A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03170388 |
|
Recruitment Status :
Completed
First Posted : May 31, 2017
Results First Posted : November 10, 2021
Last Update Posted : November 10, 2021
|
Sponsor:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Bausch Health Americas, Inc.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acne Vulgaris | Drug: IDP-126 Gel Drug: IDP-126 Component A Drug: IDP-126 Component B Drug: IDP-126 Component C Drug: IDP-126 Vehicle Gel | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 741 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris |
| Actual Study Start Date : | October 5, 2017 |
| Actual Primary Completion Date : | April 23, 2019 |
| Actual Study Completion Date : | April 23, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: IDP-126 Gel
Gel
|
Drug: IDP-126 Gel
Gel |
|
Active Comparator: IDP-126 Component A
Component A
|
Drug: IDP-126 Component A
Component A |
|
Active Comparator: IDP-126 Component B
Component B
|
Drug: IDP-126 Component B
Component B |
|
Active Comparator: IDP-126 Component C
Component C
|
Drug: IDP-126 Component C
Component C |
|
Placebo Comparator: IDP-126 Vehicle Gel
Vehicle Gel
|
Drug: IDP-126 Vehicle Gel
Vehicle Gel |
Primary Outcome Measures :
- Inflammatory Lesion Counts [ Time Frame: Baseline to Week 12 ]Absolute change from Baseline to Week 12 in mean inflammatory lesion counts
- Non-inflammatory Lesion Counts [ Time Frame: Baseline to Week 12 ]Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts
- Percentage of Participants With Success on the Evaluator's Global Severity Score [ Time Frame: Baseline to Week 12 ]Success was defined as at least a two grade reduction and clear or almost clear at Week 12. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
Secondary Outcome Measures :
- Inflammatory Lesion Count Changes at Week 2, 4, and 8 [ Time Frame: Baseline to Week 2, 4, 8 ]Absolute change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
- Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 [ Time Frame: Baseline to Week 2, 4, 8 ]Absolute change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
- Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 [ Time Frame: Baseline to Week 2, 4, 8 ]Percentage change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
- Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 [ Time Frame: Baseline to Week 2, 4, 8 ]Percentage change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
- Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 [ Time Frame: Baseline to Week 2, 4, and 8 ]Success was defined as at least a two grade reduction and clear or almost clear at the visit. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
- Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 [ Time Frame: Baseline to Week 2, 4, and 8 ]Two grade success was defined as at least a two grade reduction. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 9 Years to 99 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female at least 9 years of age and older.
- Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit).
- Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit.
- Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20, but no more than 100.
- Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than 150.
- Subjects with 2 or fewer facial nodules
Exclusion Criteria:
- Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
- Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram negative folliculitis, dermatitis, eczema.
- Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
- Subjects with a facial beard or mustache that could interfere with the study assessments.
- Subjects with more than 2 facial nodules.
- Evidence or history of cosmetic-related acne.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170388
Locations
Show 34 study locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
| Study Director: | Anya Loncaric | Bausch Health Americas, Inc. |
Study Documents (Full-Text)
Documents provided by Bausch Health Americas, Inc.:
Documents provided by Bausch Health Americas, Inc.:
Study Protocol and Statistical Analysis Plan [PDF] August 22, 2017
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bausch Health Americas, Inc. |
| ClinicalTrials.gov Identifier: | NCT03170388 |
| Other Study ID Numbers: |
V01-126A-201 |
| First Posted: | May 31, 2017 Key Record Dates |
| Results First Posted: | November 10, 2021 |
| Last Update Posted: | November 10, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases |