Acne VulgarisPhase 2NCT03170388

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

A Phase 2 study testing IDP-126 Gel, IDP-126 Component A and IDP-126 Component B in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 34 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris Read more about this study

Who is it for?: Ages 9 to 99 years
Conditions the study is for: Acne Vulgaris
What is being tested?: IDP-126 Gel, IDP-126 Component A and IDP-126 Component B
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 741 participants
Where: 34 sitesin 2 countries
Study dates: 5 Oct 2017to 23 Apr 2019
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 9 to 99 years
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 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

Who cannot join

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.

Trial locations and contacts

34 sites in 2 countries.

Country

City, postcode or hospital

34 sites in 2 countries

United States29 sites

Valeant Site 25
Albuquerque, New Mexico, 87106
Valeant Site 32
Austin, Texas, 78759
Valeant Site 16
Boise, Idaho, 83704
Valeant Site 11
Boynton Beach, Florida, 33437
Valeant Site 09
Denver, Colorado, 80220
Valeant Site 22
Detroit, Michigan, 48202
Valeant Site 07
Fremont, California, 94538
valeant Site 21
Glenn Dale, Maryland, 20769
Valeant Site 28
Gresham, Oregon, 97030
Valeant Site 23
High Point, North Carolina, 27262
Valeant Site 02
Hot Springs, Arkansas, 71913
Valeant Site 30
Johnston, Rhode Island, 02919
Valeant Site 18
Louisville, Kentucky, 40217
Valeant Site 19
Louisville, Kentucky, 40241
Valeant Site 15
Marietta, Georgia, 30060
Valeant Site 24
Morristown, New Jersey, 07960
Valeant Site 31
Nashville, Tennessee, 37215
Valeant Site 20
Needham, Massachusetts, 02492
Valeant Site 27
New York, New York, 10022
Valeant Site 26
New York, New York, 10075
Valeant Site 35
Norfolk, Virginia, 23502
Valeant Site 13
North Miami Beach, Florida, 33162
Valeant Site 17
Overland Park, Kansas, 66215
Valeant Site 33
Pflugerville, Texas, 78660
Valeant Site 08
Sacramento, California, 95819
valeant Site 34
San Antonio, Texas, 78213
Valeant Site 12
Sanford, Florida, 32771
Valeant Site 14
Snellville, Georgia, 30078
Valeant Site 10
West Palm Beach, Florida, 33401

Other trials in United States

Canada5 sites

Valeant Site 05
Barrie, Ontario, L4M7G1
Valeant Site 06
Oakville, Ontario, L6J7W5
Valeant Site 04
Peterborough, Ontario, K9J5K2
Valeant Site 03
Waterloo, Ontario, N2J1C4
Valeant Site 01
Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

About this study

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

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

Read the detailed description

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

Conditions: Acne Vulgaris
Being tested: IDP-126 Gel, IDP-126 Component A, IDP-126 Component B, IDP-126 Component C, 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
Gel
IDP-126 Component ADrug
Component A
IDP-126 Component BDrug
Component B
IDP-126 Component CDrug
Component C
IDP-126 Vehicle GelDrug
Vehicle Gel

Study groups in NCT03170388
Study group	Role	What they receive
IDP-126 Gel	Experimental	Gel Receives: Drug: IDP-126 Gel
IDP-126 Component A	Active comparator	Component A Receives: Drug: IDP-126 Component A
IDP-126 Component B	Active comparator	Component B Receives: Drug: IDP-126 Component B
IDP-126 Component C	Active comparator	Component C Receives: Drug: IDP-126 Component C
IDP-126 Vehicle Gel	Placebo comparator	Vehicle Gel Receives: Drug: IDP-126 Vehicle Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

Inflammatory Lesion Counts
Absolute change from Baseline to Week 12 in mean inflammatory lesion counts
Measured: Baseline to Week 12
Non-inflammatory Lesion Counts
Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts
Measured: Baseline to Week 12
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: Baseline to Week 12

Secondary outcomes (6)

Inflammatory Lesion Count Changes at Week 2, 4, and 8
Absolute change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
Measured: Baseline to Week 2, 4, 8
Non-inflammatory Lesion Count Changes at Week 2, 4, and 8
Absolute change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
Measured: Baseline to Week 2, 4, 8
Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Percentage change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
Measured: Baseline to Week 2, 4, 8
Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Percentage change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
Measured: Baseline to Week 2, 4, 8
Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 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.
Measured: Baseline to Week 2, 4, and 8
Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 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.
Measured: Baseline to Week 2, 4, and 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 201723 Apr 2019

First posted31 May 2017
Study start5 Oct 2017
Primary completion23 Apr 2019
Study completion23 Apr 2019

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 741 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03170388
Sponsor's protocol ID: V01-126A-201
Status last verified: Oct 2021
First submitted: 26 May 2017
Last updated: 10 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

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
Stein Gold L, Baldwin H, Kircik LH, Weiss JS, Pariser DM, Callender V, Lain E, Gold M, Beer K, Draelos Z, Sadick N, Pillai R, Bhatt V, Tanghetti EA. Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: A Randomized Phase II Study of the First Triple-Combination Drug. Am J Clin Dermatol. 2022 Jan;23(1):93-104. doi: 10.1007/s40257-021-00650-3. Epub 2021 Oct 21.
PubMed 34674160

