Acne VulgarisPhase 3NCT03168321

A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)

A Phase 3 study testing IDP-123 Lotion in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 45 sites in 2 countries.

Completed

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

Official record

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Trial summary

This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle Lotion. 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-123 Lotion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 813 participants
Where: 45 sitesin 2 countries
Study dates: 29 Jun 2017to 7 Jun 2018
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 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 a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the baseline visit;
Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;
Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;
Subjects with two or fewer 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 two (2) facial nodules;
Evidence or history of cosmetic-related acne

Trial locations and contacts

45 sites in 2 countries.

Country

City, postcode or hospital

45 sites in 2 countries

United States42 sites

Valeant Site 06
Arlington Heights, Illinois, 60005
Valeant Site 12
Austin, Texas, 78759
Valeant Site 35
Boca Raton, Florida, 33486
Valeant Site 30
Boise, Idaho, 83704
Valeant Site 32
Cincinnati, Ohio, 45236
Valeant Site 38
Detroit, Michigan, 48202
Valeant Site 11
Dublin, Ohio, 43016
valeant Site 07
Gresham, Oregon, 97030
Valeant Site 09
High Point, North Carolina, 27262
Valeant Site 24
Hot Springs, Arkansas, 71913
Valeant Site 15
Johnston, Rhode Island, 02919
Valeant Site 05
Katy, Texas, 77494
Valeant Site 34
Knoxville, Tennessee, 37917
Valeant Site 04
La Mesa, California, 91942
Valeant Site 22
Louisville, Kentucky, 40217
Valeant Site 02
Manhattan Beach, California, 90266
Valeant Site 08
Metairie, Louisiana, 70006
Valeant Site 42
Murrieta, California, 92562
valeant Site 14
Nashville, Tennessee, 37215
Valeant Site 23
New Albany, Indiana, 47150
Valeant site 20
New York, New York, 10022
Valeant Site 36
New York, New York, 10075
Valeant Site 26
Newnan, Georgia, 30263
Valeant Site 45
Norfolk, Virginia, 23507
Valeant Site 40
North Miami Beach, Florida, 33162
Valeant Site 33
Ormond Beach, Florida, 32174
Valeant Site 31
Overland Park, Kansas, 66215
Valeant Site 27
Pembroke Pines, Florida, 33028
Valeant Site 19
Phoenix, Arizona, 85032
Valeant Site 21
Phoenix, Arizona, 85032
Valeant Site 18
Plano, Texas, 75093
Valeant Site 39
Sacramento, California, 95819
Valeant Site 41
Salt Lake City, Utah, 84114
Valeant Site 25
San Antonio, Texas, 78213
Valeant Site 01
San Diego, California, 22434
Valeant Site 13
Sanford, Florida, 32771
Valeant Site 17
South Bend, Indiana, 46617
Valeant Site 44
Spokane, Washington, 99202
Valeant Site 16
Warren, Michigan, 48088
Valeant Site 43
Webster, Texas, 77598
Valeant Site 03
West Palm Beach, Florida, 33401
Valeant Site 37
Wheat Ridge, Colorado, 80033

Other trials in United States

Canada3 sites

Valeant Site 10
Laval, Quebec, H7E0E3
Valeant Site 29
Peterborough, Ontario, K9J5K2
Valeant Site 28
Waterloo, Ontario, N2J1C4

Other trials in Canada

About this study

Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-123 Lotion and IDP-123 Vehicle Lotion in the Treatment of Acne Vulgaris

Read the detailed description

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123 Vehicle Lotion. To be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne.

