Trial · NCT02965456
Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
NCT02965456, Phase 3, Completed, Bausch Health Americas, Inc.; results first posted 2019-12-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris. Trials, record NCT02965456. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02965456
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
- NCT number
- NCT02965456
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 820 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Acne
- Interventions
- IDP 121 Lotion, IDP-121 Vehicle Lotion
- First posted
- 2016-11-16
- Last updated
- 2019-12-18
- Results first posted
- 2019-12-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12 | Baseline (Day 0), Week 12 | Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count. |
| Primary | Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12 | Baseline, Week 12 | Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately. |
| Primary | Percentage of Participants With Treatment Success at Week 12 | Baseline, Week 12 | Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. |
| Secondary | Percent Change From Baseline in Noninflammatory Lesion Count to Week 12 | Baseline, Week 12 | Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count. |
| Secondary | Percent Change From Baseline in Inflammatory Lesion Count to Week 12 | Baseline, Week 12 | Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12 | Baseline (Day 0), Week 12 | ITT population included all randomized participants who received study drug. Multiple imputation (Markov Chain Monte Carlo \[MCMC\]) was used to impute missing values. | lesion count | LEAST_SQUARES_MEAN |
| PRIMARY | Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12 | Baseline, Week 12 | ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values. | lesion count | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants With Treatment Success at Week 12 | Baseline, Week 12 | ITT population included all randomized participants who received study drug and evaluable for EGSS score. Multiple imputation (MCMC) was used to impute missing values. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Noninflammatory Lesion Count to Week 12 | Baseline, Week 12 | ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Inflammatory Lesion Count to Week 12 | Baseline, Week 12 | ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values. | percent change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12 | IDP-121 Lotion | -21.9 | Standard Deviation 22.70 | lesion count | |
| Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12 | IDP-121 Vehicle Lotion | -13.9 | Standard Deviation 23.30 | lesion count | |
| Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12 | IDP-121 Lotion | -13.9 | Standard Deviation 11.99 | lesion count | |
| Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12 | IDP-121 Vehicle Lotion | -10.7 | Standard Deviation 12.12 | lesion count | |
| Percentage of Participants With Treatment Success at Week 12 | IDP-121 Lotion | 19.8 | percentage of participants | ||
| Percentage of Participants With Treatment Success at Week 12 | IDP-121 Vehicle Lotion | 12.5 | percentage of participants | ||
| Percent Change From Baseline in Noninflammatory Lesion Count to Week 12 | IDP-121 Lotion | -45.6 | Standard Deviation 44.64 | percent change | |
| Percent Change From Baseline in Noninflammatory Lesion Count to Week 12 | IDP-121 Vehicle Lotion | -31.9 | Standard Deviation 45.79 | percent change | |
| Percent Change From Baseline in Inflammatory Lesion Count to Week 12 | IDP-121 Lotion | -53.4 | Standard Deviation 45.44 | percent change | |
| Percent Change From Baseline in Inflammatory Lesion Count to Week 12 | IDP-121 Vehicle Lotion | -41.5 | Standard Deviation 45.68 | percent change |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IDP-121 Lotion | 413 | |
| Overall Study | STARTED | IDP-121 Vehicle Lotion | 407 | |
| Overall Study | Intent-to-treat (ITT) Population | IDP-121 Lotion | 413 | |
| Overall Study | Intent-to-treat (ITT) Population | IDP-121 Vehicle Lotion | 407 | |
| Overall Study | Safety Population | IDP-121 Lotion | 389 | |
| Overall Study | Safety Population | IDP-121 Vehicle Lotion | 398 | |
| Overall Study | COMPLETED | IDP-121 Lotion | 342 | |
| Overall Study | COMPLETED | IDP-121 Vehicle Lotion | 364 | |
| Overall Study | NOT COMPLETED | IDP-121 Lotion | 71 | |
| Overall Study | NOT COMPLETED | IDP-121 Vehicle Lotion | 43 |
Source ClinicalTrials.gov
Adverse events6
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 |
|---|---|---|---|---|---|---|
| serious | Pregnancy | Pregnancy, puerperium and perinatal conditions | IDP-121 Lotion | 2 | 204 | |
| serious | Pregnancy | Pregnancy, puerperium and perinatal conditions | IDP-121 Vehicle Lotion | 1 | 229 | |
| serious | Pancreatitis | Gastrointestinal disorders | IDP-121 Lotion | 0 | 389 | |
| serious | Pancreatitis | Gastrointestinal disorders | IDP-121 Vehicle Lotion | 1 | 398 | |
| serious | Suicidal ideation | Psychiatric disorders | IDP-121 Lotion | 0 | 389 | |
| serious | Suicidal ideation | Psychiatric disorders | IDP-121 Vehicle Lotion | 1 | 398 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IDP-121 Lotion | 0 | 389 |
| Total, all-cause mortality | IDP-121 Vehicle Lotion | 0 | 398 |
| Total, other adverse events | IDP-121 Lotion | 0 | 389 |
| Total, other adverse events | IDP-121 Vehicle Lotion | 0 | 398 |
| Total, serious adverse events | IDP-121 Lotion | 2 | 389 |
| Total, serious adverse events | IDP-121 Vehicle Lotion | 2 | 398 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32886337 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IDP-121 Lotion vs IDP-121 Vehicle Lotion: deaths from any cause | Trial comparisons |
| IDP-121 Lotion vs IDP-121 Vehicle Lotion: serious adverse events | Trial comparisons |
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/NCT02965456
GET https://conductscience.org/api/trials/v1/NCT02965456/registered