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Spotswood L Spruance - One of the best experts on this subject based on the ideXlab platform.
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Topical Iontophoretic Administration of Acyclovir for the Episodic Treatment of Herpes Labialis: A Randomized, Double-Blind, Placebo-Controlled,
2016Co-Authors: Clinic-initiated Trial, Spotswood L Spruance, Eric M. Morrel, Dennis I. Goldberg, The Iontophoretic Acyclovir Cold SoreAbstract:Background. Multiple studies of the use of acyclovir for the treatment of Herpes Labialis have suggested that the nominal efficacy of the topical formulation is the result of inadequate penetration of the drug into the target site of infection, the basal epidermis. Methods. We developed a low-voltage, wireless, handheld, computer-controlled, iontophoretic applicator to enhance the skin penetration of topical acyclovir in the treatment of Herpes Labialis. We performed a multicenter, placebo-controlled, clinic-initiated, pilot trial of a single, topical, iontophoretic application of 5 % acyclovir cream for the episodic treatment of Herpes Labialis among 200 patients with an incipient cold sore outbreak at the erythema or papular/edema lesion stage. Results. The median classic lesion healing time (aborted lesions were assigned a value of 0 h) was 1.5 days shorter for the active treatment group than for the vehicle group (113 h vs. 148 h;). In the subgroup ofPp.02 patients who presented with lesions in the erythema stage, the median classic lesion healing time was 3 days shorter for the acyclovir group, compared with the control group (49 h vs. 120 h;), and the acyclovir group tendedP!.03 to have more aborted lesions than did the control group (46 % vs. 24%;).Pp.10 Conclusions. Single-dose topical iontophoresis of acyclovir appears to be a convenient and effective treatment for cold sores and merits further clinical investigation
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Combination treatment with famciclovir and a topical corticosteroid gel versus famciclovir alone for experimental ultraviolet radiation-induced Herpes simplex Labialis: a pilot study. J Infect Dis. 2000;181(6):1906–10. Available at: http://www.ncbi.nlm.ni
2013Co-Authors: Spotswood L Spruance, School Of MedicineAbstract:To investigate the ef®cacy of corticosteroids for the treatment of Herpes Labialis, we com-pared famciclovir (Famvir, 500 mg 33/day po [per os] for 5 days) and topical ¯uocinonide (0.05 % Lidex Gel 33/day for 5 days) with famciclovir and topical vehicle control for experi-mental ultraviolet radiation±induced herpetic recurrences. We irradiated 49 volunteers, and 29 (60%) of 48 developed signs or symptoms of a recurrence. They self-initiated treatment, and we were able to evaluate them. There was a trend in the combination group toward more aborted lesions, compared with those who received antiviral therapy alone (7 [41%] of 17 vs. 1 [8%] of 12;). Combination therapy signi®cantly reduced the median maximum lesionP =.09 size (48 vs. 162 mm2; ) and the number of patients who experienced lesion pain (10P =.02 [59%] of 17 vs. 12 [100%] of 12;). Adverse events were minimal. Corticosteroids inP =.02 combination with an antiviral agent may be safe and bene®cial for episodic treatment of Herpes Labialis. Larger studies are needed to con®rm these ®ndings. Treating Herpes Labialis with antiviral drugs has been a major challenge for investigators over the past 3 decades [1, 2], and the treatment bene®ts to date have been modest [3±6]. Othe
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Acyclovir and hydrocortisone cream for the early treatment of recurrent cold sores
Dove Medical Press, 2011Co-Authors: Carrie A Sailer, Spotswood L Spruance, Christopher M HullAbstract:Carrie A Sailer1, Spotswood L Spruance2, Christopher M Hull11Department of Dermatology, 2Department of Medicine, Division of Infectious Diseases, University of Utah, Salt Lake City, USAAbstract: Current antiviral therapies for Herpes simplex Labialis primarily reduce healing time. Since the host immune response also plays a role in both controlling recurrent infection as well as producing clinical symptoms, new studies are showing efficacy using topical corticosteroids. This review will evaluate the safety and efficacy of 5% acyclovir–1% hydrocortisone cream (Xerese™[US], Xerclear®[Europe]) for treatment of patients with Herpes simplex Labialis. A large, randomized, double-blind, placebo-controlled study recently demonstrated that treatment with 5% acyclovir–1% hydrocortisone cream significantly decreased the percentage of ulcerative lesions, reduced lesion healing time, and decreased mean lesion area compared with both topical acyclovir alone and vehicle.Keywords: Herpes Labialis, Herpes simplex virus, HSV, acyclovir, hydrocortisone, ME-609, Xerese, Xerclea
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single dose patient initiated famciclovir a randomized double blind placebo controlled trial for episodic treatment of Herpes Labialis
Journal of The American Academy of Dermatology, 2006Co-Authors: Spotswood L Spruance, Neil Bodsworth, Harvey Resnick, Claude Oeuvray, Marcus A Conant, Kamal HamedAbstract:Background The brief period of viral replication in recurrent Herpes Labialis lesions suggests shorter therapeutic regimens are a logical episodic treatment strategy. Objective We sought to assess the efficacy and safety of single-dose and single-day famciclovir treatments. Methods In all, 701 randomly assigned patients self-initiated therapy with famciclovir (1500 mg once [single dose] or 750 mg twice a day for 1 day [single day]) or placebo within 1 hour of onset of the prodromal symptoms of an episode of Herpes Labialis. Lesion healing was monitored by diaries and frequent clinic visits. Results Median healing times of primary (first to appear) vesicular lesions in the famciclovir single-dose, famciclovir single-day, and placebo groups were 4.4, 4.0, and 6.2 days, respectively. There was no significant difference between the famciclovir regimens. Adverse events in the famciclovir groups were similar to placebo. Limitations The active arms of this trial were not directly compared to other antiviral regimens. Conclusion Single-dose famciclovir reduced time to healing of Herpes Labialis lesions by approximately 2 days compared with placebo.
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acyclovir cream for treatment of Herpes simplex Labialis results of two randomized double blind vehicle controlled multicenter clinical trials
Antimicrobial Agents and Chemotherapy, 2002Co-Authors: Spotswood L Spruance, Robert Nett, T Marbury, Ray Wolff, James Johnson, Theodore SpauldingAbstract:Acyclovir cream has been available for the treatment of Herpes Labialis in numerous countries outside the United States for over a decade. Evidence for its efficacy comes from a few small clinical trials conducted in the 1980s. To examine more comprehensively the efficacy and safety of this formulation, we conducted two independent, identical, parallel, randomized, double-blind, vehicle-controlled, large-scale multicenter clinical trials. Healthy adults with a history of frequent Herpes Labialis were recruited from the general population, screened for eligibility, randomized equally to 5% acyclovir cream or vehicle control, given study medication, and told to self-initiate treatment five times daily for 4 days beginning within 1 h of the onset of a recurrent episode. The number of patients who treated a lesion was 686 in study 1 and 699 in study 2. In study 1, the mean duration of episodes was 4.3 days for patients treated with acyclovir cream and 4.8 days for those treated with the vehicle control (hazards ratio [HR] = 1.23; 95% confidence interval [CI], 1.06 to 1.44; P = 0.007). In study 2, the mean duration of episodes was 4.6 days for patients treated with acyclovir cream and 5.2 days for those treated with the vehicle control (HR = 1.24; 95% CI, 1.06 to 1.44; P = 0.006). Efficacy was apparent whether therapy was initiated “early” (prodrome or erythema lesion stage) or “late” (papule or vesicle stage). There was a statistically significant reduction in the duration of lesion pain in both studies. Acyclovir cream did not prevent the development of classical lesions (progression to vesicles, ulcers, and/or crusts). Adverse events were mild and infrequent.
Mark B Mckeough - One of the best experts on this subject based on the ideXlab platform.
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comparison of new topical treatments for Herpes Labialis efficacy of penciclovir cream acyclovir cream and n docosanol cream against experimental cutaneous Herpes simplex virus type 1 infection
Archives of Dermatology, 2001Co-Authors: Mark B Mckeough, Spotswood L SpruanceAbstract:Background: There are 3 new topical treatments for Herpes Labialis that have either been approved by the US Food and Drug Administration (penciclovir cream [Denavir] and n-docosanol cream [Abreva]) or recently undergone extensive clinical evaluation (acyclovir cream). The relative efficacy of these products is unknown. Objective: To compare the efficacy of penciclovir cream, acyclovir cream, n-docosanol cream, and acyclovir ointment in an experimental animal model of cutaneous Herpes simplex virus type 1 (HSV-1) disease. Design: The backs of guinea pigs were infected with HSV-1 using a vaccination instrument. Active treatments and corresponding vehicle controls were applied for 3 to 5 days beginning 24 hours after inoculation. Main Outcome Measures: After completion of treatment, the animals were killed and the severity of the infection assessed from the number of lesions, the total lesion area, and the lesion virus titer. Results: Penciclovir cream effected modest reductions in lesion number (19%), area (38%), and virus titer (88%) compared with its vehicle control, and each of these differences was significantly greater (P,.05) than the reductions effected by acyclovir ointment (0%, 21%, and 75%, respectively). The acyclovir cream effect (reductions of 4%, 28%, and 77%, respectively) was less than that of penciclovir cream, and this difference was confirmed by 2 additional head-to-head experiments. Two experiments with n-docosanol cream failed to show statistically significant differences by any parameter between n-docasonol cream and vehicle control‐treated sites or between n-docosanol and untreated infection sites. Conclusions: In this model, the efficacy of penciclovir cream was greater than acyclovir cream, acyclovir cream was greater than or equal to acyclovir ointment, and acyclovir ointment was greater than n-docosanol cream. Since our model was designed to evaluate compounds that function primarily through antiviral activity, the negative findings with n-docosanol in these studies do not exclude that it might work clinically through other mechanisms.
