Double-Blind, Randomized, Placebo-Controlled Pilot Study of the Safety and Efficacy of Myobloc (Botulinum Toxin Type B) for the Treatment of Palmar Hyperhidrosis

BACKGROUND: Palmar hyperhidrosis is a problem of unknown etiology that affects patients both socially and professionally. Botulinum toxin type B (Myobloc), approved by the Food and Drug Administration for use in the treatment of cervical dystonia in the United States in December 2000, has subsequently been used effectively in an off-label indication to treat hyperhidrosis. There are sparse data, however, in the literature evaluating the safety and efficacy of BTX-B for the treatment of palmar hyperhidrosis. OBJECTIVE: We evaluated the safety and efficacy of Myobloc in the treatment of bilateral palmar hyperhidrosis. This was a double-blind, randomized, placebo-controlled study to report on the safety and efficacy of Myobloc. METHODS: Twenty participants (10 men, 10 women) diagnosed with palmar hyperhidrosis were injected with either Myobloc (5,000 U per palm) or a 1.0 mL vehicle (100 mM NaCl, 10 mM succinate, and 0.5 mg/mL human albumin) into bilateral palms (15 Myobloc, 5 placebo). The participants were followed until sweating returned to baseline levels. The main outcome measures were safety, efficacy versus placebo, and duration of effect. RESULTS: A significant difference was found in treatment response at day 30, as determined by participant assessments, between 15 participants injected with Myobloc and 3 participants injected with placebo. The duration of action, calculated in the 17 participants who received Myobloc injections and completed the study, ranged from 2.3 to 4.9 months, with a mean duration of 3.8 months. The single most reported adverse event was dry mouth or throat, which was reported by 18 of 20 participants. The adverse event profile also included indigestion or heartburn (60%), excessively dry hands (60%), muscle weakness (60%), and decreased grip strength (50%). CONCLUSION: Myobloc proved to be efficacious for the treatment of palmar hyperhidrosis. Myobloc had a rapid onset, with most participants responding within 1 week. The duration of action ranged from 2.3 to 4.9 months, with a mean of 3.8 months. The adverse event profile included dry mouth, indigestion or heartburn, excessively dry hands, muscle weakness, and decreased grip strength.     

Double-Blind, Randomized, Placebo-Controlled, Dose-Response Study of the Safety and Efficacy of Botulinum Toxin Type A in Subjects with Crow''s Feet

BACKGROUND: Published evidence suggests that botulinum toxin type A (BTX-A) is an effective treatment for crow's feet. However, few dose-ranging studies have been performed. OBJECTIVES: To assess the safety and efficacy of a single treatment with one of four doses of BTX-A (Botox/Vistabel, Allergan Inc) compared with placebo for the improvement of crow's feet. METHODS: Subjects received a single bilateral treatment of 18, 12, 6, or 3 U of BTX-A or placebo injected into the lateral aspect of the orbicularis oculi muscle (parallel-group, double-blind design). Investigators and subjects rated crow's feet severity at maximum smile on day 7 and at 30-day intervals from days 30 to 180. RESULTS: As observed by both investigators and subjects, all doses of BTX-A resulted in improvements in crow's feet severity when compared with placebo. A dose-dependent treatment effect for efficacy was observed, with higher doses having an increased magnitude and duration of effect. However, a clear differentiation between the 18 U and 12 U doses was not apparent. Few adverse events were reported, with no statistically significant differences between BTX-A and placebo in the incidence of subjects experiencing adverse events. CONCLUSION: BTX-A is safe and effective in decreasing the severity of crow's feet, with 12 U per side suggested as the most appropriate dose.     

Botulinum Toxin Type B (Myobloc)

Myobloc, known as Neurobloc in Europe, is a member of the botulinum toxin family. It has been used for a myriad of problems since its approval in the United States in December 2000. It is currently not approved for cosmetic use but has been used for this purpose. This article reviews what is currently known about botulinum toxin type B and its efficacy and safety.     

Efficacy and Safety of Botulinum Toxin Type A in the Treatment of Palmar Hyperhidrosis: A Double-Blind, Randomized, Placebo-Controlled Study

BACKGROUND: Recent studies demonstrate that botulinum toxin type A (BTX-A) decreases palmar hyperhidrosis. OBJECTIVE: To evaluate the efficacy and safety of BTX-A for palmar hyperhidrosis. METHODS: Patients (n = 19) received injections of placebo (normal saline) in one hand and BTX-A in the other. Assessments included gravimetric measurement of sweat production and physician's and patient's rating of severity. Safety evaluations included measuring grip strength. Preliminary 28-day results are reported. RESULTS: The mean percentage decrease in gravimetric measurement at day 28 was significantly greater with BTX-A versus placebo. One hundred percent of 17 patients rated the treatment as successful, while only 12% (2/17) rated placebo injection successful. Grip and hand strength were unchanged with either treatment. Only 21% (4/19) reported mild adverse events. CONCLUSION: BTX-A injections produce significant improvements in palmar hyperhidrosis without a concomitant decrease in grip or dexterity, or the occurrence of serious adverse events.     

Patient-Reported Outcomes with Botulinum Toxin Type A Treatment of Glabellar Rhytids: A Double-Blind, Randomized, Placebo-Controlled Study

BACKGROUND Global patient-reported outcomes do not evaluate specific aspects of treatment that are important to patients.
OBJECTIVE The objective was to evaluate self-perception of age and specific outcomes that are important to patients receiving botulinum toxin type A or placebo for moderate to severe glabellar lines (using the Facial Line Outcomes Questionnaire to assess how much facial lines bother them, make them look older, detract from their facial appearance, prevent a smooth facial appearance, and make them look tired, stressed, or angry).
METHODS AND MATERIALS In the double-blind phase of this 12-week study, 70 patients were randomly assigned to treatment with 20 U botulinum toxin type A (BOTOX Cosmetic) or placebo. At Week 4, those still with moderate or severe glabellar lines were offered open-label 20 U botulinum toxin type A.
RESULTS Median glabellar line severity was significantly lower after botulinum toxin treatment than after placebo. Compared with placebo, botulinum toxin also resulted in significantly superior patient assessments and a greater proportion of patients considering they looked younger than their current age.
CONCLUSIONS Botulinum toxin type A can achieve specific goals of treatment that are important to patients and help them feel that they look younger than their current age.     

A Randomized, Double-Blind, Placebo-Controlled Study of Botulinum Toxin Type A for the Treatment of Glabellar Lines: Determination of Optimal Dose

BACKGROUND Botulinum toxin is used to treat glabellar lines, but the optimal dose of Reloxin (Dysport, Ipsen Biopharm Ltd.) for this indication remains to be established.
OBJECTIVE The objective was to evaluate three doses of Reloxin to determine its efficacy and safety in treating glabellar lines.
METHODS AND MATERIALS Participants were given 20, 50, or 75 U of Reloxin, or placebo, injected across the glabella. Follow-up was on Days 7, 30, 60, 90, and 120. Adverse events were also elicited by telephone on Day 3.
RESULTS From investigators' and participants' assessments at Day 30, there were significantly more responders in each Reloxin-treated group than placebo ( p≤ 0.001). The 50-U dose was as effective as the 75-U dose, with a similar duration. The most common adverse events were mild headache and nasopharyngitis, occurring similarly in all groups.
CONCLUSIONS Reloxin (Dysport/botulinum toxin type A) treatment resulted in a significant improvement in glabellar lines, and the 50-U dose was identified as optimal. All doses were well tolerated.     

Prospective Open-Label Study of Botulinum Toxin Type B (Myobloc) at Doses of 2,400 and 3,000 U for the Treatment of Glabellar Wrinkles

BACKGROUND: A previous open-label study evaluated botulinum toxin type B (BTX-B; Myobloc) for the treatment of glabellar wrinkles and showed that it is safe and effective at a dose of 1,800 U. The duration of effect at this dose was approximately 8 weeks, and it was felt that higher doses would result in a longer duration of effect. OBJECTIVE: This is a prospective open-label study to assess the safety, efficacy, and duration of response following BTX-B injection at doses of 2,400 and 3,000 U for the treatment of glabellar frown lines. METHODS: A total of 39 patients were enrolled: 16 patients received 2,400 U. Eighteen patients received 3,000 U, and 5 patients received saline injections (control group). Doses were divided equally among six sites. RESULTS: All subjects had rapid improvement of interglabellar rhytides, with full response seen within 2 to 3 days. The duration of effect was 9.6 and 10.4 weeks with 2,400 and 3,000 U, respectively. Five subjects (two in the 2,400-U group and three in 3,000-U group) reported adverse events related to the BTX-B injection. Three subjects complained of mild pain at the injection site, and two subjects complained about lid droop/ptosis (one with the occurrence of headache). CONCLUSIONS: BTX-B injection is safe and effective for the treatment of glabellar wrinkles. It has a very rapid onset of action, and increasing the dose appears to prolong the duration of response. At 3,000 U, the duration of response was 10.4 weeks and was associated with minimal adverse effects. Adverse events were mild and were similar to those seen in previous studies with BTX-A. Additional studies evaluating BTX-B at higher doses are recommended to prolong the duration of response in the treatment of glabellar wrinkles.     

UV-B Irradiation Attenuates Dermal Effects of Botulinum Toxin A: A Randomized, Double-Blind, Placebo-Controlled Study

BACKGROUND Botulinum toxin type A (BoNT/A) is frequently used for cosmetic indications and hyperhidrosis.
OBJECTIVES We investigated whether UV-B irradiation alleviates the BoNT/A effect on local sudomotor activity.
MATERIALS AND METHODS In a randomized, double-blinded trial, the anhidrotic areas after BoNT/A (100 mU) injection 48 hours before and 14 days after UV-B irradiation were compared in six healthy volunteers.
RESULTS UV-B irradiation alleviated BoNT/A effect by approximately 30% ( p =.0017). The UV-B–evoked reduction of anhidrotic areas was constant over the observation period of 14 weeks.
CONCLUSIONS When BoNT/A is applied intradermally, excessive exposure to UV-B and sunburn should be reconsidered.     

A Comparison of Two Botulinum Type A Toxin Preparations for the Treatment of Glabellar Lines: Double-Blind, Randomized, Pilot Study

BACKGROUND: Botulinum toxins have been proven effective for reducing facial lines. There are two commercial types of botulinum toxin type A available in many countries but no published comparison studies. OBJECTIVE: To compare the efficacy and tolerability of Botox Cosmetic and Dysport 50 U in the treatment of glabellar lines (using 20 U of Botox Cosmetic, which is the dose approved by the US Food and Drug Administration for the treatment of glabellar lines, and 50 U of Dysport, which has been reported to be the optimal dose for this formulation). STUDY DESIGN: Parallel-group double-blind pilot study. Evaluation by observing physician, photographic, and patient evaluations. CONCLUSION: Botox 20 U provided better and more prolonged efficacy than Dysport 50 U in the treatment of glabellar lines.     

The Effect of Full-Face Broadband Light Treatments Alone and in Combination With Bilateral Crow''s Feet Botulinum Toxin Type A Chemodenervation

BACKGROUND: Broadband light (BBL; Intense Pulsed Light; Lumenis Ltd., Yokneam, Israel) is a powerful, nonablative, light-based technology that targets melanin and hemoglobin and stimulates the formation of collagen and elastin. Botulinum toxin type A (BTX-A; BOTOX; Allergan Inc., Irvine, CA) treatment of the lateral periocular region relaxes the vertical fibers of the orbicularis oculi and results in softening of the lateral orbital crow's feet rhytides and widening of the palpebral aperture. OBJECTIVE: To compare the effects of full-face BBL in combination with BTX-A and BBL alone in female subjects with Fitzpatrick I-III skin types, Glogau II-III rhytides, and significant associated facial lentigines and telangiectasia. METHODS: This was a prospective, randomized study of 30 women with moderate to severe crow's feet rhytides. Half of the subjects were treated with BTX-A and BBL and the other half with BBL alone. Their response was assessed clinically and photographically. Skin biopsies of the temporal skin were taken from two subjects in each group and were stained with Masson trichrome. RESULTS: Patients treated with a combination of BTX-A and BBL experienced a better response to treatment, both at rest and on maximum smile, as well as a slightly improved response in associated lentigines, telangiectasia, pore size, and facial skin texture compared with patients who received BBL treatment alone. Skin biopsies showed an increase in dermal collagen in each group. CONCLUSIONS: The patients in this study benefited from both treatments. Although BBL led to a remarkable improvement in full-face telangiectasias, lentigines, and skin texture, the improvement increased in all categories with combination therapy. In addition, an added improvement in the full-face aesthetic with both BTX-A and BBL therapy combined was obvious. These results suggest that both treatments--although evidently complementary--may also act synergistically to produce optimal clinical effects, revolutionizing the treatment of facial aging.     

A Randomized Pilot Study Comparing the Action Halos of Two Commercial Preparations of Botulinum Toxin Type A

BACKGROUND The determination of the action halos of botulinum toxin type A aids in targeting specific muscles and/or sweat glands, thereby preventing the occurrence of side effects.
OBJECTIVES The objective of this study was to compare the action halos of two commercial preparations of botulinum toxin type A, Dysport (Ipsen, Slough, UK) and BOTOX (Allergan, Irvine, CA).
MATERIAL AND METHODS Eighteen volunteers received applications of both products into randomized sides of the frontalis muscle. Equivalent doses of 5U of Dysport and 2U of BOTOX were injected using the same technique, in the same volume (0.02mL), and at a controlled depth. Twenty-eight days later, clinical and photographic assessments were performed.
RESULTS All the areas around the injected points were regular, round, or slightly oval and showed similar effects in the muscles and sweat glands. No statistically significant differences were observed between the mean sizes of the diameters of the halos produced by the two products.
CONCLUSION Injections of Dysport and BOTOX at an equivalence ratio of 2.5:1U, respectively, applied at the same volume and depth, using the same technique resulted in similar action halos with regard to muscular and sweat gland activity. Both products seem to be safe and very predictable.     

