Acne VulgarisPhase 2NCT02525822
Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris
A Phase 2 study testing IDP-123 Lotion and Tazorac Cream, 0.1%, in people with Acne Vulgaris, run by Valeant Pharmaceuticals.
Trial summary
The primary objective of this study is to compare the safety and efficacy of once daily application of IDP-123 Lotion to Tazorac Cream, 0.1%, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- IDP-123 Lotion and Tazorac Cream, 0.1%,
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- 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
- Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment
- Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits
- Subjects must be willing to comply with study instructions and return to the clinic for required visits
Who cannot join
- Any dermatological conditions on the face that could interfere with clinical evaluations
- 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 who are unable to communicate or cooperate with the Investigator
- Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subjects safety while participating in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac® (Tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris
The primary objective of this study is to compare the safety and efficacy of once daily application of IDP-123 Lotion to Tazorac Cream, 0.1%, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne vulgaris.
Read the detailed description
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-123 Lotion in comparison with Tazorac Cream, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne. Treatment success will be evaluated by changes in inflammatory and non-inflammatory lesion counts, as well as treatment success using an Evaluator's Global Severity Score. IDP-123 is a lotion for the topical treatment of acne.
- Conditions
- Acne Vulgaris
- Being tested
- IDP-123 Lotion, Tazorac Cream, 0.1%,, Vehicle Cream, 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
Investigational Product: IDP-123 Lotion
Tazorac Cream, 0.1%,Drug
Also called tazarotene
Comparator Product: Tazorac Cream, 0.1%
Vehicle CreamDrug
Comparator Product: Vehicle Cream
Vehicle LotionDrug
Comparator Product: Vehicle Lotion
| Study group | Role | What they receive |
|---|---|---|
| IDP-123 Lotion | Experimental | IDP-123 Lotion, applied topically to the face, once daily for 12 weeks. Receives: Drug: IDP-123 Lotion |
| Tazorac Cream, 0.1% | Active comparator | Tazorac Cream (tazarotene 0.1%), applied topically to the face, once daily for 12 weeks. Receives: Drug: Tazorac Cream, 0.1%, |
| Vehicle Cream | Placebo comparator | Vehicle Cream, applied topically to the face, once daily for 12 weeks. Receives: Drug: Vehicle Cream |
| Vehicle Lotion | Placebo comparator | Vehicle Lotion, applied topically to the face, once daily for 12 weeks. Receives: Drug: Vehicle Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in mean inflammatory lesion counts at Week 12
Facial area lesion counts will be taken from the subject's face by the Evaluator at each visit and the change at week 12 from baseline will be calculated. Facial inflammatory lesions (pustules, papules, and nodules) will be counted as follows: pustules and papules will be counted and recorded together, not separately; nodular lesions will be counted and recorded separately.
Inflammatory lesions are defined as follows:
Papule - a solid, elevated lesion less than 5 mm; Pustule - an elevated lesion containing pus less than 5 mm; Nodule - palpable subcutaneous lesion greater than 5 mm; has depth, not necessarily elevated
Measured: 12 weeks
Absolute change in mean non-inflammatory lesion counts at Week 12
Facial area lesion counts will be taken from the subject's face by the Evaluator at each visit, and the change at week 12 from baseline will be calculated. Non-inflammatory lesions (open and closed comedones) will be counted and recorded together.
Non-inflammatory lesions are defined as follows:
Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface
Measured: 12 weeks
Percent 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
At each visit the severity will be determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations will be scored on a scale of 0-4 (Evaluator's Global Severity Score), with 0 being clear and 4 being severe. Please see below for complete definitions.
0 - Clear - Normal, clear skin with no evidence of acne vulgaris
- Almost clear- Rare non-inflammatory lesions present, with rare non-inflamed papules
- Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulocystic lesions)
- Moderate-Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one nodulocystic lesion
- Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulocystic lesions.
Measured: 12 weeks
Secondary outcomes (3)
Mean percent change in inflammatory lesion count from baseline at Weeks 2, 4, 8, and 12.
At each visit the Evaluator will count the total number of inflammatory lesions (papules, pustules, and nodules) on the subject's face, and the percent change will be calculated.
Measured: 2, 4, 8, and 12 weeks
Mean percent change in non-inflammatory lesion counts from baseline at Weeks 2, 4, 8 and 12.
At each visit the Evaluator will count the total number of non-inflammatory lesions (open and closed comedones), and the percent change will be calculated.
Measured: 2, 4, 8, and 12 weeks
The proportion of subjects with at least a two grade improvement in the Evaluator's Global Severity Score from baseline at Weeks 2, 4, 8 and 12.
At each visit the severity will be determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations will be scored on a scale of 0-4 (Evaluator's Global Severity Score), with 0 being clear and 4 being severe. Please see below for complete definitions.
