Acne VulgarisPhase 2NCT01320033

Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions of Acne Vulgaris

A Phase 2 study testing CD2475/101 40 mg and Doxycycline 100 mg in people with Acne Vulgaris, run by Galderma R&D at 31 sites in United States.

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

The primary objectives of the study is to show CD2475/101 40mg tablets taken once a day for 16 weeks is superior to the placebo in Change from baseline to Week 16(Last Observation Carry Forward, Intent To Treat) in inflammatory lesion counts. 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?: CD2475/101 40 mg and Doxycycline 100 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 662 participants
Where: 31 sitesUnited States
Study dates: 29 Mar 2011to 3 Jan 2012
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 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male and female subjects 12 years of age or older
acne vulgaris with facial involvement
A score of 3 (Moderate) or 4 (Severe) on the Investigator's Global Assessment Scale (inflammatory)
25 to 75 inflammatory lesions (papules and pustules) on the face (including the nose)

Who cannot join

More than two acne nodules/cysts on the face
Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne, etc.), or severe acne requiring systemic retinoid treatment
Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea
Beard or facial hair which might interfere with study assessments
planning excessive exposure to sun or ultraviolet light during the study (i.e. natural or artificial sunlight, including tanning booths and sun lamp)
Use of oral contraceptives solely for control of acne

Show all 12Show fewer

Liver function test alanine transaminase (ALT) and/or aspartate transaminase (AST) 2.5 times above upper limit of normal
Renal function test serum creatinine at 150 umol/L (17 mg/L) or higher
Presence of oral or genital candidiasis or history of multiple episodes of oral or genital candidiasis
Females who intend to conceive a child within 5 months following Baseline visit
Males who intend to conceive a child with partner during the study period
Requiring concomitant use of methoxyflurane

Trial locations and contacts

31 sites in 1 country.

City, postcode or hospital

31 sites in 1 country

United States31 sites

Academic Dermatology
Albuquerque, New Mexico, 87106
Arlington Center for Dermatology
Arlington, Texas, 76011
Derm Research, Inc
Austin, Texas, 78759
J&S Studies
College Station, Texas, 77845
Colorado Medical Research Center
Denver, Colorado, 80210
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, 29607
Stephen Schleicher
Hazleton, Pennsylvania, 18201
Dermatology Consulting Services
High Point, North Carolina, 27262
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Suzanne Bruce and associates P.A. The Center for skin Research
Houston, Texas, 77056
Center for Clinical Studies
Houston, Texas, 77058
Longmont Medical Research Network
Longmont, Colorado, 80501
Dermatology Research Associates, Inc.
Los Angeles, California, 90045
Dermatology Specialists PC
Louisville, Kentucky, 40202
International Dermatology Research, Inc.
Miami, Florida, 33144
Dermatology Research Associates
Nashville, Tennessee, 37203
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
MedaPhase, Inc.
Newnan, Georgia, 30263
Central Sooner Research
Norman, Oklahoma, 73069
Skin Specialists, PC
Omaha, Nebraska, 68144
Oregon Dermatology & Research Center
Portland, Oregon, 97210
Helendale Dermatology & Medical Spa
Rochester, New York, 14609
Dermatology Research Center
Salt Lake City, Utah, 84124
Progressive Clinical Research
San Antonio, Texas, 78229
Stephen Miller MD
San Antonio, Texas, 78229
Haber Dermatology & cosmetic Surgery, Inc
South Euclid, Ohio, 44118
Premier Clinical Research
Spokane, Washington, 99204
Central Dermatology, PC
St Louis, Missouri, 63117
Somerset Skin Care Center
Troy, Michigan, 48084
Grekin Skin Care
Warren, Michigan, 48088
PMG Research of Wilmington
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Multi Center, Randomized, Double Blind, Placebo Controlled, 3 Arm, Parallel Group Study Comparing the Efficacy and Safety of CD2475/101 40 mg Tablets Versus Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions in Subjects With Acne Vulgaris

Read the detailed description

Investigator's global assessment and lesion count will be performed at each study visit.

