Table 1.
Summary of investigations comparing CTG combination therapy to monotherapy of clindamycin, tretinoin, or vehicle
| Study | Drug | Study design | Study length | Study size (n) | Major results | Safety/AE | Other comments |
|---|---|---|---|---|---|---|---|
| Rietschel and Duncan33 | Clindamycin 1% plus tretinoin 0.025% vs monotherapy of clindamycin or tretinoin | Double-blind, randomized | 8 weeks | 64 | Similar efficacy amongst tretinoin plus clindamycin, tretinoin alone, and clindamycin alone; all arms of the study were well-tolerated | Dryness and peeling worse with tretinoin alone; burning and erythema not significantly different between combination of drugs and tretinoin; clindamycin alone had least AEs | Absorption of cindamycin phosphate was not detected at 2 and 8 weeks; combination therapy had fewer subjective complaints |
| Leyden et al34 | CTG vs monotherapy of clindamycin or tretinoin or vehicle | Two randomized, double-blind, multicenter, active drug- and vehicle-controlled | 12 weeks | 2219 | CTG group showed superior efficacy in treating inflammatory and noninflammatory lesions compared with monotherapy or vehicle alone | Well-tolerated overall; 87.6% of participants reporting no AEs | Study conclusions may not represent predominantly inflammatory or nodulocystic acne; most subjects had noninflammatory acne |
| Yentzer et al28 | CTG vs application of two separate generic subcomponents | Single-blind, prospective, single center, randomized, controlled trial | 12 weeks | 21 | CTG group had significant reduction in total lesions over length of study; both groups improved mild to moderate acne | Treatment was well-tolerated in both groups | Adherence of CTG product exceeded that of using two separate medications |
| Richter et al35 | CTG vs 0.025% tretinoin gel | Randomized, double-blind, multicenter | 12 weeks | 152 | CTG was superior to tretinoin in papular and inflammatory acne lesions and in overall acne severity | Less burning reported with CTG | CTG onset of action was faster than tretinoin |
| Zouboulis et al36 | CTG vs clindamycin lotion | Multicenter, single-blind, randomized, comparative | 12 weeks | 206 | CTG was more effective at reducing acne lesions than clindamycin monotherapy | More erythema and desquamation reported with CTG | CTG had faster onset of action than clindamycin monotherapy |
Abbreviations: AE, adverse effect; CTG, clinamycin 1.0%–1.2%-tretinoin 0.025% combination gel.