AcnePhase 3NCT02965456
Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
A Phase 3 study testing IDP 121 Lotion in people with Acne, run by Bausch Health Americas, Inc. at 34 sites in United States.
Trial summary
The objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an Evaluator's Global Severity Score [EGSS] of 3… Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Acne
- What is being tested?
- IDP 121 Lotion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 820 participants
- Where
- 34 sitesUnited States
- Study dates
- 4 Nov 2015to 23 Feb 2017
- 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. Participants 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 participant reaches age of consent during the study they should be re-consented at the next study visit).
- Participants must be willing to comply with study instructions and return to the study center for required visits. Participants under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.
- If a cleanser, moisturizer or sunscreen is needed during the study, participants must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the participant wears makeup they must agree to use non-comedogenic makeup.
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, gramnegative folliculitis.
- 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.
- Participants with a facial beard or mustache that could interfere with the study assessments.
- History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure, including known sensitivities to any dosage form of tretinoin.
- Participants who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.
- Participants with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the participant's safety while participating in the study.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Valeant Site 25
Anaheim, California, 92801
Valeant Site 10
Austin, Texas, 78759
Valeant Site 18
Beverly Hills, California, 90210
Valeant Site 16
Buffalo Grove, Illinois, 60089
Valeant Site 30
Clarkston, Michigan, 48346
Valeant Site 32
Crowley, Louisiana, 70526
Valeant Site 03
Detroit, Michigan, 48302
Valeant Site 09
Fremont, California, 94538
Valeant Site 21
Glendale, Arizona, 85308
Valeant Site 29
Hazleton, Pennsylvania, 18201
Valeant Site 20
Henderson, Nevada, 89074
Valeant Site 01
Houston, Texas, 77065
Valeant Site 06
Indianapolis, Indiana, 46256
Valeant Site 24
Johnston, Rhode Island, 02919
Valeant Site 28
Marietta, Georgia, 30060
Valeant Site 15
Miami, Florida, 33015
Valeant Site 11
Miami, Florida, 33144
Valeant Site 17
Murrieta, California, 92526
Valeant Site 08
New York, New York, 10016
Valeant Site 12
Overland Park, Kansas, 66215
Valeant Site 26
Oxnard, California, 93035
Valeant Site 27
Pinellas Park, Florida, 33782
Valeant Site 33
Port Arthur, Texas, 77460
Valeant Site 34
Rogers, Arkansas, 72758
Valeant Site 22
Sacramento, California, 95819
Valeant Site 07
San Antonio, Texas, 78229
Valeant Site 13
San Antonio, Texas, 78229
Valeant Site 14
San Antonio, Texas, 78249
Valeant Site 02
San Diego, California, 92123
Valeant Site 04
San Diego, California, 92123
Valeant Site 31
Sanford, Florida, 32771
Valeant Site 19
Santa Monica, California, 90404
Valeant Site 05
Tampa, Florida, 33624
Valeant Site 23
Winston-Salem, North Carolina, 27104
About this study
Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
The objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an Evaluator's Global Severity Score [EGSS] of 3 [moderate] or 4 [severe]).
- Conditions
- Acne
- Being tested
- IDP 121 Lotion, IDP-121 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 121 LotionDrug
IDP-121 lotion will be applied as per the instructions provided by the investigational center staff.
IDP-121 Vehicle LotionDrug
IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff.
| Study group | Role | What they receive |
|---|---|---|
| IDP-121 Lotion | Experimental | IDP-121 lotion (tretinoin 0.05 percent [%]) will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks. Receives: Drug: IDP 121 Lotion |
| IDP-121 Vehicle Lotion | Placebo comparator | IDP-121 lotion vehicle will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks. Receives: Drug: IDP-121 Vehicle Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12
Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
Measured: Baseline (Day 0), Week 12
Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12
Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.
Measured: Baseline, Week 12
Percentage of Participants With Treatment Success at Week 12
Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Measured: Baseline, Week 12
Secondary outcomes (2)
Percent Change From Baseline in Noninflammatory Lesion Count to Week 12
Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
Measured: Baseline, Week 12
Percent Change From Baseline in Inflammatory Lesion Count to Week 12
Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study start4 Nov 2015
- Primary completion23 Feb 2017
- Study completion23 Feb 2017
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 AcneStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Theisen, Study chair, TKL Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965456
- Sponsor's protocol ID
- V01-121A-302
- Status last verified
- Dec 2019
- First submitted
- 11 Oct 2016
- Last updated
- 18 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Tyring SK, Kircik L, Pariser DM, Woolery-Lloyd HC, Harper JC, Bhatt V, Pillai R, Guenin E. The Effects of Once-Daily Tretinoin 0.05% Lotion on Quality of Life in Patients with Moderate-to-Severe Acne Vulgaris. Am J Clin Dermatol. 2020 Dec;21(6):891-899. doi: 10.1007/s40257-020-00559-3.
PubMed 32886337
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. 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 Comparison Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02965456
- Acronym / sponsor ID
- V01-121A-302
- Conditions
- Acne
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 820 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2015 (actual)
- Primary completion
- 23 Feb 2017 (actual)
- Study completion
- 23 Feb 2017 (actual)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Posted 18 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an Evaluator's Global Severity Score [EGSS] of 3 [moderate] or 4 [severe]).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDP-121 Lotion | Experimental | Drug: IDP 121 LotionIDP-121 lotion (tretinoin 0.05 percent [%]) will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks. |
| IDP-121 Vehicle Lotion | Placebo comparator | Drug: IDP-121 Vehicle LotionIDP-121 lotion vehicle will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female at least 9 years of age and older.
- Written and verbal informed consent must be obtained. Participants 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 participant reaches age of consent during the study they should be re-consented at the next study visit).
- Participants must be willing to comply with study instructions and return to the study center for required visits. Participants under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.
- If a cleanser, moisturizer or sunscreen is needed during the study, participants must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the participant wears makeup they must agree to use non-comedogenic makeup.
Key exclusion criteria (7 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, gramnegative folliculitis.
- 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.
- Participants with a facial beard or mustache that could interfere with the study assessments.
- History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure, including known sensitivities to any dosage form of tretinoin.
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 121 LotionIDP-121 lotion will be applied as per the instructions provided by the investigational center staff. | Drug | IDP-121 Lotion |
| IDP-121 Vehicle LotionIDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff. | Drug | IDP-121 Vehicle Lotion |
Primary outcome
Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12
Time frame: Baseline (Day 0), Week 12
Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12
Time frame: Baseline, Week 12
Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.
Percentage of Participants With Treatment Success at Week 12
Time frame: Baseline, Week 12
Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
2 secondary outcomes
Percent Change From Baseline in Noninflammatory Lesion Count to Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in Inflammatory Lesion Count to Week 12
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32886337Tyring SK, Kircik L, Pariser DM, Woolery-Lloyd HC, Harper JC, Bhatt V, Pillai R, Guenin E. The Effects of Once-Daily Tretinoin 0.05% Lotion on Quality of Life in Patients with Moderate-to-Severe Acne Vulgaris. Am J Clin Dermatol. 2020 Dec;21(6):891-899. doi: 10.1007/s40257-020-00559-3.
- 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.
Tim Theisen study chair
TKL Research, Inc.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IDP 121 Lotion in people with Acne, run by Bausch Health Americas, Inc. at 34 sites in United States.
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 4 inclusion and 7 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 18 Dec 2019. 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. 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 18 Dec 2019). 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 in Mean Noninflammatory Lesion Count to Week 12 (time frame: Baseline (Day 0), 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 NCT02965456, 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 18 Dec 2019.