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• W3015326677 abstract "To the Editor: Herpes labialis is a common condition with painful blisters or sores around the lips, and there are limited choices to prevent or reduce the severity of outbreaks.1Sarnoff D.S. Treatment of recurrent herpes labialis.J Drugs Dermatol. 2014; 13: 1016-1018PubMed Google Scholar It is caused by herpes simplex virus type 1 (HSV-1) and, less commonly, type 2 (HSV-2). Squaric acid dibutyl ester (SADBE) is a topical immunosensitizer to treat verruca vulgaris and alopecia areata.2Palli M.A. McTavish H. Kimball A. Horn T.D. Immunotherapy of recurrent herpes labialis with squaric acid.JAMA Dermatol. 2017; 153: 828-829Crossref PubMed Scopus (5) Google Scholar,3Lee A.N. Mallory S.B. Contact immunotherapy with squaric acid dibutylester for the treatment of recalcitrant warts.J Am Acad Dermatol. 1999; 41: 595-599Abstract Full Text PDF PubMed Scopus (58) Google Scholar Previously, a single topical dose of 2% SADBE dissolved in dimethyl sulfoxide (DMSO) applied to the arm skin significantly extended the time to the next outbreak.4Rokhsar C.K. Shupack J.L. Vafai J.J. Washenik K. Efficacy of topical sensitizers in the treatment of alopecia areata.J Am Acad Dermatol. 1998; 39: 751-761Abstract Full Text Full Text PDF PubMed Scopus (126) Google Scholar In a separate study, a single topical dose of 2% SADBE in DMSO on the arm in patients with frequent outbreaks significantly improved immune response to HSV-1 in vitro 8 weeks later, with a significant increase in interferon gamma expression.5McTavish H. Zerebiec K.W. Zeller J.C. Shekels L.L. Matson M.A. Kren B.T. Immune characteristics correlating with HSV-1 immune control and effect of squaric acid dibutyl ester on immune characteristics of subjects with frequent herpes labialis episodes.Immun Inflamm Dis. 2019; 7: 22-40Crossref PubMed Scopus (2) Google Scholar In this study, we explored whether a regimen with a second dose of topical 0.5% SADBE to the upper arm skin might be superior to a single dose of 2% SADBE to reduce the frequency or severity of herpes labialis. After institutional review board approval and written informed consent, this study was conducted at 5 centers with patients with 4 or more herpes labialis episodes in the previous 12 months. Participants were randomly assigned to receive either (1) 1 dose of 2% SADBE on day 1, (2) 2% SADBE on day 1 and a second lower-dose (0.5%) booster on day 22, or (3) DMSO vehicle only on days 1 and 22. All participants were followed for 1 year. Eligible individuals (N = 140) enrolled with a median number of outbreaks of 6 (mean, 7.8) in the prior 12 months. The 1-dose group had superior results versus the placebo group in time to next outbreak from day 43 to 121 (P = .024) (Fig 1), mean number of outbreaks in days 43 through 121 (0.231 ± 0.125 standard error in the 1-dose group vs 0.610 ± 0.068 in the placebo group; P = .011), and proportion of participants with an outbreak in days 43 through 121 (9/39 [23%] in the 1-dose group vs 19/41 [46%] in the placebo group; P = .036). The average number of moderate or severe outbreaks over days 43 through 121 was also reduced in patients receiving 1 dose of SADBE (0.128 ± 0.339) versus placebo (0.390 ± 0.703) (P = .04), as well as over days 1 through 365 in the 1-dose (0.641 ± 0.931) versus placebo group (1.341 ± 1.76) (P = .04). Notably, the 2-dose group had superior results compared with the placebo group on these same measures, but not significantly so. Why the 1-dose may be superior to the 2-dose regimen remains to be investigated, but we hypothesize that the second dose at lower concentration may tolerize or downregulate the immune changes from the 2% SADBE in the first dose. The largest improvements observed in the SADBE-treated groups occurred within days 43 through 121 of the study. One possible reason may be that SADBE takes about 6 weeks to exert maximal effect on the immune system, and the effects begin to taper off at approximately 3 to 4 months after the first dose. The most common adverse event type was administration site reactions, which all were mild or moderate, and all resolved within 3 months (Table I), suggesting a favorable risk-benefit profile for topical 2% SADBE in high-frequency herpes labialis.Table IAdverse events scored by investigators as definitely, probably, or possibly study-medication relatedAdverse event∗All adverse events were grade 1 (n = 49) or grade 2 (n = 6), with no grade 3 or higher adverse events.Placebo, n (47 participants)SADBE: 1 or 2 doses, n (92 participants)Administration site conditions Erythema415 Itching or irritation18 Tingling or stinging40 Purpura01 Boil01 Subtotal925Tingling (not at administration site)32Flushing and burning sensation on face03Herpes lesion on genitals, anus, or spine12Dermatitis from bandage adhesive20Irritation or itching (not at administration site)02Rash (not at administration site)01Retention hyperkeratosis01Lightheadedness10Pimple01Papule on lip01Anemia10Total1738SADBE, Squaric acid dibutyl ester.∗ All adverse events were grade 1 (n = 49) or grade 2 (n = 6), with no grade 3 or higher adverse events. Open table in a new tab SADBE, Squaric acid dibutyl ester." @default.
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• W3015326677 title "A phase 2, multicenter, placebo-controlled study of single-dose squaric acid dibutyl ester to reduce frequency of outbreaks in patients with recurrent herpes labialis" @default.
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