Acne VulgarisPhase 2NCT04892706
Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel
A Phase 2 study testing IDP-126 Gel and Epiduo® Forte Gel in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 42 sites in 3 countries.
Trial summary
The safety and efficacy of once daily application of IDP 126 Gel will be compared to Epiduo® Forte and IDP-126 Vehicle Gel. Read more about this study
- Who is it for?
- Ages 12 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- IDP-126 Gel and Epiduo® Forte Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 686 participants
- Where
- 42 sitesin 3 countries
- Study dates
- 11 Jun 2021to 28 Sep 2022
- Phase
- Phase 2
- 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 12 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or female at least 12 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 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.
Show all 9Show fewer
- 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
42 sites in 3 countries.
42 sites in 3 countries
United States34 sites
Bausch Site 111
Austin, Texas, 78759
Bausch Site 127
Boise, Idaho, 83704
Bausch Site 105
Boynton Beach, Florida, 33437
Bausch Site 103
Brighton, Massachusetts, 21350
Bausch Site 134
Bryant, Arkansas, 72022
Bausch Site 126
Clearwater, Florida, 33761
Bausch Site 109
Dublin, Ohio, 43016
Bausch Site 110
Fremont, California, 94538
Bausch Site 107
Gresham, Oregon, 97030
Bausch Site 142
High Point, North Carolina, 27262
Bausch Site 132
Houston, Texas, 77098
Bausch Site 108
Las Vegas, Nevada, 89148
Bausch Site 129
Louisville, Kentucky, 40241
Bausch Site 139
Mandeville, Louisiana, 70448
Bausch Site 101
Manhattan Beach, California, 90266
Bausch Site 121
Metairie, Louisiana, 70006
Bausch Site 114
Nashville, Tennessee, 37215
Bausch Site 120
New Brighton, Minnesota, 55112
Bausch Site 119
New York, New York, 10022
Bausch Site 133
New York, New York, 10075
Bausch Site 124
Newnan, Georgia, 30263
Bausch Site 135
North Miami Beach, Florida, 33162
Bausch Site 117
Oklahoma City, Oklahoma, 73112
Bausch Site 123
Pflugerville, Texas, 78660
Bausch Site 116
Rockville, Maryland, 20850
Bausch Site 118
Rogers, Arkansas, 72758
Bausch Site 106
San Diego, California, 92123
Bausch Site 112
San Diego, California, 92123
Bausch Site 128
San Diego, California, 92123
Bausch Site 143
Sanford, Florida, 32771
Bausch Site 137
Spokane, Washington, 99202
Bausch Site 102
Tampa, Florida, 33607
Bausch Site 104
West Palm Beach, Florida, 33401
Bausch Site 122
West Palm Beach, Florida, 33406
Canada6 sites
Bausch Site 125
Markham, Ontario, L3P 1X3
Bausch Site 141
Oakville, Ontario, L6J 7W5
Bausch Site 115
Peterborough, Ontario, K91 5K2
Bausch Site 113
Saint-Jérôme, Quebec, J7Z 7E2
Bausch Site 130
Waterloo, Ontario, N2J 1C4
Bausch Site 138
Winnipeg, Manitoba, R3M 3Z4
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Clinical Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel (0.3% Adapalene/2.5% BPO), in the Treatment of Acne Vulgaris
The safety and efficacy of once daily application of IDP 126 Gel will be compared to Epiduo® Forte and IDP-126 Vehicle Gel.
Read the detailed description
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 with Epiduo® Forte gel and IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study, subjects must be at least 12 years of age and have a clinical diagnosis of moderate to severe acne (defined as an Evaluator's Global Severity Score [EGSS] of 3 or 4), presenting with 30-100 inflammatory facial lesions (papules, pustules, and nodules), 35-150 non-inflammatory facial lesions (open and closed comedones), and ≤ 2 facial nodules.
- Conditions
- Acne Vulgaris
- Being tested
- IDP-126 Gel, IDP-126 Vehicle Gel, Epiduo® Forte 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
Also called IDP-126
Gel applied to face once daily in the evening.
IDP-126 Vehicle GelDrug
Also called Vehicle
Gel applied to face once daily in the evening.
