Acne VulgarisPhase 2NCT01616654

Dose Range Study of CD5789 in Acne Vulgaris

A Phase 2 study testing CD5789 25 µg/g cream, CD5789 50 µg/g cream and CD5789 100 µg/g cream in people with Acne Vulgaris, run by Galderma R&D at 24 sites in United States.

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

To assess the efficacy and safety of different concentrations of CD5789 cream in participants with acne vulgaris for the purpose of dose identification. Read more about this study

Who is it for?: Ages 12 to 35 years
Conditions the study is for: Acne Vulgaris
What is being tested?: CD5789 25 µg/g cream, CD5789 50 µg/g cream and CD5789 100 µg/g cream
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 304 participants
Where: 24 sitesUnited States
Study dates: 20 Jun 2012to 12 Jun 2014
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 35 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Male or female participant, 12 to 35 years old with the following characteristics:
Facial acne severity grade of the following:
Stratum 1: IGA score of 3 or 4
Stratum 2: IGA score of 4
Stratum 3: IGA score of 3 or 4
A minimum of 30 non-inflammatory lesions and fulfills the criteria of one of the following strata:

Show all 10Show fewer

Stratum 1: A minimum of 20 but not more than 40 inflammatory lesions, and a maximum of one nodule on the face.
Stratum 2: More than 40 inflammatory lesions, and up to four nodules on the face.
Stratum 3: Participants of Japanese origin with at least 20 inflammatory lesions and up to four nodules on the face.
Note: Participants of Japanese origin will not be included in Stratum 1 or Stratum 2. Japanese origin is defined as all four grandparents were born in Japan.

Who cannot join

The presence of severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.)
Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the participant at significant risk (according to the Investigator's judgment) if the participant participates in the clinical trial.
Known or suspected allergies or sensitivities to any components of any of the study drugs.
Current participation in any other clinical trial of a drug or device OR past participation within the 30 days prior to the Baseline visit.

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Arlington Center for Dermatology
Arlington, Texas, 76011
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35205
Deaconess Clinic, Inc.
Evansville, Indiana, 47713
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Parexel Early Phase
Glendale, California, 91206
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, 29607
Zoe Drealos, MD
High Point, North Carolina, 27262
Suzanne Bruce and Associates P.A. The Center for Skin Research
Houston, Texas, 77056
Dermatology Specialists PC
Louisville, Kentucky, 40202
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501
Odyssey Medispa
Marina del Rey, California, 90292
FXM Research Corp Miami
Miami, Florida, 33175
FMX Research Miramar
Miramar, Florida, 33027
Meda Phase, Inc
Newnan, Georgia, 30263
Central Sooner Research
Norman, Oklahoma, 73069
Skin Specialists, PC
Omaha, Nebraska, 68144
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Dermatology Research Center
Salt Lake City, Utah, 84124
Stephen Miller MD
San Antonio, Texas, 78229
Rady Children's Hospital
San Diego, California, 92123
Somerset Skin Centre
Troy, Michigan, 48084
Center for Clinical Studies
Webster, Texas, 77598
PMG Research of Wilmington
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Randomized, Multi-center, Investigator-blind, Vehicle- and Active-controlled, Phase 2 Study to Assess the Efficacy and Safety of Different Concentrations of CD5789 Cream Applied Once Daily in Subjects With Moderate to Severe Acne Vulgaris

To assess the efficacy and safety of different concentrations of CD5789 cream in participants with acne vulgaris for the purpose of dose identification.

Conditions: Acne Vulgaris
Being tested: CD5789 25 µg/g cream, CD5789 50 µg/g cream, CD5789 100 µg/g cream, Tazarotene 0.1% gel, Vehicle cream
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CD5789 25 µg/g creamDrug
CD5789 25 µg/g cream applied once daily
CD5789 50 µg/g creamDrug
CD5789 50 µg/g cream applied once daily
CD5789 100 µg/g creamDrug
CD5789 100 µg/g cream applied once daily
Tazarotene 0.1% gelDrug
Tazarotene 0.1% gel applied once daily
Vehicle creamDrug
Vehicle cream applied once daily

Study groups in NCT01616654
Study group	Role	What they receive
CD5789 25 mcg/g Cream	Experimental	Participants randomized in stratum 1, 2 and 3 were applied with 25 mcg/g CD5789 cream, once daily for 12 weeks. Receives: Drug: CD5789 25 µg/g cream
CD5789 50 mcg/g Cream	Experimental	Participants randomized in stratum 1, 2 and 3 were applied with 50 mcg/g CD5789 50 once daily for 12 weeks. Receives: Drug: CD5789 50 µg/g cream
CD5789 100 mcg/g Cream	Active comparator	Participants randomized in stratum 1, 2 and 3 were applied with 100 mcg/g CD5789 cream, once daily for 12 weeks. Receives: Drug: CD5789 100 µg/g cream
Tazarotene 0.1% Gel	Placebo comparator	Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks. Receives: Drug: Tazarotene 0.1% gel
Vehicle Cream	Experimental	Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks. Receives: Drug: Vehicle cream

