Phase 3
Completed N=1,649
A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel
Source: ClinicalTrials.gov NCT00689117 ↗Enrolled (actual)
1,649
Serious AEs
0.4%
Results posted
Dec 2010
Primary outcomePrimary: Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) — -15.5; -14.5; -13.9; -11.1 lesions — p=0.063
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) |
-15.5; -14.5; -13.9; -11.1; -23.2; -19.5 | 0.063 |
| PRIMARY 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 | 0.001 sig |
| SECONDARY Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 |
-60.5; -56.6; -54.5; -43.3; -51.1; -42.9 | 0.065 |
| SECONDARY The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12 |
62; 60; 62; 50 | 0.671 |
| SECONDARY The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12 |
43.1; 36.6; 33.8; 22.7 | 0.002 sig |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT00689117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.