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combination treatment with famciclovir and a topical corticosteroid gel versus famciclovir alone for experimental ultraviolet radiation induced Herpes simplex Labialis a pilot study
The Journal of Infectious Diseases, 2000Co-Authors: Spotswood L Spruance, Mark B MckeoughAbstract:To investigate the efficacy of corticosteroids for the treatment of Herpes Labialis, we compared famciclovir (Famvir, 500 mg 33/day po [per os] for 5 days) and topical fluocinonide (0.05% Lidex Gel 33/day for 5 days) with famciclovir and topical vehicle control for experimental ultraviolet radiation‐induced herpetic recurrences. We irradiated 49 volunteers, and 29 (60%) of 48 developed signs or symptoms of a recurrence. They self-initiated treatment, and we were able to evaluate them. There was a trend in the combination group toward more aborted lesions, compared with those who received antiviral therapy alone (7 [41%] of 17 vs. 1 [8%] of 12; ). Combination therapy significantly reduced the median maximum lesion P= .09 size (48 vs. 162 mm 2 ; ) and the number of patients who experienced lesion pain (10 P= .02 [59%] of 17 vs. 12 [100%] of 12; ). Adverse events were minimal. Corticosteroids in P= .02 combination with an antiviral agent may be safe and beneficial for episodic treatment of Herpes Labialis. Larger studies are needed to confirm these findings.
David I Bernstein - One of the best experts on this subject based on the ideXlab platform.
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Glycoprotein D adjuvant Herpes simplex virus vaccine.
Expert review of vaccines, 2005Co-Authors: David I BernsteinAbstract:Herpes simplex virus (HSV) Type-1 and -2 are common infections that can cause primary and recurrent Herpes Labialis and genitalis, as well as gingivostomatitis, keratoconjunctivitis, encephalitis, disseminated infections in immunocompromised persons and neonatal infections. Despite several decades of HSV vaccine development, no effective vaccine has been developed until recently. The following review of the genital HSV-2 glycoprotein D (gD2t, t is for truncated) subunit vaccine formulated with a new adjuvant (AS04) containing alum and 3-O deacylated monophosphoryl lipid A (MPL) provides a background in which to evaluate the vaccine as well as a brief review of other approaches to Herpes vaccines. The gD2t-AS04 vaccine has been demonstrated to be safe in several large clinical trials. In two trials, the vaccine reduced genital Herpes disease by 73 and 74%, but only in females with no previous HSV infection. A large ongoing trial in HSV seronegative females will provide additional data on protection from HS...
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peroral famciclovir in the treatment of experimental ultraviolet radiation induced Herpes simplex Labialis a double blind dose ranging placebo controlled multicenter trial
The Journal of Infectious Diseases, 1999Co-Authors: Spotswood L Spruance, Nathaniel H Rowe, Wayne G Raborn, Edward A Thibodeau, Joseph A Dambrosio, David I BernsteinAbstract:Three doses of famciclovir were tested for treatment of experimental ultraviolet radiation (UVR)-induced Herpes Labialis. Patients received 125, 250, or 500 mg of famciclovir or placebo 3 times a day for 5 days beginning 48 h after UVR exposure, a model of early episodic intervention. Of 248 patients irradiated, 102 developed lesions while on treatment. There were no significant differences between groups in the number of lesions. The mean maximal lesion size was reduced in a dose-proportional manner: 139, 105, 77, and 55 mm 2 for the placebo and 125-, 250-, and 500-mg famciclovir groups, respectively (P = .040, linear regression). Median time to healing was faster in the 500-mg famciclovir group than in the placebo group, both by investigator (4 vs. 6 days, 33% reduction, P = .010) and patient assessment (3.0 vs. 5.8 days, 48% reduction, P = .008) analyses. These findings suggest that evaluation of higher drug doses for Herpes Labialis treatment is warranted.
Bertram Ottillinger - One of the best experts on this subject based on the ideXlab platform.
