Trial · NCT01706263
U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne
NCT01706263, Phase 4, Completed, Stiefel, a GSK Company; results first posted 2018-01-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne. Trials, record NCT01706263. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01706263
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne
- NCT number
- NCT01706263
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 28 participants, actual
- Lead sponsor
- Stiefel, a GSK Company
- Conditions
- Acne Vulgaris
- Interventions
- MAXCLARITY II (2.5% BPO) Foam Cleanser, MAXCLARITY II (2.5% BPO) Foam Treatment, MAXCLARITY II (0.5% Salicylic Acid) Toner Foam
- First posted
- 2012-10-15
- Last updated
- 2018-01-08
- Results first posted
- 2018-01-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8 | Baseline (Day 1) and Week 8 | Evaluator assessed the left 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 (sum of inflammatory and non-inflammatory lesion) 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 was defined as Day 1 value . |
| Secondary | Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4 | Baseline (Day 1) and Week 1, 2, 4 | 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 was calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to specified time (Weeks 1, 2, and 4) point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value . |
| Secondary | Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Weeks 1, 2, 4 and 8 | Baseline (Day 1) and Week 1, 2, 4, 8 | Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value . |
| Secondary | Percentage of Participants Who Improved by at Least One Grade on the ISGA | Up to Week 8 | Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Percent change from Baseline to specified time point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value . |
| Secondary | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8. | Baseline (Day 1) and Week 1, 2, 4, 8 | Erythema , dryness, and peeling, were evaluated independently by the investigator on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value . |
| Secondary | Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8 | Baseline (Day 1) and Week 1, 2, 4, 8 | Redness, dryness, burning, itching and scaling were evaluated independently by the participant on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value . |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8 | Baseline (Day 1) and Week 8 | Intent-to-treat analysis set was used which included data from all randomized participants who received study product. | Percent change | MEAN |
| SECONDARY | Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4 | Baseline (Day 1) and Week 1, 2, 4 | Intent-to-treat analysis set. | Percent change | MEAN |
| SECONDARY | Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Weeks 1, 2, 4 and 8 | Baseline (Day 1) and Week 1, 2, 4, 8 | Intent-to-treat analysis set. | Score on a scale | MEAN |
| SECONDARY | Percentage of Participants Who Improved by at Least One Grade on the ISGA | Up to Week 8 | Intent-to-treat analysis set. | Percentage of participants | NUMBER |
| SECONDARY | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8. | Baseline (Day 1) and Week 1, 2, 4, 8 | Intent-to-treat analysis set. | Score on scale | MEAN |
| SECONDARY | Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8 | Baseline (Day 1) and Week 1, 2, 4, 8 | Intent-to-treat analysis set. | Score on scale | MEAN |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8 | MAXCLARITY II | Inflammatory lesion count | -62.1 | Standard Deviation 37.1 | Percent change |
| Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8 | MAXCLARITY II | Non-Inflammatory lesion count | -49.8 | Standard Deviation 39.7 | Percent change |
| Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8 | MAXCLARITY II | Total lesion count | -56.9 | Standard Deviation 32.7 | Percent change |
| Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4 | MAXCLARITY II | Inflammatory lesion count, Week 1 | -27.9 | Standard Deviation 29.8 | Percent change |
| Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4 | MAXCLARITY II | Inflammatory lesion count, Week 2 | -50.8 | Standard Deviation 25.6 | Percent change |
| Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4 | MAXCLARITY II | Inflammatory lesion count, Week 4 | -49.5 | Standard Deviation 30.6 | Percent change |
| Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4 | MAXCLARITY II | Non-Inflammatory lesion count, Week 1 | -9.9 | Standard Deviation 45.1 | Percent change |
| Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4 | MAXCLARITY II | Non-Inflammatory lesion count, Week 2 | -23.4 | Standard Deviation 38.0 | Percent change |
| Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4 | MAXCLARITY II | Non-Inflammatory lesion count, Week 4 | -34.3 | Standard Deviation 37.5 | Percent change |
| Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4 | MAXCLARITY II | Total lesion count, Week 1 | -22.6 | Standard Deviation 27.6 | Percent change |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MAXCLARITY II | 28 | |
| Overall Study | COMPLETED | MAXCLARITY II | 28 | |
| Overall Study | NOT COMPLETED | MAXCLARITY II | 0 |
Source ClinicalTrials.gov
Adverse events11
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hiatus hernia | Gastrointestinal disorders | MAXCLARITY II | 1 | 28 | |
| other | Application Site Burning | General disorders | MAXCLARITY II | 1 | 28 | |
| other | Bronchitis | Infections and infestations | MAXCLARITY II | 2 | 28 | |
| other | Influenza | Infections and infestations | MAXCLARITY II | 3 | 28 | |
| other | Nasopharyngitis | Infections and infestations | MAXCLARITY II | 5 | 28 | |
| other | Pneumonia | Infections and infestations | MAXCLARITY II | 1 | 28 | |
| other | Sinusitis | Infections and infestations | MAXCLARITY II | 1 | 28 | |
| other | Skin Laceration | Injury, poisoning and procedural complications | MAXCLARITY II | 1 | 28 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | MAXCLARITY II | 1 | 28 | |
| other | Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MAXCLARITY II | 1 | 28 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MAXCLARITY II | 0 | 28 |
| Total, other adverse events | MAXCLARITY II | 11 | 28 |
| Total, serious adverse events | MAXCLARITY II | 0 | 28 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01706263
GET https://conductscience.org/api/trials/v1/NCT01706263/results?page=2