Clinical Trials Resource Center


September 19, 2016

Foamix Pharmaceuticals issued results of a phase II trial of FMX103 for papulopustular rosacea. The double-blind, randomized, placebo-controlled trial included 233 subjects with moderate-to-severe rosacea. Subjects were randomized to receive either one of two doses of FMX103 minocycline foam (3% or 1.5%) or vehicle foam once daily over 12 weeks, followed up by a four-week post-treatment evaluation. The efficacy endpoints were the absolute change in the number of inflammatory lesions papules and pustules and improvement of the Investigator Global Assessment of severity (IGA). At week 12, the 1.5% and 3% doses of FMX103 both significantly reduced the number of papules and pustules vs. the vehicle (1.5% and 3%, both p<0.001, ANCOVA, intent-to-treat analysis). The mean reduction in lesion count of each treatment group vs. its baseline was 21.1 for the 1.5% dose, 19.9 for the 3% dose and 7.8 for vehicle; the corresponding percent reductions were 61.4% and 55.5% for the FMX103 1.5% and 3% groups, respectively, and 29.7% for the vehicle. Both the 1.5% and 3% doses of FMX-103 were significantly better compared to vehicle in reducing the IGA score by two grades and in reaching a “clear” (score=0) or “almost clear” (score=1) rating at week 12 (p<0.01 and p<0.05, respectively, CochranMantelHaenszel test). Both the 1.5% and 3% doses were efficacious and there was no statistically significant difference between doses. FMX103 appeared to be generally safe and well-tolerated. There were no serious treatment-related AEs and few subjects overall reported any treatment-related AEs (two, four and five in the 1.5%, 3% and vehicle groups, respectively).

March 31, 2014

Galderma Laboratories released results of two phase III trials of ivermectin 1% for the treatment of papulopustular (inflammatory) rosacea. Both studies were randomized, double-blind, 12-week vehicle-controlled, parallel–group studies enrolling a total of 910 subjects. In Study 1, 173 subjects (38.4%) were assessed as success with ivermectin 1% v. 27 subjects (11.6%) with vehicle (p<0.001). Statistical significance was observed from week four with success in 49 (10.9%) and 13 (5.6%) patients for ivermectin 1% and vehicle, respectively. The results were consistent between the studies. In both studies, ivermectin 1% showed comparable tolerability and safety to the control group vehicle. In Studies 1 and 2 in the ivermectin 1% cream group, 4.2% and 2.6% of patients, respectively, who reported adverse events (AEs) were considered to have AEs related to study treatment. In the vehicle group, 7.8% and 6.5% of reported AEs were treatmentrelated AEs respectively. There were no treatment-related serious AEs.

October 24, 2011

Galderma issued preliminary results from a phase IIb trial of CD07805/47 for moderate to severe facial erythema associated with rosacea. This randomized, double-blind, parallel-group, placebo-controlled trial enrolled 260 subjects who received CD07805/47 gel 0.5% applied topically once daily, CD07805/47 gel 0.18% applied topically once daily or twice daily or placebo. CD07805/47 was shown to be rapidly effective at reducing facial redness and there was no evidence of tachyphylaxis, or rebound. It was safe and well-tolerated.

April 25, 2011

Vicept released results from a phase II trial of V-101 for the treatment of erythematous rosacea. This randomized, multi-centered, double-blinded, placebo-controlled trial, V-101-ROSE-206, enrolled 85 subjects with moderate to severe erythema who received one of two concentrations of V-101 cream or placebo cream. The results demonstrated a statistically significant improvement in the primary endpoint, a reduction in facial erythema or redness over a twelve hour period, versus placebo cream (p<0.01). V-101 demonstrated a safety profile similar to placebo cream.

January 17, 2011

Vicept Therapeutics reported positive results from a phase II trial of V-101, a topical cream for the treatment of Erythematotelangiectatic Rosacea. The randomized, multi-centered, double-blinded, placebo-controlled trial, V-101-ROSE-202, enrolled 183 subjects with moderate to severe erythema. The subjects were divided among five groups and self-administered one of four concentrations of V-101 cream or placebo cream once daily for 28 days. The results demonstrated a statistically significant (p≡0.0006) improvement in the primary end point, which was a reduction in facial erythema, over an eight hour period versus placebo. V-101 demonstrated a safety profile similar to placebo cream and no evidence of tachyphylaxis was observed.

