Acne VulgarisPhase 3NCT04214639
Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris
A Phase 3 study testing IDP-126 Gel in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 13 sites in 2 countries.
Trial summary
This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-126 Gel in comparison IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- IDP-126 Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 17 Jan 2020to 18 Jan 2021
- Phase
- Phase 3
- 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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 Evaluator's Global Severity Score (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 30, but no more than 100.
- Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 35, but no more than 150.
- Subjects with 2 or fewer facial nodules.
Who cannot join
- 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 more than 2 facial nodules.
- Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study.
- Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 12 weeks immediately preceding study entry; subjects treated with estrogens 12 or more consecutive weeks immediately prior to study entry need not be excluded unless the subject expects to change dose, drug or discontinue estrogen use during the study.
- Treatment of any type of cancer within the last 6 months, with the exception of complete surgical excision of skin cancer outside the treatment area.
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- Subjects who have not undergone specified washout period(s) for topical preparations/physical treatments used on the face or subjects who require the concurrent use in the treatment area.
- Subjects who have not undergone specified washout period(s) for systemic medications or subjects who require the concurrent use of systemic medications.
- Subjects with any underlying disease that the investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States11 sites
Bausch Site 102
Boynton Beach, Florida, 33463
Bausch Site 110
Bryant, Arkansas, 72022
Bausch Site 109
Denver, Colorado, 80220
Bausch Site 104
Fremont, California, 94538
Bausch Site 105
High Point, North Carolina, 27262
Bausch Site 103
Las Vegas, Nevada, 89148
Bausch Site 107
Nashville, Tennessee, 37215
Bausch Site 114
New York, New York, 10075
Bausch Site 111
North Miami Beach, Florida, 33162
Bausch Site 108
Pflugerville, Texas, 78660
Bausch Site 106
Sanford, Florida, 32771
Canada2 sites
Bausch Site 101
Barrie, Ontario, L4M 7G1
Bausch Site 113
Waterloo, Ontario, N2J 1C4
About this study
Official title: A Phase 3, 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
This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-126 Gel in comparison IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12.
- Conditions
- Acne Vulgaris
- Being tested
- IDP-126 Gel, IDP-126 Vehicle Gel
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDP-126 GelDrug
IDP-126 Gel applied topically to the face once daily for 12 weeks.
IDP-126 Vehicle GelDrug
IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| IDP-126 Gel | Experimental | Not described Receives: Drug: IDP-126 Gel |
| IDP-126 Vehicle Gel | Placebo comparator | Not described Receives: Drug: IDP-126 Vehicle Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline to Week 12 in Inflammatory Lesion Counts
Measured: 12 weeks
Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
Measured: 12 weeks
Percentage of Participants With Success on the Evaluator's Global Severity Score
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.
Measured: 12 weeks
Secondary outcomes (3)
Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12
Measured: Baseline to Week 4, 8, 12
Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12
Measured: Baseline to Week 4, 8, 12
Percentage of Participants With at Least a Two Grade Reduction on the Evaluator's Global Severity Score 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start17 Jan 2020
- Primary completion18 Jan 2021
- Study completion18 Jan 2021
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anya Loncaric, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214639
- Sponsor's protocol ID
- V01-126A-301
- Status last verified
- Jan 2024
- First submitted
- 30 Dec 2019
- Last updated
- 1 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gold M, Lain T, Harper JC, Baldwin H, Guenin E, Stein Gold L. Efficacy and Safety of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel: Post Hoc Analysis by Baseline Disease Severity. Dermatol Ther (Heidelb). 2025 Jul;15(7):1867-1882. doi: 10.1007/s13555-025-01440-z. Epub 2025 May 16.
PubMed 40377868Kircik LH, Stein Gold L, Gold M, Weiss JS, Harper JC, Del Rosso JQ, Bunick CG, Bhatia N, Tanghetti EA, Eichenfield LF, Baldwin H, Draelos ZD, Callender VD, Han G, Gooderham MJ, Sadick N, Lupo MP, Lain ET, Werschler WP. Triple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis. Dermatol Ther (Heidelb). 2024 May;14(5):1211-1227. doi: 10.1007/s13555-024-01155-7. Epub 2024 May 9.
PubMed 38724841
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, 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
- ClinicalTrials.gov ID
- NCT04214639
- Acronym / sponsor ID
- V01-126A-301
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Posted 1 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-126 Gel in comparison IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDP-126 Gel | Experimental | Drug: IDP-126 Gel |
| IDP-126 Vehicle Gel | Placebo comparator | Drug: IDP-126 Vehicle Gel |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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 Evaluator's Global Severity Score (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 30, but no more than 100.
- Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 35, but no more than 150.
Key exclusion criteria (9 listed)
- 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 more than 2 facial nodules.
- Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study.
- Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 12 weeks immediately preceding study entry; subjects treated with estrogens 12 or more consecutive weeks immediately prior to study entry need not be excluded unless the subject expects to change dose, drug or discontinue estrogen use during the study.
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 |
|---|---|---|
| IDP-126 GelIDP-126 Gel applied topically to the face once daily for 12 weeks. | Drug | IDP-126 Gel |
| IDP-126 Vehicle GelIDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks. | Drug | IDP-126 Vehicle Gel |
Primary outcome
Absolute Change From Baseline to Week 12 in Inflammatory Lesion Counts
Time frame: 12 weeks
Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
Time frame: 12 weeks
Percentage of Participants With Success on the Evaluator's Global Severity Score
Time frame: 12 weeks
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.
3 secondary outcomes
Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12
Time frame: Baseline to Week 4, 8, 12
Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12
Time frame: Baseline to Week 4, 8, 12
Percentage of Participants With at Least a Two Grade Reduction on the Evaluator's Global Severity Score at Week 12
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40377868Gold M, Lain T, Harper JC, Baldwin H, Guenin E, Stein Gold L. Efficacy and Safety of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel: Post Hoc Analysis by Baseline Disease Severity. Dermatol Ther (Heidelb). 2025 Jul;15(7):1867-1882. doi: 10.1007/s13555-025-01440-z. Epub 2025 May 16.
- Derived from this study: PubMed 38724841Kircik LH, Stein Gold L, Gold M, Weiss JS, Harper JC, Del Rosso JQ, Bunick CG, Bhatia N, Tanghetti EA, Eichenfield LF, Baldwin H, Draelos ZD, Callender VD, Han G, Gooderham MJ, Sadick N, Lupo MP, Lain ET, Werschler WP. Triple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis. Dermatol Ther (Heidelb). 2024 May;14(5):1211-1227. doi: 10.1007/s13555-024-01155-7. Epub 2024 May 9.
- Individual participant dataSharing planned: Undecided
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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.
Anya Loncaric study director
Bausch Health Americas, Inc.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IDP-126 Gel in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 13 sites in 2 countries.
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 6 inclusion and 9 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 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 1 Feb 2024). 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?
Absolute Change From Baseline to Week 12 in Inflammatory Lesion Counts (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 NCT04214639, which also lists 2 linked publications.
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 1 Feb 2024.