0 - Clear - Normal, clear skin with no evidence of acne vulgaris
- Almost clear- Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red)
- Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulocystic lesions)
- Moderate-Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one nodulocystic lesion
- Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulocystic lesions.
Measured: 2, 4, 8, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valeant Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anya Loncaric, MS, Study director, Valeant Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525822
- Sponsor's protocol ID
- V01-123A-201
- Status last verified
- Sep 2015
- First submitted
- 13 Aug 2015
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac® (Tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02525822
- Acronym / sponsor ID
- V01-123A-201
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Valeant PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the safety and efficacy of once daily application of IDP-123 Lotion to Tazorac Cream, 0.1%, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne vulgaris.
Detailed description
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-123 Lotion in comparison with Tazorac Cream, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne. Treatment success will be evaluated by changes in inflammatory and non-inflammatory lesion counts, as well as treatment success using an Evaluator's Global Severity Score. IDP-123 is a lotion for the topical treatment of acne.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IDP-123 Lotion | Experimental | Drug: IDP-123 LotionIDP-123 Lotion, applied topically to the face, once daily for 12 weeks. |
| Tazorac Cream, 0.1% | Active comparator | Drug: Tazorac Cream, 0.1%,Tazorac Cream (tazarotene 0.1%), applied topically to the face, once daily for 12 weeks. |
| Vehicle Cream | Placebo comparator | Drug: Vehicle CreamVehicle Cream, applied topically to the face, once daily for 12 weeks. |
| Vehicle Lotion | Placebo comparator | Drug: Vehicle LotionVehicle Lotion, applied topically to the face, once daily for 12 weeks. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female at least 12 years of age and older
- Written and verbal informed consent must be obtained
- Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment
- Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits
- Subjects must be willing to comply with study instructions and return to the clinic for required visits
Key exclusion criteria (5 listed)
- Any dermatological conditions on the face that could interfere with clinical evaluations
- 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 who are unable to communicate or cooperate with the Investigator
- Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subjects safety while participating in 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-123 LotionInvestigational Product: IDP-123 Lotion | Drug | IDP-123 Lotion |
| Tazorac Cream, 0.1%,Also: tazaroteneComparator Product: Tazorac Cream, 0.1% | Drug | Tazorac Cream, 0.1% |
| Vehicle CreamComparator Product: Vehicle Cream | Drug | Vehicle Cream |
| Vehicle LotionComparator Product: Vehicle Lotion | Drug | Vehicle Lotion |
Primary outcome
Absolute change in mean inflammatory lesion counts at Week 12
Time frame: 12 weeks
Facial area lesion counts will be taken from the subject's face by the Evaluator at each visit and the change at week 12 from baseline will be calculated. Facial inflammatory lesions (pustules, papules, and nodules) will be counted as follows: pustules and papules will be counted and recorded together, not separately; nodular lesions will be counted and recorded separately. Inflammatory lesions are defined as follows: Papule - a solid, elevated lesion less than 5 mm; Pustule - an elevated lesion containing pus less than 5 mm; Nodule - palpable subcutaneous lesion greater than 5 mm; has depth, not necessarily elevated
Absolute change in mean non-inflammatory lesion counts at Week 12
Time frame: 12 weeks
Facial area lesion counts will be taken from the subject's face by the Evaluator at each visit, and the change at week 12 from baseline will be calculated. Non-inflammatory lesions (open and closed comedones) will be counted and recorded together. Non-inflammatory lesions are defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface
Percent 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: 12 weeks
At each visit the severity will be determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations will be scored on a scale of 0-4 (Evaluator's Global Severity Score), with 0 being clear and 4 being severe. Please see below for complete definitions. 0 - Clear - Normal, clear skin with no evidence of acne vulgaris 1. Almost clear- Rare non-inflammatory lesions present, with rare non-inflamed papules 2. Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulocystic lesions) 3. Moderate-Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one nodulocystic lesion 4. Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulocystic lesions.
3 secondary outcomes
Mean percent change in inflammatory lesion count from baseline at Weeks 2, 4, 8, and 12.
Time frame: 2, 4, 8, and 12 weeks
Mean percent change in non-inflammatory lesion counts from baseline at Weeks 2, 4, 8 and 12.
Time frame: 2, 4, 8, and 12 weeks
The proportion of subjects with at least a two grade improvement in the Evaluator's Global Severity Score from baseline at Weeks 2, 4, 8 and 12.
Time frame: 2, 4, 8, and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
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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, MS study director
Valeant Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IDP-123 Lotion and Tazorac Cream, 0.1%, in people with Acne Vulgaris, run by Valeant Pharmaceuticals.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anya Loncaric, MS (510-259-5284, aloncaric@solta.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in mean inflammatory lesion counts at Week 12 (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?
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 14 Sep 2015.