NCT01706250 is a Phase 4 clinical trial of MAXCLARITY II (2.5% BPO) Foam Cleanser in Acne Vulgaris, sponsored by Stiefel, a GSK Company.

Who is sponsoring NCT01706250?

NCT01706250 is sponsored by Stiefel, a GSK Company.

What drugs are being tested in NCT01706250?

Interventions in NCT01706250: 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, PROACTIV (2.5% BPO) Revitalizing Toner.

What condition does NCT01706250 study?

NCT01706250 studies Acne Vulgaris.

Is NCT01706250 still recruiting?

NCT01706250 is currently completed. Last updated 23 August 2017.

Are results published for NCT01706250?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-08-23 · How we verify

NCT01706250

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Results posted Last updated 23 August 2017

What this trial tests

Phase 4 trial testing MAXCLARITY II (2.5% BPO) Foam Cleanser in Acne Vulgaris in 20 participants. Completed in 25 January 2010.

Timeline

1 September 2009

Primary endpoint
1 January 2010

25 January 2010

Quick facts

Lead sponsor	Stiefel, a GSK Company
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	1 September 2009
Primary completion	1 January 2010
Estimated completion	25 January 2010

Drugs / interventions tested

MAXCLARITY II (2.5% BPO) Foam Cleanser — full drug profile →
MAXCLARITY II (2.5% BPO) Foam Treatment — full drug profile →
MAXCLARITY II (0.5% Salicylic Acid) Toner Foam — full drug profile →
PROACTIV (2.5% BPO) Renewing Cleanser
PROACTIV (2.5% BPO) Repairing Lotion
PROACTIV (2.5% BPO) Revitalizing Toner

Conditions studied

Acne Vulgaris — all drugs for Acne Vulgaris →

Sponsor

Stiefel, a GSK Company — full company profile →

Who can join

Adults 16 to 29, any sex, with Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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. Primary · 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.

Percent change, IL count

Group	Value	95% CI
MAXCLARITY II	-55.93	± 32.72
PROACTIV	-52.64	± 29.23

Percent change, NIL count

Group	Value	95% CI
MAXCLARITY II	-37.97	± 38.72
PROACTIV	-45.66	± 23.05

Percent change in TL count

Group	Value	95% CI
MAXCLARITY II	-45.46	± 27.24
PROACTIV	-47.69	± 21.92

Mean Percent Change in IL Count From BL (Day 1) to Wks 1, 2 and 4 Secondary · BL (Day1) 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.

Percent change, IL count, BL to Wk 1

Group	Value	95% CI
MAXCLARITY II	-17.56	± 33.63
PROACTIV	-19.93	± 26.39

Percent change, IL count, BL to Wk 2

Group	Value	95% CI
MAXCLARITY II	-35.64	± 37.66
PROACTIV	-31.64	± 30.06

Percent change, IL count, BL to Wk 4

Group	Value	95% CI
MAXCLARITY II	-21.35	± 63.62
PROACTIV	-44.99	± 37.85

Mean Percent Change in NIL Count From BL (Day 1) to Wks 1, 2 and 4 Secondary · 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.

Percent change, NIL count, BL to Wk 1

Group	Value	95% CI
MAXCLARITY II	-3.92	± 32.71
PROACTIV	-7.13	± 25.91

Percent change, NIL count, BL to Wk 2

Group	Value	95% CI
MAXCLARITY II	-24.12	± 37.73
PROACTIV	-21.07	± 26.17

Percent change, NIL count, BL to Wk 4

Group	Value	95% CI
MAXCLARITY II	-30.26	± 38.48
PROACTIV	-37.76	± 22.65

Mean Percent Change in TL Count From BL (Day 1) to Wks 1, 2 and 4 Secondary · 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 th

Percent change, in TL count, BL to Wk 1

Group	Value	95% CI
MAXCLARITY II	-11.34	± 21.84
PROACTIV	-13.36	± 19.07

Percent change, in TL count, BL to Wk 2

Group	Value	95% CI
MAXCLARITY II	-31.94	± 27.86
PROACTIV	-26.19	± 20.23

Percent change, in TL count, BL to Wk 4

Group	Value	95% CI
MAXCLARITY II	-34.17	± 28.06
PROACTIV	-41.17	± 20.23

Mean Change in Investigator's Static Global Assessment (ISGA) From BL (Day 1) to Wks 1, 2, 4 and 8. Secondary · 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 in