Conditions: Acne Vulgaris
Being tested: CD2475/101 40 mg, Doxycycline 100 mg, Placebo
Keywords: acne vulgaris, inflammatory lesions
Medical subject headings: Acne Vulgaris

What participants receive

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

CD2475/101 40 mgDrug
Participants receive 40 mg of CD2475/101 tablets once a day for 16 weeks.
Doxycycline 100 mgDrug
Participants receive 100 mg of Doxycycline capsule once a day for 16 weeks
PlaceboDrug
Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.

Study groups in NCT01320033
Study group	Role	What they receive
CD2475/101 40 mg	Experimental	Participants receive 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks. Receives: Drug: CD2475/101 40 mg; Drug: Placebo
Doxycycline 100 mg	Active comparator	Participants receive 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks. Receives: Drug: Doxycycline 100 mg; Drug: Placebo
Placebo	Placebo comparator	Participants receive matching placebo tablet plus placebo capsule orally once daily for 16 weeks. Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported.
Measured: From Baseline up to Week 16 (LOCF)

Secondary outcomes (6)

Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF])
IGA scale consisted of 5 grades (0-4) among which 0= Clear (no evidence of papules or pustules [inflammatory lesions]), 1= Almost clear (rare non-inflamed papules (papules must be resolving and hyperpigmented, though not pink-red), 2= Mild (few inflammatory lesions [papules/pustules only; no nodulo-cystic lesions]), 3=Moderate (multiple inflammatory lesions evident: many papules/pustules; up to two nodulocystic lesions), 4= Severe (inflammatory lesions are more apparent, many papules/pustules, few nodulo-cystic lesions). Success rate was defined as percentage of participants who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 16 (LOCF).
Measured: Week 16 (LOCF)
Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Percent change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported.
Measured: From Baseline up to Week 16 (LOCF)
Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
Total lesions were the sum of inflammatory lesion counts, non-inflammatory lesion counts, nodules and cysts. Percentage change from baseline in total lesion counts to Week 16 were reported.
Measured: From Baseline up to Week 16 (LOCF)
Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
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). Change from baseline in non-inflammatory lesion counts to week 16 were reported
Measured: From Baseline up to Week 16 (LOCF)
Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16
Global assessments for inflammatory lesions of truncal acne were done separately on back and chest. The global assessments severity scale included 5 grades (0-4): where in 0= Clear-no evidence of papules or pustules (inflammatory lesions), 1= Almost clear- rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red), 2=Mild- few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions), 3=Moderate- multiple inflammatory lesions evident: many papules/pustules; may be a few nodulocystic lesions, 4=Severe- inflammatory lesions are more apparent, many papules/pustules, may be a few nodulo-cystic lesions.
Measured: Baseline, Week 12, and Week 16
Number of Participants With at Least One Adverse Event (AE)
An AE was any untoward medical occurrence in a participant or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Number of participants with at least one AE were reported.
Measured: From Baseline up to Week 16

Timeline

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

29 Mar 20113 Jan 2012

First posted22 Mar 2011 (estimated)
Study start29 Mar 2011
Primary completion3 Jan 2012
Study completion3 Jan 2012

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: 662 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01320033
Sponsor's protocol ID: RD.06.SPR.18195
Status last verified: Dec 2019
First submitted: 21 Mar 2011
Last updated: 18 Feb 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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Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi Center, Randomized, Double Blind, Placebo Controlled, 3 Arm, Parallel Group Study Comparing the Efficacy and Safety of CD2475/101 40 mg Tablets Versus Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions in Subjects With Acne Vulgaris
ClinicalTrials.gov ID: NCT01320033
Acronym / sponsor ID: RD.06.SPR.18195
Conditions: Acne Vulgaris
Keywords: acne vulgaris, inflammatory lesions
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 662 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 29 Mar 2011 (actual)
Primary completion: 3 Jan 2012 (actual)
Study completion: 3 Jan 2012 (actual)
First posted: 22 Mar 2011 (estimated)
Results: Posted 10 Feb 2020