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Comparative Study with a Lip Balm Containing 0.5% Propolis Special Extract GH 2002 versus 5% Aciclovir Cream in Patients with Herpes Labialis in the Papular/Erythematous Stage: A Single-blind, Randomized, Two-arm Study.
Current Therapeutic Research-clinical and Experimental, 2017Co-Authors: Petr Arenberger, Simona Holcová, Marie Hladiková, Monika Arenbergerova, Bertram OttillingerAbstract:Abstract Background and objectives This controlled single-blind trial compared the efficacy of a lip balm with propolis special extract GH 2002 at a concentration of 0.5% in the treatment of episodes of Herpes Labialis with that of 5% aciclovir cream. Methods Patients in the erythematous/papular stage were randomized: 189 patients were treated with propolis cream, 190 patients were treated with aciclovir cream (intention-to-treat population). Application was 5 times daily. The primary parameter was the difference in median time to complete encrustation or epithelialization of lesions. Secondary parameters were the development of typical Herpes symptoms (eg, pain, burning and itching, tension, and swelling), the global assessment of efficacy, and the safety of application. Results The predefined clinical situation was reached after a median of 4 days with propolis and after 5 days with aciclovir ( P Conclusions A formulation of 0.5% propolis GH 2002 extract lip balm was found to be superior in the treatment of episodes of Herpes Labialis over 5% aciclovir cream in patients in the papular/erythematous phase upon inclusion. EudraCT Registration No. 2006-001971-38.
David W Osborne - One of the best experts on this subject based on the ideXlab platform.
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a double blind placebo controlled study of topical tetracaine in the treatment of Herpes Labialis
Journal of The American Academy of Dermatology, 1999Co-Authors: Lewis H Kaminester, Robert J Pariser, David M Pariser, Jonathan Weiss, Joel S Shavin, Larry Landsman, Harold G Haines, David W OsborneAbstract:Abstract Background: Before the September 1996 approval of 1% penciclovir cream for the treatment of Herpes Labialis, no other prescription topical therapy was approved for the treatment of this recurrent viral disease affecting approximately 20% of the adult population of the United States. Local anesthetics, such as tetracaine, have been used in over-the-counter topical products, but are only labeled for the relief of pain and itching associated with cold sores and fever blisters. Objective: The purpose of this study was to determine whether a topical preparation of a tetracaine cream is safe and effective in the treatment of recurrent Herpes Labialis in immunocompetent patients. Methods: A double-blind, placebo-controlled study was conducted to assess the relative effectiveness and safety of 1.8% tetracaine equivalent in a cream base versus placebo in the treatment of Herpes Labialis in immunocompetent adults. In this study, patients applied medication up to 6 times daily until the lesions healed (scab loss), but for no more than 12 days. The patients were monitored on the day of enrollment, once during the course of treatment, and at a final visit after the lesions had healed. Patients assessed themselves the day of scab formation and the day the scab fell off. They also graded, on a daily basis, their perception of relief from itching and pain and the overall benefit. Results: The results from 72 patients (35 = placebo; 37=active) showed that scab formation occurred in a mean of 2.4 ± 0.27 days for the placebo group and 2.3 ± 0.26 days for the active group. Healing time (scab loss) occurred in a mean 7.2 ± 0.36 days for the placebo group and in 5.1 ± 0.35 days in the active group. The difference observed for healing time between the placebo and the active tetracaine cream was statistically significant (P = .0002). This represents an approximately 30% reduction in the healing time for the active group compared with the placebo group. In addition, the study patients ranked the benefit of their treatment on a daily basis and graded the overall benefit of the therapy at their final visit. The ranking was on a 1 to 10 index scale (1 = no benefit at all; 10=very effective treatment). At the final visit there was a statistically significant difference in the benefit index for active preparation versus placebo for this subjective evaluation (placebo index, 5.9 ± 0.6; active index, 7.3 ± 0.48 [P = .0359]). The subjects also evaluated relief from itching and pain on a daily basis. Relief from itching was significantly greater in the active group than in the placebo group on days 2 and 3 after initiation of the treatment. Pain was not found to be severe in either the placebo or active treatment groups. At day 2 of treatment and beyond, pain scores never were greater than 3.2 ± 0.28 for active on a scale in which 1.0 represented "no pain at all" and 10 represented "most severe pain imaginable." Although mean values for pain were always less for the active therapy, lesional pain scores never reached statistically significant lower values for active compared with placebo. Conclusion: Our findings indicate that a 1.8% topical tetracaine cream, when applied frequently, significantly reduces the healing time of recurrent Herpes Labialis lesions. Additionally, it is perceived by the study subjects to reduce itching of the lesions and to have a beneficial overall effect. (J Am Acad Dermatol 1999;41:996-1001.)