Change, in ISGA from BL to Wk 1

Group	Value	95% CI
MAXCLARITY II	-0.10	± 0.31
PROACTIV	-0.05	± 0.39

Change, in ISGA from BL to Wk 2

Group	Value	95% CI
MAXCLARITY II	-0.47	± 0.61
PROACTIV	-0.21	± 0.54

Change, in ISGA from BL to Wk 4

Group	Value	95% CI
MAXCLARITY II	-0.53	± 0.51
PROACTIV	-0.42	± 0.61

Change, in ISGA from BL to Wk 8

Group	Value	95% CI
MAXCLARITY II	-0.39	± 0.61
PROACTIV	-0.39	± 0.61

Mean Change in Each of the Evaluator Tolerability Assessments-Erythema Secondary · BL (Day 1) to Wks 1, 2, 4 and 8

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 h

Erythema; Change from BL to Wk 1

Group	Value	95% CI
MAXCLARITY II	0.05	± 0.51
PROACTIV	-0.05	± 0.22

Erythema; Change from BL to Wk 2

Group	Value	95% CI
MAXCLARITY II	-0.05	± 0.23
PROACTIV	-0.11	± 0.32

Erythema; Change from BL to Wk 4

Group	Value	95% CI
MAXCLARITY II	0.05	± 0.40
PROACTIV	0.05	± 0.40

Erythema; Change from BL to Wk 8

Group	Value	95% CI
MAXCLARITY II	0.06	± 0.42
PROACTIV	0.06	± 0.42

Mean Change in Each of the Evaluator Tolerability Assessments-Dryness Secondary · BL (Day 1) to Wks 1, 2, 4 and 8

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 mea

Dryness; Change from BL to Wk 1

Group	Value	95% CI
MAXCLARITY II	0.15	± 0.49
PROACTIV	0.10	± 0.45

Dryness; Change from BL to Wk 2

Group	Value	95% CI
MAXCLARITY II	0.00	± 0.00
PROACTIV	0.00	± 0.00

Dryness; Change from BL to Wk 4

Group	Value	95% CI
MAXCLARITY II	0.05	± 0.23
PROACTIV	0.00	± 0.00

Dryness; Change from BL to Wk 8

Group	Value	95% CI
MAXCLARITY II	0.11	± 0.32
PROACTIV	0.11	± 0.32

Mean Change in Each of the Evaluator Tolerability Assessments-Peeling Secondary · BL (Day 1) to Wks 1, 2, 4 and 8

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 mea

Peeling; Change from BL to Wk 1

Group	Value	95% CI
MAXCLARITY II	0.00	± 0.00
PROACTIV	0.00	± 0.00

Peeling; Change from BL to Wk 2

Group	Value	95% CI
MAXCLARITY II	0.00	± 0.00
PROACTIV	0.11	± 0.46

Peeling; Change from BL to Wk 4

Group	Value	95% CI
MAXCLARITY II	0.00	± 0.00
PROACTIV	0.00	± 0.00

Peeling; Change from BL to Wk 8

Group	Value	95% CI
MAXCLARITY II	0.00	± 0.00
PROACTIV	0.00	± 0.00

Mean Change in Each of the Participant Tolerability Assessments-Redness Secondary · BL (Day 1) to Wks 1, 2, 4 and 8

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 me

Redness; Change from BL to Wk 1

Group	Value	95% CI
MAXCLARITY II	0.50	± 1.00
PROACTIV	0.35	± 0.81

Redness; Change from BL to Wk 2

Group	Value	95% CI
MAXCLARITY II	0.37	± 1.01
PROACTIV	0.21	± 0.79

Redness; Change from BL to Wk 4

Group	Value	95% CI
MAXCLARITY II	0.72	± 1.13
PROACTIV	0.56	± 0.86

Redness; Change from BL to Wk 8

Group	Value	95% CI
MAXCLARITY II	0.61	± 1.14
PROACTIV	0.28	± 0.75

Mean Change in Each of the Participant Assessments of Tolerability-Dryness Secondary · BL (Day 1) to Wks 1, 2, 4 and 8