What is being measured

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

Percentage of Participants With Success Rate 1 (SR1)
Success Rate 1 was defined as percentage of participants who achieved at least a two-point reduction in the Investigator Global Assessment (IGA) scale from baseline at week 12. Evaluation of acne was performed by the investigator based on the following 5 point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).
Measured: From Baseline at Week 12
Absolute Change From Baseline in Total Lesion Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)
The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.
Measured: Baseline, Week 12
Percentage Change From Baseline in Total Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)
The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.
Measured: Baseline, Week 12

Secondary outcomes (3)

Percentage of Participants With Success Rate 2 (SR2)
Success Rate 2 (SR2) was defined as the percentage of participants rated "Clear" (Grade 0) or "Almost clear" (Grade 1) with at least a two-point reduction on the IGA scale from Baseline to Week 12. Evaluation of acne was performed by the investigator based on the following 5 point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, higher score indicated higher severity. All missing values were imputed by LOCF.
Measured: From Baseline to Week 12
Absolute Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 1 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). All missing values were imputed by LOCF.
Measured: Baseline, Week 12
Percentage Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 1 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). All missing values were imputed by LOCF. Percent changes in lesion counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100.
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.

20 Jun 201212 Jun 2014

First posted12 Jun 2012 (estimated)
Study start20 Jun 2012
Primary completion24 Jul 2013
Study completion12 Jun 2014

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.
More trials run by Galderma R&DThe 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 304 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01616654
Sponsor's protocol ID: RD.06.SPR.18223
Status last verified: Aug 2021
First submitted: 8 Jun 2012
Last updated: 20 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
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RecruitingPhase 4
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RecruitingPhase 4
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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multi-center, Investigator-blind, Vehicle- and Active-controlled, Phase 2 Study to Assess the Efficacy and Safety of Different Concentrations of CD5789 Cream Applied Once Daily in Subjects With Moderate to Severe Acne Vulgaris
ClinicalTrials.gov ID: NCT01616654
Acronym / sponsor ID: RD.06.SPR.18223
Conditions: Acne Vulgaris
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 304 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 20 Jun 2012 (actual)
Primary completion: 24 Jul 2013 (actual)
Study completion: 12 Jun 2014 (actual)
First posted: 12 Jun 2012 (estimated)
Results: Posted 20 Sep 2021

Clinical summary

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

To assess the efficacy and safety of different concentrations of CD5789 cream in participants with acne vulgaris for the purpose of dose identification.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
CD5789 25 mcg/g Cream	Experimental	Drug: CD5789 25 µg/g creamParticipants randomized in stratum 1, 2 and 3 were applied with 25 mcg/g CD5789 cream, once daily for 12 weeks.
CD5789 50 mcg/g Cream	Experimental	Drug: CD5789 50 µg/g creamParticipants randomized in stratum 1, 2 and 3 were applied with 50 mcg/g CD5789 50 once daily for 12 weeks.
CD5789 100 mcg/g Cream	Active comparator	Drug: CD5789 100 µg/g creamParticipants randomized in stratum 1, 2 and 3 were applied with 100 mcg/g CD5789 cream, once daily for 12 weeks.
Tazarotene 0.1% Gel	Placebo comparator	Drug: Tazarotene 0.1% gelParticipants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
Vehicle Cream	Experimental	Drug: Vehicle creamParticipants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.

Who may qualify

Ages: 12 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (10 listed)

Male or female participant, 12 to 35 years old with the following characteristics:
Facial acne severity grade of the following:
A minimum of 30 non-inflammatory lesions and fulfills the criteria of one of the following strata:

Key exclusion criteria (4 listed)

The presence of severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.)
Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the participant at significant risk (according to the Investigator's judgment) if the participant participates in the clinical trial.
Known or suspected allergies or sensitivities to any components of any of the study drugs.
Current participation in any other clinical trial of a drug or device OR past participation within the 30 days prior to the Baseline visit.

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
CD5789 25 µg/g creamCD5789 25 µg/g cream applied once daily	Drug	CD5789 25 mcg/g Cream
CD5789 50 µg/g creamCD5789 50 µg/g cream applied once daily	Drug	CD5789 50 mcg/g Cream
CD5789 100 µg/g creamCD5789 100 µg/g cream applied once daily	Drug	CD5789 100 mcg/g Cream
Tazarotene 0.1% gelTazarotene 0.1% gel applied once daily	Drug	Tazarotene 0.1% Gel
Vehicle creamVehicle cream applied once daily	Drug	Vehicle Cream

Primary outcome

Percentage of Participants With Success Rate 1 (SR1)
Time frame: From Baseline at Week 12
Success Rate 1 was defined as percentage of participants who achieved at least a two-point reduction in the Investigator Global Assessment (IGA) scale from baseline at week 12. Evaluation of acne was performed by the investigator based on the following 5 point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).
Absolute Change From Baseline in Total Lesion Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)
Time frame: Baseline, Week 12
The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.
Percentage Change From Baseline in Total Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)
Time frame: Baseline, Week 12
The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.