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03170388
Acronym / sponsor ID: V01-126A-201
Conditions: Acne Vulgaris
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 741 participants (actual)
Lead sponsor: Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
Study start: 5 Oct 2017 (actual)
Primary completion: 23 Apr 2019 (actual)
Study completion: 23 Apr 2019 (actual)
First posted: 31 May 2017 (actual)
Results: Posted 10 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5
Model description: Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group

Arm	Type	Receives
IDP-126 Gel	Experimental	Drug: IDP-126 GelGel
IDP-126 Component A	Active comparator	Drug: IDP-126 Component AComponent A
IDP-126 Component B	Active comparator	Drug: IDP-126 Component BComponent B
IDP-126 Component C	Active comparator	Drug: IDP-126 Component CComponent C
IDP-126 Vehicle Gel	Placebo comparator	Drug: IDP-126 Vehicle GelVehicle Gel

Who may qualify

Ages: 9 to 99 years
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 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.

Key exclusion criteria (6 listed)

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.

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 GelGel	Drug	IDP-126 Gel
IDP-126 Component AComponent A	Drug	IDP-126 Component A
IDP-126 Component BComponent B	Drug	IDP-126 Component B
IDP-126 Component CComponent C	Drug	IDP-126 Component C
IDP-126 Vehicle GelVehicle Gel	Drug	IDP-126 Vehicle Gel

Primary outcome

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.

6 secondary outcomes

Inflammatory Lesion Count Changes at Week 2, 4, and 8
Time frame: Baseline to Week 2, 4, 8
Non-inflammatory Lesion Count Changes at Week 2, 4, and 8
Time frame: Baseline to Week 2, 4, 8
Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Time frame: Baseline to Week 2, 4, 8
Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Time frame: Baseline to Week 2, 4, 8
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
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

Results and safety

Results posted to the registry on 10 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IDP-126 Gel	147	125
IDP-126 Component A	150	132
IDP-126 Component B	146	133
IDP-126 Component C	150	132
IDP-126 Vehicle Gel	148	127

Primary outcome: Inflammatory Lesion Counts

Time frame: Baseline to Week 12. Least squares mean (Standard Deviation). Unit: lesions

Measure	IDP-126 Gel n = 146	IDP-126 Component A n = 150	IDP-126 Component B n = 146	IDP-126 Component C n = 150	IDP-126 Vehicle Gel n = 148
Value	-29.9 (11.86)	-26.7 (11.74)	-24.8 (11.71)	-26.8 (11.69)	-19.6 (12.12)

Population analysed: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.

Primary outcome: Non-inflammatory Lesion Counts

Time frame: Baseline to Week 12. Least squares mean (Standard Deviation). Unit: lesions

Measure	IDP-126 Gel n = 146	IDP-126 Component A n = 150	IDP-126 Component B n = 146	IDP-126 Component C n = 150	IDP-126 Vehicle Gel n = 148
Value	-35.5 (16.25)	-29.9 (16.40)	-27.8 (15.97)	-30.0 (16.40)	-21.8 (16.58)

Population analysed: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.

Primary outcome: Percentage of Participants With Success on the Evaluator's Global Severity Score

Time frame: Baseline to Week 12. Number. Unit: percentage of participants

Measure	IDP-126 Gel n = 146	IDP-126 Component A n = 150	IDP-126 Component B n = 146	IDP-126 Component C n = 150	IDP-126 Vehicle Gel n = 148
Value	52.5	27.8	30.5	30.3	8.1

Population analysed: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IDP-126 Gel	1 of 141 (0.7%)	30 of 141 (21.3%)	0 of 141
IDP-126 Component A	0 of 146 (0%)	29 of 146 (19.9%)	0 of 146
IDP-126 Component B	0 of 144 (0%)	6 of 144 (4.2%)	0 of 144
IDP-126 Component C	3 of 148 (2%)	19 of 148 (12.8%)	0 of 148
IDP-126 Vehicle Gel	0 of 146 (0%)	7 of 146 (4.8%)	0 of 146

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
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 34674160Stein Gold L, Baldwin H, Kircik LH, Weiss JS, Pariser DM, Callender V, Lain E, Gold M, Beer K, Draelos Z, Sadick N, Pillai R, Bhatt V, Tanghetti EA. Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: A Randomized Phase II Study of the First Triple-Combination Drug. Am J Clin Dermatol. 2022 Jan;23(1):93-104. doi: 10.1007/s40257-021-00650-3. Epub 2021 Oct 21.
Individual participant dataSharing planned: Yes

Related trials for Acne Vulgaris

Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Not yet recruiting
Evaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
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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.

34 sites in 2 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, IDP-126 Component A and IDP-126 Component B in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 34 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 6 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 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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 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 10 Nov 2021). 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?

Inflammatory Lesion Counts (time frame: Baseline to Week 12). 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 NCT03170388, 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 10 Nov 2021.