May 12, 2008

Senetek issued positive results from a phase I trial of Pyratine-6 for the treatment of acne rosacea. This study enrolled 24 subjects with mild-to-moderate acne rosacea. They were evaluated at baseline, four, eight and twelve weeks for physician assessments of inflammatory lesion count, severity of erythema and telangiectasia, transepidermal water loss measurements and overall clinical improvement. Pyratine-6 produced a progressive decrease in the symptoms associated with rosacea including redness and acne lesions. All subject self-assessments showed good tolerability and cosmetic acceptability. After 12 weeks there was overall clinical improvement in 80% of subjects, including reduction of erythema and papules. Transepidermal water loss measurements showed a 22% decrease in water loss, which supports an improvement in skin barrier function. Based on these results, Senetek extended this study to 48 weeks.

January 21, 2008

CollaGenex reported positive results from a phase IV trial of Oracea for the treatment of rosacea. This prospectively randomized, double-blinded, placebo-controlled clinical study enrolled ninety one subjects in the US. The subjects were treated once daily with either doxycycline (100 mg) or Oracea (40 mg doxycycline, controlled release), both as an adjunct to topical MetroGel 1%, for sixteen weeks. Efficacy and adverse events were evaluated at baseline and at weeks four, eight, twelve and sixteen. The objective of the study was to demonstrate that increasing the dose of doxycycline above the anti-inflammatory levels provided by Oracea does not provide any additional benefit but significantly adds to the adverse event profile. The primary endpoint was the mean change in total inflammatory lesion count from baseline to the week sixteen. The subjects in the Oracea arm had an average of 19.8 inflammatory lesions at baseline and experienced a decrease in lesion count of 12.5 lesions, compared with 17.7 lesions at baseline and a decrease of 12.2 lesions in the doxycycline, 100 mg group. In addition, there were no differences observed between the treatment groups regarding the secondary endpoints of Investigators Global Assessment and Clinician's Erythema Assessment with (p-values of 0.86 and 0.50, respectively). A clear difference in the incidence of adverse events, primarily gastrointestinal reactions, was observed between the treatment groups. Nausea, vomiting, diarrhea and stomach discomfort were observed in 26% of subjects administered 100 mg of doxycycline versus only 5% in the Oracea group. Oracea is currently under investigation for the treatment of periodontal disease.

October 22, 2007

Cutanea Life Sciences issued positive results from a phase II trial of omiganon for the treatment of rosacea. This randomized, placebo-controlled, double-blind, multi-center trial enrolled 240 subjects with papulopustular rosacea in the US. The subjects received omiganan 1% once daily (QD), omiganan 2.5% QD, omiganan 2.5% twice-daily (BID), placebo QD, or placebo BID, all for a duration of nine weeks. Safety and efficacy assessments were performed at weeks one, three, six, and nine. The primary efficacy endpoint was mean percent reduction in the number of inflammatory lesions from Baseline to Week 9. The subjects receiving omiganan 2.5% QD, showed a mean 31% reduction in the number of inflammatory facial lesions compared to a 14% reduction in those receiving placebo QD. Among subjects with 18 or more lesions at Baseline, the mean reduction for once-daily omiganan 2.5% was 40%, compared to an 11% lesion increase in the once-daily placebo group. Treatment was well tolerated at all doses tested. Based on the results phase III trials are expected to commence shortly.

Johnson & Johnson announced positive results from a phase III trial of CNTO1275 for the treatment of psoriasis. This randomized, double-blind, placebo-controlled study, dubbed PHOENIX 2, enrolled 1,230 subjects with chronic psoriasis. The subjects received CNTO1275 administered subcutaneously or placebo. In the CNTO1275 arm, the subjects received 45 mg or 90 mg doses at weeks 0 and 4 followed by the same dose every 12 weeks. Those in the placebo arm crossed over to receive either 45 mg or 90 mg doses of CNTO1275 at weeks 12 and 16 and every subsequent 12 weeks. The primary endpoint was the proportion of subjects who achieved a Psoriasis Area and Severity Index (PASI) score of 75 at week 12. By week 12, 67% of the subjects treated with 45 mg of CNTO1275 and 76% of those treated with 90 mg of CNTO1275 achieved PASI75 compared with 4% of those treated with placebo (p < 0.001). In addition, 42% of the subjects in the 45 mg arm and 51% in the 90 mg arm achieved a PASI 90, or almost complete clearance of psoriasis, compared to 1% in the placebo arm (p < 0.001). Comparable results were seen in the placebo group 12 weeks after crossover to CNTO1275. Following an additional dose at week 16, responses were maintained through week 28. Treatment was well tolerated, with adverse events comparable between the CNTO1275 and placebo groups. Additional phase III trials are currently underway.