Clinical summary

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

Detailed description

Investigator's global assessment and lesion count will be performed at each study visit.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
CD2475/101 40 mg	Experimental	Drug: CD2475/101 40 mg, Drug: PlaceboParticipants receive 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
Doxycycline 100 mg	Active comparator	Drug: Doxycycline 100 mg, Drug: PlaceboParticipants receive 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
Placebo	Placebo comparator	Drug: PlaceboParticipants receive matching placebo tablet plus placebo capsule orally once daily for 16 weeks.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Male and female subjects 12 years of age or older
acne vulgaris with facial involvement
A score of 3 (Moderate) or 4 (Severe) on the Investigator's Global Assessment Scale (inflammatory)
25 to 75 inflammatory lesions (papules and pustules) on the face (including the nose)

Key exclusion criteria (12 listed)

More than two acne nodules/cysts on the face
Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne, etc.), or severe acne requiring systemic retinoid treatment
Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea
Beard or facial hair which might interfere with study assessments
planning excessive exposure to sun or ultraviolet light during the study (i.e. natural or artificial sunlight, including tanning booths and sun lamp)

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
CD2475/101 40 mgParticipants receive 40 mg of CD2475/101 tablets once a day for 16 weeks.	Drug	CD2475/101 40 mg
Doxycycline 100 mgParticipants receive 100 mg of Doxycycline capsule once a day for 16 weeks	Drug	Doxycycline 100 mg
PlaceboParticipants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.	Drug	CD2475/101 40 mg, Doxycycline 100 mg, Placebo

Primary outcome

Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline up to Week 16 (LOCF)
The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported.

6 secondary outcomes

Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF])
Time frame: Week 16 (LOCF)
Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline up to Week 16 (LOCF)
Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline up to Week 16 (LOCF)
Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline up to Week 16 (LOCF)
Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16
Time frame: Baseline, Week 12, and Week 16
Number of Participants With at Least One Adverse Event (AE)
Time frame: From Baseline up to Week 16

Results and safety

Results posted to the registry on 10 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CD2475/101 40 mg	216	158
Doxycycline 100 mg	224	160
Placebo	222	169

Primary outcome: Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])

Time frame: From Baseline up to Week 16 (LOCF). Mean (Standard Deviation). Unit: lesion count

Measure	CD2475/101 40 mg n = 216	Doxycycline 100 mg n = 224	Placebo n = 222
Value	-16.1 (11.39)	-12.9 (14.60)	-12.6 (16.44)

CD2475/101 40 mg vs Placebo: Mean Difference (Final Values): -3.6 (95% CI -6.1 to -1.1), p = 0.006, ANCOVA
CD2475/101 40 mg vs Doxycycline 100 mg: Mean Difference (Final Values): -2.9 (95% CI -5.4 to -0.4), p = 0.024, ANCOVA
Doxycycline 100 mg vs Placebo: Mean Difference (Final Values): -0.7 (95% CI -3.2 to 1.8), p = 0.595, ANCOVA

Population analysed: Intent To Treat (ITT) population consisted of all participants who were randomized and to whom study drug was dispensed.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline up to Week 16. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CD2475/101 40 mg	1 of 216 (0.5%)	29 of 216 (13.4%)	0 of 216
Doxycycline 100 mg	4 of 223 (1.8%)	51 of 223 (22.9%)	0 of 223
Placebo	2 of 222 (0.9%)	29 of 222 (13.1%)	0 of 222

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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, MD study director

Galderma R&D

31 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 CD2475/101 40 mg and Doxycycline 100 mg in people with Acne Vulgaris, run by Galderma R&D at 31 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 12 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 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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 10 Feb 2020). 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?

Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) (time frame: From Baseline up to Week 16 (LOCF)). 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 NCT01320033.

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 Feb 2021.