Efficacy of a Novel Rosacea Treatment System: An Investigator-Blind, Randomized, Parallel-Group Study

October 2011 | Volume 10 | Issue 10 | Original Article | 1179 | Copyright © October 2011

James J. Leyden MD

KGL, Inc., Broomall, PA

0.75% topical gel in conjunction with a standard skin care regimen (a standard cleanser and standard moisturizer/sunscreen).


Adult females (at least 18 years of age) with mild or moderate erythema of rosacea on the malar area of their face were eligible to enroll in this investigator-blind, randomized, parallel-group study (see Table 1 for definitions of mild and moderate erythema).
Participants were required to be willing to refrain from using any non-study products on their face including medications, moisturizers, sunscreens, fragrances, and medicated make-up. However, they were allowed to use oil-free non-comedogenic make-up, mascara, eye liner, eye shadow, and lipstick as long as no new facial make-up products were introduced during the study. Participants were also required to avoid having facial procedures during the study—including facials, chemical peels, microdermabrasion, laser resurfacing, botulinum toxin type A injections, dermal filler injections, hair removal other than eyebrow plucking with tweezers, and non-ablative laser, light, or radiofrequency treatment. In addition, they were required to avoid tanning booth treatments and excessive sun exposure. They were instructed to apply the provided sunscreen daily and to wear protective clothing when exposed to the sun.
Exclusion criteria included: a history of any facial skin condition/ disease that might interfere with diagnosis or evaluation in the study; a nodular lesion or more than two inflammatory lesions (total of papules and pustules) on the face (because the study was evaluating the erythema of rosacea and inflammatory lesions can intensify erythema); known allergy or hypersensitivity to any ingredients in the study products; history or evidence of blood dyscrasia or Crohn's disease; current use of coumarin or warfarin; anticipated need for concurrent use of other medicated products on the face during the study; facial sunburn at baseline or sunbathing in the preceding two weeks; facial tattoos; and pregnancy, breastfeeding, or planning a pregnancy during the study.
The following washout periods were required: 1 week for medicated facial cleansers and facial hair removal; 2 weeks for topical medications or bleaching products on the face, photosensitizing medication or procedures, and UV light therapy; 3 weeks for topical tretinoin applied to the face; 4 weeks for vasodilators; 30 days for participation in an investigational drug or device study; 8 weeks for facial microdermabrasion; 12 weeks for chronic use of systemic steroids; 3 months for drugs known to be potentially toxic to a major organ; and 6 months for laser resurfacing and the use of acitretin, isotretinoin, methotrexate, and photoallergic, phototoxic, or photosensitizing drugs.
The protocol was approved by the relevant institutional review board and conducted in accordance with the Declaration of Helsinki (2004 version). All patients signed informed consent.
Treatment regimen
Patients were randomly assigned (in a 1:1:1 ratio) to receive one of the treatments detailed in Table 2 for 28 days: (1) the rosacea treatment system,3 (2) the rosacea treatment system omitting the metronidazole 0.75% topical gel, and (3) metronidazole 0.75% topical gel plus a standard skin care regimen (standard gentle cleanser plus standard moisturizer/sunscreen). The cleanser component of the rosacea treatment system contains aloe barbadensis leaf juice to cleanse the skin gently. The hydrating complexion corrector component of the rosacea treatment system is a moisturizing product containing anti-inflammatory ingredients and, in addition, light reflectors to camouflage redness and help balance the complexion.
Patients were instructed to apply each component of their treatment regimen in the order shown in Table 2. All study products were applied twice daily except the skin balancing sunscreen in the rosacea treatment system, which was applied each morning and as needed.
Outcome measures
The investigator performed a global assessment and assessed the level of erythema present (Table 1). The patients reported: their perception of the severity of their rosacea; the effectiveness of their study treatment in reducing dryness (compared with a baseline photograph); how comfortable their skin felt immediately after applying the study products; how easily their skin became irritated (for example, by products such as cosmetics, aftershaves, and cleansers); and their level of satisfaction with their study treatment (Table 1).
Statistical analyses
A Student's t-test was used to evaluate inter-group differences in erythema scores and rosacea severity scores. A paired t-test was used to evaluate intra-group differences in erythema scores and rosacea severity scores relative to baseline. An α-level of 0.05 was used to determine statistical significance.


Of 30 patients evaluated (10 per group), 29 (97%) completed. One patient (3%) withdrew due to an unwillingness to apply multiple products to the face (metronidazole plus standard skin care group). The patients' mean age was 45 years and all were Caucasian and had a Fitzpatrick skin type of I (30%), II (60%), or III (10%). At baseline, 77 percent considered their skin to be red and 67 percent considered their skin to be sensitive. The average time since the onset of their rosacea was 17 years.