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

Dryness; Change from BL to Wk 1

Group	Value	95% CI
MAXCLARITY II	1.20	± 1.24
PROACTIV	0.90	± 1.07

Dryness; Change from BL to Wk 2

Group	Value	95% CI
MAXCLARITY II	1.05	± 1.39
PROACTIV	0.68	± 1.16

Dryness; Change from BL to Wk 4

Group	Value	95% CI
MAXCLARITY II	1.33	± 1.14
PROACTIV	1.06	± 1.00

Dryness; Change from BL to Wk 8

Group	Value	95% CI
MAXCLARITY II	1.33	± 1.24
PROACTIV	1.11	± 1.02

Mean Change in Each of the Participant Assessments of Tolerability-Burning Secondary · BL (Day 1) to Wks 1,2, 4 and 8

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

Burning; Change from BL to Wk 1

Group	Value	95% CI
MAXCLARITY II	0.95	± 1.28
PROACTIV	0.75	± 0.85

Burning; Change from BL to Wk 2

Group	Value	95% CI
MAXCLARITY II	0.84	± 1.17
PROACTIV	0.58	± 0.84

Burning; Change from BL to Wk 4

Group	Value	95% CI
MAXCLARITY II	1.00	± 1.08
PROACTIV	0.44	± 0.62

Burning; Change from BL to Wk 8

Group	Value	95% CI
MAXCLARITY II	0.83	± 1.34
PROACTIV	0.44	± 0.70

Mean Change in Each of the Participant Assessments of Tolerability-Itching Secondary · BL (Day 1) to Wks 1, 2, 4 and 8

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

Itching; Change from BL to Wk 1

Group	Value	95% CI
MAXCLARITY II	0.20	± 0.62
PROACTIV	0.20	± 0.77

Itching; Change from BL to Wk 2

Group	Value	95% CI
MAXCLARITY II	0.37	± 1.01
PROACTIV	0.05	± 0.62

Itching; Change from BL to Wk 4

Group	Value	95% CI
MAXCLARITY II	0.33	± 0.97
PROACTIV	0.06	± 0.24

Itching; Change from BL to Wk 8

Group	Value	95% CI
MAXCLARITY II	0.28	± 0.57
PROACTIV	0.11	± 0.58

Adverse events — posted to ClinicalTrials.gov

Time frame: From the informed consent taken to up to 4 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MAXCLARITY II + PROACTIV

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (4 terms — click to expand)

Reaction	System	MAXCLARITY II + PROACTIV
Nasopharyngitis	Infections and infestations	—
Skin infection	Infections and infestations	—
Headache	Nervous system disorders	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—

Data from ClinicalTrials.gov NCT01706250 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Topical benzoyl peroxide for acne.
Yang Z, Zhang Y, Lazic Mosler E, Hu J, et al · · 2020 · cited 29× · PMID 32175593 · DOI 10.1002/14651858.cd011154.pub2

Verify or expand the search:

Other trials of MAXCLARITY II (2.5% BPO) Foam Cleanser

Trials testing the same drug.

NCT01706263 — U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne · Phase 4 · completed

Other recruiting trials for Acne Vulgaris

Currently open trials in the same condition.

NCT07341087 — Skin Inflammation in Perimenopause: A Probiotic Intervention Proof of Concept Trial · NA · recruiting
NCT07474883 — Efficacy of 0.5% Topical Timolol Eye Drops in the Treatment of Post-Inflammatory Erythema Following Acne Vulgaris · EARLY_PHASE1 · recruiting
NCT07186413 — A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne · Phase 3 · recruiting
NCT07056673 — Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris Study · NA · recruiting
NCT07102186 — Efficacy and Safety of Adapalene Gel and Hyaluronic Acid Versus Adapalene Gel Alone in Mild to Moderate Acne Vulgaris · Phase 4 · recruiting

Other Stiefel, a GSK Company trials

Trials by the same sponsor.

NCT02673619 — A Study to Evaluate Clinical Effect, Pharmacokinetics , Safety, and Tolerability of Umeclidinium in Palmar Hyperhidrosis · Phase 2 · completed
NCT02411162 — A Single Dose Phase I Exploratory Study in Healthy Volunteers With GSK2894512 Cream · Phase 1 · completed
NCT02014584 — Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia · Phase 3 · completed
NCT01984775 — A Study to Evaluate the Irritation Potential of GSK2894512 Cream on Skin in Healthy Subjects · Phase 1 · completed
NCT01446237 — U0289-405: An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, S · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01706250 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stiefel, a GSK Company
Last refreshed: 23 August 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01706250.

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