Acne VulgarisPhase 3NCT00689117

A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel

A Phase 3 study testing CT Gel, Clindamycin Gel (clindamycin ) and Tretinoin Gel (tretinoin) in people with Acne Vulgaris and Acne, run by Stiefel, a GSK Company at 32 sites in 3 countries.

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

The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Acne Vulgaris, Acne
What is being tested?: CT Gel, Clindamycin Gel (clindamycin ) and Tretinoin Gel (tretinoin)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,649 participants
Where: 32 sitesin 3 countries
Study dates: Apr 2008to May 2009
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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or female 12 years of age or older in good general health
Investigator's Static Global Assessment (ISGA) score of 2 or greater at Baseline

Who cannot join

Any nodulo-cystic lesions at Baseline
Pregnancy or breast feeding
History or presence of regional enteritis or inflammatory bowel disease or similar symptoms.
Treatment with estrogens, including oral, implanted and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or less prior to study start.
Use of topical anti-acne medications within the past 2 weeks.
Use of topical or systemic antibiotics on the face within the past 2 weeks.

Show all 18Show fewer

Use of topical or systemic corticosteroids within the past 2 weeks.
Use of systemic retinoids within the past 3 months.
Use of astringents, toners and skin cleansers for less than 2 weeks prior to the start of the study.
Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids.
Concomitant use of mega-doses of certain vitamins, such as vitamin D (>2000IU QD) vitamin B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.
Concomitant use of tanning booths or sunbathing.
Known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, retinoids or excipients of the study product
A significant medical history of or are currently immunocompromised
Current drug or alcohol abuse. (Drug screening not required.)
Use of any investigational therapy within 4 weeks of enrollment.
Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.

Trial locations and contacts

32 sites in 3 countries.

Country

City, postcode or hospital

32 sites in 3 countries

United States27 sites

Academic Dermatology Research
Albuquerque, New Mexico, 87106
University of Michigan
Ann Arbor, Michigan, 48109
DermResearch, Inc.
Austin, Texas, 78759
Radiant Research
Birmingham, Alabama, 35209
Massachusettes General Hospital - Clinical Unit for Research Trials in Skin
Boston, Massachusetts, 02114
Dermatology Research Associates, Inc.
Cincinnati, Ohio, 45230
J & S Studies, Inc.
College Station, Texas, 77840
The Hair and Skin Research Treatment Center
Dallas, Texas, 75246
Henry Ford Medical Center
Detroit, Michigan, 48202
Center for Dermatology, Cosmetic and Laser Surgery
Fremont, California, 94538
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Clinical Partners, LLC
Johnston, Rhode Island, 02919
Dermatology Associates of Knoxville, P.C.
Knoxville, Tennessee, 37934
Longmont Medical Research Network
Longmont, Colorado, 80501
Dermatology Specialists
Louisville, Kentucky, 40202
FXM Research Corporation
Miami, Florida, 33175
Advanced Healthcare
Milwaukee, Wisconsin, 53209
FXM Research - Miramar
Miramar, Florida, 33027
Coastal Clinical Research, Inc.
Mobile, Alabama, 33608
Tennessee Clinical Research
Nashville, Tennessee, 37215
Skin Specialists, P.C.
Omaha, Nebraska, 68144
Advanced Dermatolgy & Cosemtic Surgery
Ormond Beach, Florida, 32174
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124
University Clinical Trials
San Diego, California, 92103
Premier Clincial Research
Spokane, Washington, 99204
Yardley Dermatology Associates
Yardley, Pennsylvania, 19067

Other trials in United States

Canada3 sites

Innovaderm Research, Inc.
Montreal, Quebec, H2K 4L5
K. Papp Clinical Research, Inc.
Waterloo, Ontario, N2J 1C4
Windsor Clinical Research Center, Inc.
Windsor, Ontario, N8W 5L7

Other trials in Canada

Belize2 sites

Dermatology And Skin Centre
Belize City
Dr. Moguel's Clinic
Belize City

About this study

Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of CT Gel in Subjects With Acne Vulgaris

Read the detailed description

CT Gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. Based on numerous nonclinical pharmacology studies of each active ingredient, it is expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory.

Conditions: Acne Vulgaris, Acne
Being tested: CT Gel, Clindamycin Gel (clindamycin ), Tretinoin Gel (tretinoin), Vehicle Gel
Keywords: Acne Vulgaris, Acne
Medical subject headings: Acne Vulgaris

What participants receive

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

CT GelDrug
Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks
Clindamycin Gel (clindamycin )Drug
Clindamycin 1% gel applied topically once daily in the evening for 12 weeks
Tretinoin Gel (tretinoin)Drug
Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks
Vehicle GelDrug
Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks

Study groups in NCT00689117
Study group	Role	What they receive
1	Experimental	CT Gel Receives: Drug: CT Gel
2	Active comparator	Clindamycin Gel (clindamycin) Receives: Drug: Clindamycin Gel (clindamycin )
3	Active comparator	Tretinoin Gel (tretinoin) Receives: Drug: Tretinoin Gel (tretinoin)
4	Placebo comparator	Vehicle Gel Receives: Drug: Vehicle Gel

What is being measured

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

Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)
Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.
Measured: Baseline, Week 12
The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value.
Measured: Baseline, Week 12

Secondary outcomes (3)

Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12
Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.
Measured: Baseline, Week 12
The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12
The SGA score is a global evaluation of acne severity performed by participants at all visits and measured on a 5-point ordinal scale, where 0=My face is basically free of acne and 5=My face has blackheads and/or whiteheads. A score of 1=My face has several blackheads and/or whiteheads and small pimples, but there are no tender deep-seated bumps or cysts.
Measured: Week 12
The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12
The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. A score of 1=Skin Almost Clear: rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyper-pigmented, though not pink-red) requiring no futher treatment in the Investigator's opinion.
Measured: Week 12

Timeline

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

Apr 2008May 2009

First posted3 Jun 2008 (estimated)
Study startApr 2008
Primary completionApr 2009
Study completionMay 2009

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,649 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00689117
Sponsor's protocol ID: 114681
Other IDs: W0265-03
Status last verified: May 2017
First submitted: 24 May 2008
Last updated: 30 May 2017
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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RecruitingPhase 4
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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of CT Gel in Subjects With Acne Vulgaris
ClinicalTrials.gov ID: NCT00689117
Acronym / sponsor ID: 114681
Conditions: Acne Vulgaris, Acne
Keywords: Acne Vulgaris, Acne
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,649 participants (actual)
Lead sponsor: Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: Apr 2008
Primary completion: Apr 2009 (actual)
Study completion: May 2009 (actual)
First posted: 3 Jun 2008 (estimated)
Results: Posted 2 Dec 2010

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: CT GelCT Gel
2	Active comparator	Drug: Clindamycin Gel (clindamycin )Clindamycin Gel (clindamycin)
3	Active comparator	Drug: Tretinoin Gel (tretinoin)Tretinoin Gel (tretinoin)
4	Placebo comparator	Drug: Vehicle GelVehicle Gel

Who may qualify

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

Key inclusion criteria (2 listed)

Male or female 12 years of age or older in good general health
Investigator's Static Global Assessment (ISGA) score of 2 or greater at Baseline

Key exclusion criteria (18 listed)

Any nodulo-cystic lesions at Baseline
Pregnancy or breast feeding
History or presence of regional enteritis or inflammatory bowel disease or similar symptoms.
Treatment with estrogens, including oral, implanted and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or less prior to study start.
Use of topical anti-acne medications within the past 2 weeks.

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
CT GelTopical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks	Drug	1
Clindamycin Gel (clindamycin )Clindamycin 1% gel applied topically once daily in the evening for 12 weeks	Drug	2
Tretinoin Gel (tretinoin)Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks	Drug	3
Vehicle GelTopical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks	Drug	4

Primary outcome

Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)
Time frame: Baseline, Week 12
Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.
The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
Time frame: Baseline, Week 12
The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value.

3 secondary outcomes

Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12
Time frame: Baseline, Week 12
The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12
Time frame: Week 12
The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12
Time frame: Week 12

Results and safety

Results posted to the registry on 2 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CT Gel	476	414
Clindamycin Gel	467	416
Tretinoin Gel	464	405
Vehicle Gel	242	211

Primary outcome: Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)

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

Measure	CT Gel n = 476	Clindamycin Gel n = 467	Tretinoin Gel n = 464	Vehicle Gel n = 242
Inflammatory Lesion Counts	-15.5 (10.33)	-14.5 (9.37)	-13.9 (11.05)	-11.1 (11.70)
Non-Inflammatory Lesion Counts	-23.2 (20.41)	-19.5 (19.72)	-22.1 (21.75)	-17.0 (20.58)
Total Lesion Counts	-38.7 (26.80)	-34.0 (25.16)	-36.0 (28.26)	-28.1 (27.26)

CT Gel vs Clindamycin Gel: p = 0.063, Ranked ANCOVA
CT Gel vs Tretinoin Gel: p = 0.003, Ranked ANCOVA
CT Gel vs Vehicle Gel: p <0.001, Ranked ANCOVA

Population analysed: Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least one application of study product.

Primary outcome: The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12

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

Measure	CT Gel n = 476	Clindamycin Gel n = 467	Tretinoin Gel n = 464	Vehicle Gel n = 242
Value	36.3	26.6	26.1	20.2

CT Gel vs Clindamycin Gel: p = 0.001, Cochran-Mantel-Haenszel
CT Gel vs Tretinoin Gel: p <0.001, Cochran-Mantel-Haenszel
CT Gel vs Vehicle Gel: p <0.001, Cochran-Mantel-Haenszel

Population analysed: ITT Population

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CT Gel	1 of 476 (0.2%)	27 of 476 (5.7%)	Not reported
Clindamycin Gel	1 of 467 (0.2%)	34 of 467 (7.3%)	Not reported
Tretinoin Gel	3 of 464 (0.6%)	27 of 464 (5.8%)	Not reported
Vehicle Gel	1 of 242 (0.4%)	18 of 242 (7.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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.

GSK Clinical Trials study director

GlaxoSmithKline

32 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CT Gel, Clindamycin Gel (clindamycin ) and Tretinoin Gel (tretinoin) in people with Acne Vulgaris and Acne, run by Stiefel, a GSK Company at 32 sites in 3 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 2 inclusion and 18 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Canada, Belize. 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 2 Dec 2010). 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 Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) (time frame: Baseline, 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 NCT00689117.

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 30 May 2017.