3 secondary outcomes

Percentage of Participants With Success Rate 2 (SR2)
Time frame: From Baseline to Week 12
Absolute Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
Time frame: Baseline, Week 12
Percentage Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
Time frame: Baseline, Week 12

Results and safety

Results posted to the registry on 20 Sep 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
CD5789 25 mcg/g Cream	61	56
CD5789 50 mcg/g Cream	61	53
CD5789 100 mcg/g Cream	60	50
Tazarotene 0.1% Gel	61	53
Vehicle Cream	61	49

Primary outcome: Percentage of Participants With Success Rate 1 (SR1)

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

Measure	CD5789 25 mcg/g Cream n = 61	CD5789 50 mcg/g Cream n = 61	CD5789 100 mcg/g Cream n = 60	Tazarotene 0.1% Gel n = 61	CD5789 Vehicle Cream n = 61
Value	29.51	32.79	26.67	32.79	16.39

CD5789 25 mcg/g Cream vs CD5789 Vehicle Cream: Percentage difference: 13.115 (95% CI -3.266 to 29.495), p = 0.096, Cochran-Mantel-Haenszel
CD5789 50 mcg/g Cream vs CD5789 Vehicle Cream: Percentage difference: 16.393 (95% CI -0.249 to 33.036), p = 0.040, Cochran-Mantel-Haenszel
CD5789 100 mcg/g Cream vs CD5789 Vehicle Cream: Percentage difference: 10.273 (95% CI -5.923 to 26.470), p = 0.184, Cochran-Mantel-Haenszel

Population analysed: Analysis was performed on Intent to treat (ITT) population that included all subjects who were randomized and to whom study drug was dispensed.

Primary outcome: Absolute Change From Baseline in Total Lesion Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)

Time frame: Baseline, Week 12. Least squares mean (Standard Error). Unit: lesion count

Measure	CD5789 25 mcg/g Cream n = 61	CD5789 50 mcg/g Cream n = 61	CD5789 100 mcg/g Cream n = 60	Tazarotene 0.1% Gel n = 61	Vehicle Cream n = 61
Value	-53.61 (8.314)	-54.75 (8.261)	-54.99 (8.296)	-59.84 (8.301)	-46.87 (7.934)

CD5789 25 mcg/g Cream vs Vehicle Cream: Percentage difference: -6.74 (95% CI -14.96 to 1.48), p = 0.108, ANCOVA
CD5789 50 mcg/g Cream vs Vehicle Cream: Percentage difference: -7.88 (95% CI -16.11 to 0.34), p = 0.060, ANCOVA
CD5789 100 mcg/g Cream vs Vehicle Cream: Percentage difference: -8.11 (95% CI -16.35 to 0.13), p = 0.054, ANCOVA

Population analysed: Analysis was performed on ITT population.

Primary outcome: Percentage Change From Baseline in Total Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: percentage change

Measure	CD5789 25 mcg/g Cream n = 61	CD5789 50 mcg/g Cream n = 61	CD5789 100 mcg/g Cream n = 60	Tazarotene 0.1% Gel n = 61	CD5789 Vehicle Cream n = 61
Value	-47.59 (28.474)	-49.87 (24.731)	-50.72 (24.885)	-55.07 (26.295)	-40.48 (28.968)

CD5789 25 mcg/g Cream vs CD5789 Vehicle Cream: p = 0.067, Cochran-Mantel-Haenszel
CD5789 50 mcg/g Cream vs CD5789 Vehicle Cream: p = 0.054, Cochran-Mantel-Haenszel
CD5789 100 mcg/g Cream vs CD5789 Vehicle Cream: p = 0.038, Cochran-Mantel-Haenszel

Population analysed: Analysis was performed on ITT population.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CD5789 25 mcg/g Cream	1 of 61 (1.6%)	15 of 61 (24.6%)	0 of 61
CD5789 50 mcg/g Cream	1 of 61 (1.6%)	17 of 61 (27.9%)	0 of 61
CD5789 100 mcg/g Cream	0 of 60 (0%)	23 of 60 (38.3%)	0 of 60
Tazarotene 0.1% Gel	0 of 61 (0%)	24 of 61 (39.3%)	0 of 61
CD5789 Vehicle Cream	1 of 61 (1.6%)	18 of 61 (29.5%)	0 of 61

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acne Vulgaris

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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.

Michael Graeber, M.D. study director

Galderma R&D, Inc.

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CD5789 25 µg/g cream, CD5789 50 µg/g cream and CD5789 100 µg/g cream in people with Acne Vulgaris, run by Galderma R&D at 24 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 10 inclusion and 4 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 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 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 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 20 Sep 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?

Percentage of Participants With Success Rate 1 (SR1) (time frame: From Baseline at 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 NCT01616654.

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 20 Sep 2021.