Botulinum Toxin Type B (MYOBLOC) Versus Botulinum Toxin Type A (BOTOX) Frontalis Study: Rate of Onset and Radius of Diffusion

BACKGROUND: Botulinum toxin types A and B can improve the appearance of facial wrinkles. Differences in the time until onset and the degree of diffusion have been observed anecdotally, but no direct comparative studies have been done. OBJECTIVE: To compare the rate of onset and the radius of diffusion of botulinum toxin types A and B in the rhytides of the forehead. METHODS: Adults with symmetrical moderate to severe forehead wrinkles at full contracture received botulinum toxin type A (BOTOX; 5 U) on one side of the forehead and type B (MYOBLOC; 500 U) on the other side. Photographs taken at rest and full frontalis contracture were analyzed by computer, and a time-lapse motion picture was created. Radius of diffusion and time until full effect were measured. RESULTS: Botulinum toxin type B had a slightly faster onset of action than type A. All patients responded to type B quickly, whereas some had a delayed response to type A. A greater radius of diffusion was consistently observed with botulinum toxin type B, as measured by the greater area of wrinkle reduction at the doses used. CONCLUSIONS: In this comparative study of patients with symmetrical forehead wrinkles, botulinum toxin type B produced a greater area of diffusion and a more rapid onset of action than type A.     

A Double-Blind,Randomized, Placebo-Controlled,Two-Dose Comparative Study of Botulinum Toxin Type A for Treating Glabellar Lines in Japanese Subjects

BACKGROUND: Systematic, well-controlled clinical trials of botulinum toxin type A (BoNTA) in diverse patient populations are needed. The aim of this study was to characterize the safety and efficacy of 10-U and 20-U BoNTA doses versus placebo for treating glabellar lines in Japanese subjects. METHODS: A 16-week, multicenter, double-blind, randomized, placebo-controlled trial comparing 10 or 20 U of BoNTA versus placebo in 142 Japanese subjects with glabellar lines of at least moderate severity at maximal contraction. The primary efficacy endpoint was physician-rated line severity at maximal contraction 4 weeks after treatment. Secondary efficacy endpoints included physician/subject ratings and estimates of the effect's duration. RESULTS: Response rates by physician-rated line severity at maximal contraction (week 4) were 86.4% (10 U), 88.6% (20 U), and 0% (placebo, p < 0.001). Line severity at maximal contraction in each BoNTA group (p < 0.001) improved significantly from baseline at each visit. BoNTA and placebo differed significantly on all other efficacy measures. Mean duration of effect was 9.4 weeks in the 20-U group and 7.9 weeks in the 10-U BoNTA group. No serious adverse events occurred. CONCLUSION: Doses of BoNTA of 10 and 20 U are effective and safe for treating glabellar lines in Japanese subjects, and the 20-U dose provides greater efficacy and longer duration of effect.     

A Randomized, Evaluator-Blinded, Two-Center Study of the Safety and Effect of Volume on the Diffusion and Efficacy of Botulinum Toxin Type A in the Treatment of Lateral Orbital Rhytides

BACKGROUND: There has been considerable discussion about the effect of the degree of dilution of botulinum toxin (BTX) but very few scientific studies. OBJECTIVE: The objective was to observe as to whether a fivefold difference in concentration of BTX solution would produce a difference in clinical effect or duration of effect. METHODS AND MATERIALS: Twenty individuals were enrolled at two sites and a within-subject paired-comparison study was performed on the lateral orbital area with a single injection of 5 U of BTX (BOTOX Cosmetic, Allergan Inc., Irvine, CA). The results were assessed both clinically and using a computer-assisted estimation of the degree of wrinkling. RESULTS: No statistically significant differences were observed between the two sides. CONCLUSIONS: This is a small study and it may be that dilution does affect BTX result. We were, however, unable to detect any difference in this study, which suggests that the degree of dilution, at least within a fivefold margin, has only a small effect on the results of BTX injection in the lateral orbital area.     