February 12, 2007

CollaGenex reported positive results from a phase IV trial of Oracea plus topical MetroGel for the treatment of rosacea. This double-blind, placebo-controlled trial enrolled a total of 72 rosacea subjects who received either Oracea capsules plus MetroGel or placebo capsules plus MetroGel once a day for 12 weeks. MetroGel was discontinued at week 12 and subjects continued to receive Oracea or placebo through week 16. Measurements in the changes in the number of inflammatory lesions were taken at weeks 4, 8, 12 and 16. The primary endpoint was the mean number of changes at week 12 and 16. The mean number of inflammatory lesions at baseline was 21.3 for the Oracea + MetroGel group and 18.7 for the placebo + MetroGel group. Statistical significance was reached at week 12, with a mean reduction in inflammatory lesions compared to baseline of 13.9 and 8.5, respectively, for the two treatment groups (p=0.002). The mean percent in inflammatory lesions was 66.4% in the Oracea + MetroGel group compared to 48.2% in the placebo + MetroGel group (p=0.008). At week 16, after MetroGel had been discontinued, the subjects on Oracea alone maintained their improvement while those on placebo did not. The mean total reduction of inflammatory lesions compared to baseline for the Oracea group was 13.4, while those treated with placebo experienced a mean total reduction of 6.5 inflammatory lesions (p=0.0006). Oracea was approved by the FDA as a monotherapy treatment of rosacea in May of 2006. CollaGenex plans to investigate the possibility of FDA approval for the combination therapy.

August 8, 2005

CollaGenex issued positive results of a phase II trial of COL-3, for the treatment of rosacea, at the summer meeting of the North Carolina Dermatology Association. The drug met its primary efficacy endpoint, reducing mean lesion count at day 42 by 12.8 per patient, compared to a mean increase of 2.3 lesions per patient receiving placebo (p=0.0213). Furthermore onset of action was observed to be rapid, with 80% of the total endpoint reduction observed by day 14. 75% of patients receiving COL-3 achieved complete or near complete disappearance of symptoms, as measure by Investigators Global Assessment. Finally, incidence of erythema was slightly improved in the COL-3 group (2.5 point reduction in severity) compared to placebo (1.7 point reduction). This double-blinded, placebo- controlled proof-of-principle study enrolled 14 patients, who received 10 mg of the drug (n=8) or placebo (n=6) once daily for 42 days.

Cytochroma has issued positive results of a phase Ib trial of CTA018, their vitamin D analog and CYP24 inhibitor for the treatment of psoriasis. Trial data met their primary safety endpoint, with no serious adverse events reported and positive local and systemic adverse event profiles. Pharmacokinetic data did not indicate systemic exposure 48 hours post treatment in the highest dosing group. This multicenter, 4-arm, randomized, open-label, parallel- group comparison study enrolled 28 patients with plaque psoriasis; subjects received one of three dose concentrations of CTA018 (1, 3, or 10 mcg/g) or vehicle cream, applied to 5% of the body surface daily for 13 days, with a observational follow-up 7 days after treatment. Based on these results, the company announced plans to initiate a phase II trial of the drug in Q4 2005.

Isolagen announced positive results of a phase III trial of their autologous fibroblast transplant therapy, dubbed the Isolagen Process, for the treatment of dermal contour deformities. Results from the parallel-arm study met three of four primary endpoints, producing significant improvements in appearance of contour deformities on both patient and physician visual assessment scales in one arm, but only statistical improvement in patient assessment in the second arm. Significant efficacy variance was noted between investigative sites (range of improvement: 7.6%-73.3%), based primarily on differences in injection technique. This randomized, double blind, placebo-controlled parallel arm study enrolled two study cohorts of 100 patients each across 5 US sites. Based on these results, Isolagen announced that they planned to initiate an additional 100 patient study of the drug with expended training regarding injection technique. This additional trial delays the projected BLA filing date until 2006.