Epiduo® Forte GelDrug
Also called Epiduo® Forte
Gel applied to face once daily in the evening.
| Study group | Role | What they receive |
|---|---|---|
| IDP-126 Gel | Experimental | IDP-126 Gel (clindamycin phosphate 1.2%, BPO 3.1%, and adapalene 0.15%), applied topically to the face once daily for 12 weeks Receives: Drug: IDP-126 Gel |
| IDP-126 Vehicle Gel | Placebo comparator | IDP-126 Vehicle Gel applied once daily for 12 weeks Receives: Drug: IDP-126 Vehicle Gel |
| Epiduo® Forte Gel | Active comparator | Epiduo® Forte Gel (adapalene 0.3%/ 2.5% BPO) applied once daily for 12 weeks Receives: Drug: Epiduo® Forte 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 Lesion Counts.
Inflammatory and non-inflammatory lesion counts were collected starting from the Baseline Visit.
Measured: Baseline to Week 12
Percentage of Subjects Who Achieve at Least a Two-grade Reduction From Baseline and Are "Clear" or "Almost Clear" at Week 12 in the Evaluator's Global Severity Score.
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: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start11 Jun 2021
- Primary completion28 Sep 2022
- Study completion28 Sep 2022
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 (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 686 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Varsha Bhatt, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892706
- Sponsor's protocol ID
- V01-126A-202
- Status last verified
- Oct 2025
- First submitted
- 14 May 2021
- Last updated
- 30 Oct 2025
- 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 40377868
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Clinical Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel (0.3% Adapalene/2.5% BPO), in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT04892706
- Acronym / sponsor ID
- V01-126A-202
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 686 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Posted 30 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The safety and efficacy of once daily application of IDP 126 Gel will be compared to Epiduo® Forte and IDP-126 Vehicle Gel.
Detailed description
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 with Epiduo® Forte gel and IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study, subjects must be at least 12 years of age and have a clinical diagnosis of moderate to severe acne (defined as an Evaluator's Global Severity Score [EGSS] of 3 or 4), presenting with 30-100 inflammatory facial lesions (papules, pustules, and nodules), 35-150 non-inflammatory facial lesions (open and closed comedones), and ≤ 2 facial nodules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IDP-126 Gel | Experimental | Drug: IDP-126 GelIDP-126 Gel (clindamycin phosphate 1.2%, BPO 3.1%, and adapalene 0.15%), applied topically to the face once daily for 12 weeks |
| IDP-126 Vehicle Gel | Placebo comparator | Drug: IDP-126 Vehicle GelIDP-126 Vehicle Gel applied once daily for 12 weeks |
| Epiduo® Forte Gel | Active comparator | Drug: Epiduo® Forte GelEpiduo® Forte Gel (adapalene 0.3%/ 2.5% BPO) applied once daily for 12 weeks |
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female at least 12 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 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 GelAlso: IDP-126Gel applied to face once daily in the evening. | Drug | IDP-126 Gel |
| IDP-126 Vehicle GelAlso: VehicleGel applied to face once daily in the evening. | Drug | IDP-126 Vehicle Gel |
| Epiduo® Forte GelAlso: Epiduo® ForteGel applied to face once daily in the evening. | Drug | Epiduo® Forte Gel |
Primary outcome
Absolute Change From Baseline to Week 12 in Lesion Counts.
Time frame: Baseline to Week 12
Inflammatory and non-inflammatory lesion counts were collected starting from the Baseline Visit.
Percentage of Subjects Who Achieve at Least a Two-grade Reduction From Baseline and Are "Clear" or "Almost Clear" at Week 12 in the Evaluator's Global Severity Score.
Time frame: Baseline to 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- 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.
- 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.
Varsha Bhatt study director
Bausch Health Americas, Inc.
42 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IDP-126 Gel and Epiduo® Forte Gel in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 42 sites in 3 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 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Canada, Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 30 Oct 2025). 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 Lesion Counts. (time frame: Baseline to Week 12). The study lists 2 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 NCT04892706, which also lists 1 linked publication.
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 30 Oct 2025.