Dose-Finding, Safety, and Tolerability Study of Botulinum Toxin Type B for the Treatment of Hyperfunctional Glabellar Lines

BACKGROUND Previous open-label studies have demonstrated that botulinum toxin type B (BTX-B, Myobloc, Solstice Neurosciences) in doses of up to 3,000 U is safe and effective in the treatment of glabellar wrinkles.
OBJECTIVE This double-blind, randomized, placebo-controlled, sequential-dose-escalation study evaluated the safety and tolerability of seven BTX-B doses ranging from 250 to 3,000 U in the treatment of subjects with hyperfunctional glabellar lines.
METHODS Participants received a single intramuscular treatment of either BTX-B or placebo at five facial sites with a 12-week follow-up period. Primary efficacy outcome measure was the Investigator Global Scale score of subject's glabellar lines at rest and at full frown. Safety was evaluated primarily on the occurrence of adverse events (AEs).
RESULTS The investigator scores demonstrated a statistically significant increasing dose–response trend in the percentage of subjects with no lines or mild lines at rest from Weeks 1 to 12 ( p= .0420) and at full frown from Weeks 1 to 8 ( p< .0001). Fifty-one subjects (36.7%) experienced AEs; the most common AE was headache not otherwise specified, experienced by 19 subjects (13.7%).
CONCLUSIONS BTX-B at doses up to 3,000 U was safe and well tolerated in the treatment of hyperfunctional glabellar lines. Treatment with BTX-B reduced hyperfunctional glabellar lines in subjects, and the duration of action appeared to be related to the dose administered. Further studies using higher doses of BTX-B for treatment of glabellar wrinkles are planned.     

The Effect of Botulinum Toxin Type A on Full-Face Intense Pulsed Light Treatment: A Randomized, Double-Blind, Split-Face Study

BACKGROUND Botulinum toxin type A (BTX) is commonly used in combination therapy, and it has been reported that periocular BTX treatment enhances the aesthetic improvements attained with intense pulsed light (IPL).
OBJECTIVE The objective was to evaluate if intradermal BTX treatment of the cheeks also enhances the efficacy of IPL.
METHODS AND MATERIALS Fifteen females enrolled in this prospective, randomized, double-blind, split-face study (14 completed, 1 lost to follow-up). All received standard IPL treatment and were randomly assigned to receive eight 0.1-mL intradermal injections of BTX (BOTOX Cosmetic, Allergan) in one cheek (8 U total dose) and eight injections of saline in the contralateral cheek. Small wrinkles and fine lines, erythema, hyperpigmentation, apparent pore size, skin texture, and overall appearance were evaluated for 8 weeks.
RESULTS A significantly higher proportion of patients showed improvement in small wrinkles and fine lines with IPL plus BTX than IPL plus saline—93% versus 29% at Week 4 ( p =.003). Adjunctive BTX also achieved a greater degree of improvement in erythema (although statistical significance was not achieved). Other efficacy measures showed comparable improvements with both regimens.
CONCLUSION The adjunctive use of BTX enhances the improvement in small wrinkles and fine lines, and possibly erythema, achieved with IPL alone.     

Efficacy of Botulinum Toxin Type A in the Treatment of Focal Axillary Hyperhidrosis

BACKGROUND Local intradermal injection of botulinum toxin Type A has become a recognized treatment for axillary hyperhidrosis. This study has investigated the efficacy of this method of treatment in terms of symptom-free interval between treatments and patients' satisfaction. We also investigated the reliance on patients' subjective assessment of the recurrence of symptoms in determining the timing of repeat injections.
METHODS All patients referred to our clinic between May 2001 and December 2005 with a diagnosis of focal primary axillary hyperhidrosis were included in this study. Data were collected prospectively in a standard proforma. Every patient received a questionnaire to complete over a 4-week period. The questionnaire included visual analogue scales for periprocedural pain, degree of dryness, satisfaction, regret, and complications. Final symptom-free interval was recorded when the patient requested a repeat injection. The data were recorded on a spreadsheet and analyzed using standard statistical methods.
RESULTS A total of 52 consecutive patients and 238 axillary injections were analyzed. The symptom-free interval ranged from 3 to 14 months with a median of 5.97 months. There were no significant complications from this treatment modality. A total of 97% of the patients were highly satisfied with only 1 patient regretting the treatment.
CONCLUSION Botulinum toxin Type A is an effective and well-tolerated treatment for axillary hyperhidrosis. Timing of repeat injections as determined subjectively by patients is comparable to studies using colorimetric and gravimetric techniques to quantify the severity of sweating prior to the administration of repeat injections.