change in Each of the Participant Assessments of Tolerability-Dryness
This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for dryness. The area on the face was assessed excluding the excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the dryness was graded on 0 to 5 scale based on severity by the participant. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated severity of the disease. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.
Measured: BL (Day 1) to Wks 1, 2, 4 and 8
Mean Change in Each of the Participant Assessments of Tolerability-Burning
This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for burning. The area on the face was assessed excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the burning was graded on 0 to 5 scale based on severity by the participant; 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1, 2, 4 and 8) minus the value at BL respectively.
Measured: BL (Day 1) to Wks 1,2, 4 and 8
Mean Change in Each of the Participant Assessments of Tolerability-Itching
This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for itching. The area on the face was assessed excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the itching was graded on 0 to 5 scale based on severity by the participant; 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.
Measured: BL (Day 1) to Wks 1, 2, 4 and 8
Mean Change in Each of the Participant Assessments of Tolerability-Scaling
This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for scaling. The area on the face was assessed excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the scaling was graded on 0 to 5 scale based on severity by the participant; 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.
Measured: BL (Day 1) to Wks 1, 2, 4 and 8

Timeline

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

1 Sep 200925 Jan 2010

First posted15 Oct 2012 (estimated)
Study start1 Sep 2009
Primary completion1 Jan 2010
Study completion25 Jan 2010

Resources

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

More details

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

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01706250
Sponsor's protocol ID: 114550
Status last verified: Apr 2017
First submitted: 11 Oct 2012
Last updated: 23 Aug 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

Not yet recruiting
Evaluating a Brightening Serum for 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
Enrolling by invitationPhase 2/3
A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
Acne
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

All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: U0289-401: An Evaluator Blinded, 8 Week, Split-Face Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and PROACTIV in Subjects With Acne
ClinicalTrials.gov ID: NCT01706250
Acronym / sponsor ID: 114550
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: 1 Sep 2009
Primary completion: 1 Jan 2010 (actual)
Study completion: 25 Jan 2010 (actual)
First posted: 15 Oct 2012 (estimated)
Results: Posted 20 Jun 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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
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 (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner Foam. Available over the counter. Each subject applies both arms (MaxClarity II and Proactiv) 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.
PROACTIV	Active comparator	Other: PROACTIV (2.5% BPO) Renewing Cleanser, Other: PROACTIV (2.5% BPO) Repairing Lotion, Other: PROACTIV (2.5% BPO) Revitalizing TonerProactiv (2.5% BPO) Renewing Cleanser and Repairing Lotion and Revitalizing Toner. Available over the counter. Each subject applies both arms (MaxClarity II and Proactiv) 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 vulgaris, characterized by at least 12 facial inflammatory lesions (papules and pustules) and/or noninflammatory lesions (open and closed comedones) on the face.
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 active or chronic skin allergies.
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
PROACTIV (2.5% BPO) Renewing CleanserAvailable over the counter.	Other	PROACTIV
PROACTIV (2.5% BPO) Repairing LotionAvailable over the counter.	Other	PROACTIV
PROACTIV (2.5% BPO) Revitalizing TonerAvailable over the counter.	Other	PROACTIV

Primary outcome

Mean Percent Change in Inflammatory Lesion (IL), Non-inflammatory Lesion (NIL), and Total Lesion (TL) Counts From Baseline (BL) (Day 1) to Week (Wk) 8.
Time frame: BL (Day 1) and Wk 8
This was an efficacy variable. An expert grader evaluated each side of the face (included forehead, cheeks and chin), the left and the right side, for IL (presence of papules and pustules), NIL (presence of open and closed comedones) and the TLs. The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. The evaluator was also blinded. BL was defined as Day 1. The percent change was calculated as the value at Wk 8 minus the value at BL.

12 secondary outcomes

Mean Percent Change in IL Count From BL (Day 1) to Wks 1, 2 and 4
Time frame: BL (Day1) to Wks 1, 2 and 4
Mean Percent Change in NIL Count From BL (Day 1) to Wks 1, 2 and 4
Time frame: BL (Day 1) to Wks 1, 2 and 4
Mean Percent Change in TL Count From BL (Day 1) to Wks 1, 2 and 4
Time frame: BL (Day 1) to Wks 1, 2 and 4
Mean Change in Investigator's Static Global Assessment (ISGA) From BL (Day 1) to Wks 1, 2, 4 and 8.
Time frame: BL (Day 1) to Wks 1, 2, 4 and 8
Mean Change in Each of the Evaluator Tolerability Assessments-Erythema
Time frame: BL (Day 1) to Wks 1, 2, 4 and 8
Mean Change in Each of the Evaluator Tolerability Assessments-Dryness
Time frame: BL (Day 1) to Wks 1, 2, 4 and 8
Mean Change in Each of the Evaluator Tolerability Assessments-Peeling
Time frame: BL (Day 1) to Wks 1, 2, 4 and 8
Mean Change in Each of the Participant Tolerability Assessments-Redness
Time frame: BL (Day 1) to Wks 1, 2, 4 and 8
Mean Change in Each of the Participant Assessments of Tolerability-Dryness
Time frame: BL (Day 1) to Wks 1, 2, 4 and 8
Mean Change in Each of the Participant Assessments of Tolerability-Burning
Time frame: BL (Day 1) to Wks 1,2, 4 and 8
Mean Change in Each of the Participant Assessments of Tolerability-Itching
Time frame: BL (Day 1) to Wks 1, 2, 4 and 8
Mean Change in Each of the Participant Assessments of Tolerability-Scaling
Time frame: BL (Day 1) to Wks 1, 2, 4 and 8

Results and safety

Results posted to the registry on 20 Jun 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 + PROACTIV	20	18

Primary outcome: Mean Percent Change in Inflammatory Lesion (IL), Non-inflammatory Lesion (NIL), and Total Lesion (TL) Counts From Baseline (BL) (Day 1) to Week (Wk) 8.

Time frame: BL (Day 1) and Wk 8. Mean (Standard Deviation). Unit: percent change in lesion count

Measure	MAXCLARITY II n = 18	PROACTIV n = 18
Percent change, IL count	-55.93 (32.72)	-52.64 (29.23)
Percent change, NIL count	-37.97 (38.72)	-45.66 (23.05)
Percent change in TL count	-45.46 (27.24)	-47.69 (21.92)

MAXCLARITY II vs PROACTIV: Mean Difference (Net): -3.29, p = 0.6779, t-test, 2 sided
MAXCLARITY II vs PROACTIV: Median Difference (Net): 7.68, p = 0.2847, t-test, 2 sided
MAXCLARITY II vs PROACTIV: Median Difference (Net): 2.24, p = 0.6894, t-test, 2 sided

Population analysed: The Intent to treat (ITT) analysis set included data from all randomized participants who received the study drug. The number of participants available at that particular time point were used for analysis.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the informed consent taken to up to 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MAXCLARITY II + PROACTIV	0 of 20 (0%)	5 of 20 (25%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 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.

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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.

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 23 Aug 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 20 Jun 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 Lesion (IL), Non-inflammatory Lesion (NIL), and Total Lesion (TL) Counts From Baseline (BL) (Day 1) to Week (Wk) 8. (time frame: BL (Day 1) and Wk 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 NCT01706250.

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 23 Aug 2017.