Isotechnika reported positive interim results of their phase III SPIRIT trial of ISA247 for the treatment of psoriasis. Blinded, combined data from all treatment groups from the first 12 weeks of the trial (n=369 patients) yielded a mean reduction in Psoriasis Area and Severity Index (PASI) score of 38%, indicating potential efficacy. The data also indicated a positive safety profile, with the highest variance in serum creatinine levels in any treatment group being 5.6%, a value considered within the normal physiogical range. Less than 2% of subjects in any dosing group withdrew from the study after 12 weeks due to changes in kidney function. This randomized, double-blind study enrolled 453 patients with severe plaque psoriasis across 32 sites in Canada. Subjects received one of 3 doses of ISA247 (0.2 mg/kg, 0.3 mg/kg and 0.4 mg/kg) or placebo twice daily, with subjects receiving placebo switching to the middle dosing regimen after the first 12 weeks of the 24 week study. Full 24 week data was expected during the first half of 2006.

August 1, 2005

CollaGenex has announced positive results of a pair of phase III trials of Oracea, for the treatment of rosacea, at the summer meeting of the American Academy of Dermatology. Both studies met their primary efficacy endpoint, with the drug producing a 61% and 46% reduction in Investigator's Global Assessment score in each trial respectively, compared to 29% and 20% for placebo (p<0.001). Further, the portion of subjects achieving a complete or near complete response was also significant in both trials compared to both baseline (p<0.001, p=0.004, respectively) and placebo (p=0.036, p=0.012). Secondary improvement in symptoms of erythema trended towards significance in one study, and achieved significance in the second (p= 0.017). These identical-design, concurrent, double- blind, placebo-controlled studies enrolled a combined 537 subjects across 28 sites in the US.

April 25, 2005

CollaGenex announced positive results of a phase II trial of COL-3, for the treatment of rosacea. At the end of the observation period (42 days), patients receiving COL-3 yielded a significant 69% reduction in lesion count, vs. 12% for placebo (p < 0.01). Furthermore, improvement was also seen in lesion count during interim observations, overall clinical severity score and incidence of erythema. This double-blind, placebo-controlled proof-of- principle study enrolled 13 rosacea patients across 3 US sites, who received COL-3 or placebo for 28 days. The company announced plans to initiate a second proof-of-principle study, in patients with acne, in the near future.

February 23, 2004

CollaGenex Pharmaceuticals reported positive results from a phase III trial investigating Periostat (doxycycline hyclate) for the treatment of rosacea. Preliminary results demonstrated that subjects treated with Periostat showed a continuous improvement during the 16-week study compared with placebo. Data showed that subjects given Periostat had a significantly greater reduction in the number of inflammatory lesions compared with placebo. The double-blinded, placebo-controlled study enrolled 134 subjects and was designed to test the safety and efficacy of Periostat (20mg BID). Full results will be presented at the Skin Disease Education Foundation's Phoenix Dermatology Open Seminar on March 21, 2004.

March 11, 2002

Positive results were reported from a phase II trial of topical alicaforsen (ISIS 2302) in subjects with mild to moderate plaque psoriasis. The double-masked trial, which included 31 subjects, compared 4% topical alicaforsen cream to placebo. Fifteen subjects in the trial applied treatment once per day, while 16 applied twice per day. Results showed that treatment with alicaforsen resulted in statistically significant improvement in Investigators Global Response Score (IGRS) at week four and a positive trend toward improvement at week eight. Furthermore, alicaforsen produced a 31% improvement from baseline in terms of plaque induration at both four and eight weeks. Alicaforsen is being developed by Isis Pharmaceuticals.

March 5, 2002

Data from a pooled analysis of two phase III trials indicates that Xanelim (efalizumab) produces an early clinical improvement in subjects with moderate-to-severe psoriasis. In the two trials, 1,095 subjects received weekly subcutaneous doses of 1 mg/kg Xanelim, 2 mg/kg Xanelim or placebo. At 12 weeks, mean PASI score improvements were 14% for the 1 mg/kg Xanelim group and 13% for the 2 mg/kg group, compared to 8% for placebo-treated subjects. Furthermore, after 12 weeks, 29% of subjects treated with 1 mg/kg Xanelim and 28% of those treated with 2 mg/kg achieved PASI score improvement of 75% or greater, versus 3.4% of those receiving placebo. Xanelim is being developed by Genentech and Xoma.

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