Conditions: Acne Vulgaris
Being tested: IDP-123 Lotion, IDP-123 Vehicle Lotion
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-123 LotionDrug
Also called IDP-123
Tazarotene 0.045% Lotion
IDP-123 Vehicle LotionDrug
Also called Vehicle
Vehicle Lotion

Study groups in NCT03168321
Study group	Role	What they receive
IDP-123 Lotion	Experimental	Tazarotene 0.045% Lotion Receives: Drug: IDP-123 Lotion
IDP-123 Vehicle Lotion	Placebo comparator	Vehicle Lotion Receives: Drug: IDP-123 Vehicle Lotion

What is being measured

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

Absolute Change in Mean Lesion Counts at Week 12
For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Measured: Baseline to Week 12
Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear"
Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.
Measured: Baseline to Week 12

Secondary outcomes (4)

Percentage Change in Mean Lesion Counts at Week 12
For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Measured: Baseline to Week 12
Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)
Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.
Measured: Baseline to Week 12
Percentage Change in Mean Lesion Counts at Week 8
For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Measured: Baseline to Week 8
Percentage Change in Mean Lesion Counts at Week 4
For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Measured: Baseline to Week 4

Timeline

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

29 Jun 20177 Jun 2018

First posted30 May 2017
Study start29 Jun 2017
Primary completion7 Jun 2018
Study completion7 Jun 2018

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.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
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, Care provider, Investigator
Enrolment: 813 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03168321
Sponsor's protocol ID: V01-123A-301
Status last verified: Mar 2021
First submitted: 24 May 2017
Last updated: 1 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

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

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)
Acne Vulgaris
Enrolling by invitationPhase 2/3
A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
Acne
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
Acne Vulgaris, Acne Vulgaris on the Face

All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-123 Lotion and IDP-123 Vehicle Lotion in the Treatment of Acne Vulgaris
ClinicalTrials.gov ID: NCT03168321
Acronym / sponsor ID: V01-123A-301
Conditions: Acne Vulgaris
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 813 participants (actual)
Lead sponsor: Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
Study start: 29 Jun 2017 (actual)
Primary completion: 7 Jun 2018 (actual)
Study completion: 7 Jun 2018 (actual)
First posted: 30 May 2017 (actual)
Results: Posted 1 Apr 2021

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
IDP-123 Lotion	Experimental	Drug: IDP-123 LotionTazarotene 0.045% Lotion
IDP-123 Vehicle Lotion	Placebo comparator	Drug: IDP-123 Vehicle LotionVehicle Lotion

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 a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the baseline visit;
Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;
Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;

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 two (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-123 LotionAlso: IDP-123Tazarotene 0.045% Lotion	Drug	IDP-123 Lotion
IDP-123 Vehicle LotionAlso: VehicleVehicle Lotion	Drug	IDP-123 Vehicle Lotion

Primary outcome

Absolute Change in Mean Lesion Counts at Week 12
Time frame: Baseline to Week 12
For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear"
Time frame: Baseline to Week 12
Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.

4 secondary outcomes

Percentage Change in Mean Lesion Counts at Week 12
Time frame: Baseline to Week 12
Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)
Time frame: Baseline to Week 12
Percentage Change in Mean Lesion Counts at Week 8
Time frame: Baseline to Week 8
Percentage Change in Mean Lesion Counts at Week 4
Time frame: Baseline to Week 4

Results and safety

Results posted to the registry on 1 Apr 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-123 Lotion	402	347
Vehicle Lotion	411	356

Primary outcome: Absolute Change in Mean Lesion Counts at Week 12

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

Measure	IDP-123 Lotion n = 402	Vehicle Lotion n = 411
Non-inflammatory lesions	-21.0 (14.72)	-16.4 (14.52)
Inflammatory lesions	-15.6 (10.41)	-12.4 (10.43)

Primary outcome: Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear"

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

Measure	IDP-123 Lotion n = 402	Vehicle Lotion n = 411
Value	25.5	13.0

4 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-123 Lotion	3 of 392 (0.8%)	0 of 392 (0%)	0 of 392
Vehicle Lotion	3 of 399 (0.8%)	0 of 399 (0%)	0 of 399

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Acne Vulgaris

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)
Acne Vulgaris
Enrolling by invitationPhase 2/3
A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
Acne
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
Acne Vulgaris, Acne Vulgaris on the Face

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

Valeant Pharmaceuticals

45 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-123 Lotion in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 45 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 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 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 Apr 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?

Absolute Change in Mean Lesion Counts at Week 12 (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 NCT03168321.

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 Apr 2021; AzTrials last refreshed its copy on 1 Nov 2026.