A Phase 3 interventional study of CT Gel and Clindamycin Gel (clindamycin ) in Acne Vulgaris and Acne, sponsored by Stiefel, a GSK Company. Completed at 32 sites in 3 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2017-05-30.
Sponsored by Stiefel, a GSK Company (part of GlaxoSmithKline) · Phase 3, Interventional, and Treatment
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.
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.
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's enrollment of 1,649 is above the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Stiefel, a GSK Company is the lead sponsor of 56 studies on the registry; none are open to participants now.
First submitted before Stiefel became part of GlaxoSmithKline.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CT Gel
Drug: CT Gel
Clindamycin Gel (clindamycin)
Drug: Clindamycin Gel (clindamycin )
Tretinoin Gel (tretinoin)
Drug: Tretinoin Gel (tretinoin)
Vehicle Gel
Drug: Vehicle Gel
Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks
Clindamycin 1% gel applied topically once daily in the evening for 12 weeks
Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks
Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks
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.
Time frame: 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.
Time frame: Baseline, Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 12
| Milestone | CT Gel | Clindamycin Gel | Tretinoin Gel | Vehicle Gel |
|---|---|---|---|---|
| Started | 476 | 467 | 464 | 242 |
| Completed | 414 | 416 | 405 | 211 |
| Not completed | 62 | 51 | 59 | 31 |
| Withdrew: Adverse event | 6 | 0 | 5 | 0 |
| Withdrew: Lost to follow-up | 26 | 19 | 17 | 11 |
| Withdrew: Lack of efficacy | 1 | 2 | 2 | 2 |
| Withdrew: Non-compliance with study treatment | 3 | 3 | 3 | 1 |
| Withdrew: Withdrawal by subject | 19 | 18 | 26 | 13 |
| Withdrew: Unable to comply with visit schedule | 0 | 0 | 1 | 1 |
| Withdrew: Inclusion/exclusion criteria not met | 1 | 2 | 0 | 0 |
| Withdrew: Non-compliance with treatment regimen | 0 | 1 | 0 | 0 |
| Withdrew: Change/discontinuation of birth control | 1 | 1 | 1 | 0 |
| Withdrew: Use of prohibitive medication | 2 | 1 | 3 | 0 |
| Withdrew: Pregnancy | 0 | 2 | 0 | 2 |
| Withdrew: Incarceration | 2 | 0 | 0 | 0 |
| Withdrew: Fear of birth defects | 0 | 0 | 1 | 0 |
| Withdrew: Transportation | 1 | 0 | 0 | 0 |
| Withdrew: Patient withdrew from study | 0 | 0 | 0 | 1 |
| Withdrew: Personal reason | 0 | 1 | 0 | 0 |
| Withdrew: Dispensing error | 0 | 1 | 0 | 0 |
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.
| lesions | CT Gel | Clindamycin Gel | Tretinoin Gel | Vehicle Gel |
|---|---|---|---|---|
| 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 |
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.
| percentage of participants | CT Gel | Clindamycin Gel | Tretinoin Gel | Vehicle Gel |
|---|---|---|---|---|
| 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 | 36.3 | 26.6 | 26.1 | 20.2 |
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.
| percent change | CT Gel | Clindamycin Gel | Tretinoin Gel | Vehicle Gel |
|---|---|---|---|---|
| Inflammatory Lesions | -60.5 ± 36.21 | -56.6 ± 44.99 | -54.5 ± 39.19 | -43.3 ± 44.9 |
| Non-Inflammatory Lesions | -51.1 ± 33.02 | -42.9 ± 36.6 | -47.3 ± 43.5 | -36.0 ± 39.14 |
| Total Lesions | -55.0 ± 30.47 | -49.0 ± 30.08 | -50.6 ± 34.82 | -39.1 ± 36.48 |
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.
| participants | CT Gel | Clindamycin Gel | Tretinoin Gel | Vehicle Gel |
|---|---|---|---|---|
| The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12 | 62 | 60 | 62 | 50 |
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.
| percentage of participants | CT Gel | Clindamycin Gel | Tretinoin Gel | Vehicle Gel |
|---|---|---|---|---|
| The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12 | 43.1 | 36.6 | 33.8 | 22.7 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CT Gel | — | 1/476 (0.2%) | 27/476 (5.7%) |
| Clindamycin Gel | — | 1/467 (0.2%) | 34/467 (7.3%) |
| Tretinoin Gel | — | 3/464 (0.6%) | 27/464 (5.8%) |
| Vehicle Gel | — | 1/242 (0.4%) | 18/242 (7.4%) |
| Event | CT Gel | Clindamycin Gel | Tretinoin Gel | Vehicle Gel |
|---|---|---|---|---|
| BronchitisInfections and infestations | 0/476 | 0/467 | 0/464 | 1/242 |
| ConcussionInjury, poisoning and procedural complications | 0/476 | 0/467 | 1/464 | 0/242 |
| Suicide attemptPsychiatric disorders | 0/476 | 0/467 | 1/464 | 0/242 |
| Ovarian cystReproductive system and breast disorders | 0/476 | 0/467 | 1/464 | 0/242 |
| Abdominal painGastrointestinal disorders | 0/476 | 1/467 | 0/464 | 0/242 |
| Infectious mononucleosisInfections and infestations | 1/476 | 0/467 | 0/464 | 0/242 |
| Event | CT Gel | Clindamycin Gel | Tretinoin Gel | Vehicle Gel |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 27/476 | 34/467 | 27/464 | 18/242 |
| Age, Continuous(years) | CT Gel | Clindamycin Gel | Tretinoin Gel | Vehicle Gel | Total |
|---|---|---|---|---|---|
| Mean | 20.8 ± 8.5 | 20.2 ± 8.1 | 20.2 ± 7.7 | 20.6 ± 8.4 | 20.4 ± 8.1 |
| Sex: Female, Male(Participants) | CT Gel | Clindamycin Gel | Tretinoin Gel | Vehicle Gel | Total |
|---|---|---|---|---|---|
| Female | 269 | 266 | 264 | 153 | 952 |
| Male | 207 | 201 | 200 | 89 | 697 |
| Race/Ethnicity, Customized(participants) | CT Gel | Clindamycin Gel | Tretinoin Gel | Vehicle Gel | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 4 | 4 | 4 | 3 | 15 |
| Asian | 8 | 8 | 11 | 5 | 32 |
| Black | 94 | 85 | 103 | 51 | 333 |
| Multiracial | 12 | 16 | 19 | 5 | 52 |
| Native Hawaiian/Other Pacific Islander | 0 | 4 | 2 | 1 | 7 |
| White | 358 | 349 | 324 | 176 | 1207 |
| Missing | 0 | 1 | 1 | 1 | 3 |
The record gives a start of Apr 2008, a primary completion of Apr 2009 and a completion of May 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2010, 1 year 8 months after primary completion. A results delay was requested in Sep 2010.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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