A systematic evidence-based review of treatments for primary hyperhidrosis

Figures & data

Figure 1. Hyperhidrosis treatment options and sites evaluated.

Figure 2. Flowchart on methodology used for assigning RoB and SOE ratings.

Figure 3. Systematic review flowchart.

Figure 4. Overall summary of SOE ratings and evidence synthesis for unique studies identified for appraisal (n = 32)*.

Table 1. Summary and risk of bias for aluminum salt studies.

Study and intervention(s)	HH population and design	Risk of bias	Key results/critical appraisal findings
Flanagan et al.^19 ^a20% topical aluminum chloride hexahydrate (AC) vs. botulinum toxin A (BTX-A) injections	Axillary Single-center, 12-week, randomized, parallel, open-label, study N = 50 (n = 25 AC, n = 25 BTX-A for 4 weeks); cross over at week 4 allowed for AC patients dissatisfied with treatment	Borderline to high	33.3% HDSS response rate (≥2 grade improvement) in AC-treated patients at week 4 vs. 91.7% in BTX-A group; 33.3% of AC-treated patients were “very satisfied” at week 4 vs. 87.5% of patients in BTX-A group Large cross-over (allowed at week 4) from AC to BTX-A therapy (71%) Safety: >50% of subjects treated with AC reported stinging, itching and redness, and >25% reported pain
Flanagan and Glaser^18 Aluminum chloride (15% aluminum chloride (AC) in 2% salicylic acid gel base (compared to baseline)	Axillary Prospective, open-label, uncontrolled, single-arm study (N = 30); 12-week duration	High	72% HDSS responders; 75% somewhat or very satisfied with treatment compared to baseline Safety: moderate to severe redness (14.3%) moderate to severe itching (28.6%), absent to mild pain (92.9%) and moderate pain (7.1%); 2 subjects did not complete trial due to moderate-to-severe axillary irritation (redness, itching, burning)
Goh^21 Topical aluminum chloride hexahydrate 20% W/W ethanol (AC) applied to one palm No treatment applied to other palm	Palmar Small (N = 12), W/P, single author, assessor-blinded, 6-week study	Unclear	Approximately, two-thirds likely to experience drier palms within 24 h of AC treatment, lasting for 1–2 days Weekly mean skin vapor loss difference averaged 16.4 g water/m^2/h over 4 weeks; all patients reported treated palms to be drier than untreated palms the following morning after starting treatment, and that sweating returned within 2 days of stopping treatment Safety: 1 out of 4 experienced a stinging sensation after application; one patient dropped out due to intolerable side effects
Scholes et al.^22 20% aluminum chloride applied with a brush for 1 week	Axillary One case series from two dermatology clinics (N = 65)	High	Authors state that 64/65 patients had “excellent control of sweating”; however, statements appear to be authors’ interpretation from comments received from 42 patients from one clinic who completed a questionnaire 12 months after the study had concluded Safety: 29 experienced some irritation (described as “minor” by authors, but 28 subjects reported relief following application of 1% hydrocortisone cream on the morning after treatment)

Abbreviations. AC, Aluminum chloride; AE, Adverse event; BTX-A, Botulinum toxin A; HDSS, Hyperhidrosis Disease Severity Scale; W/P, Within patient.

a SOE considered for aluminum chloride body of evidence only.

Table 2. Summary and risk of bias for anticholinergic agents.

Study and intervention	HH population and design	Risk of bias	Key results/critical appraisal findings
Glaser et al.^16 Topical 2.4% glycopyrronium tosylate (GT) pre-moistened cloth vs. vehicle (same appearance and excipient content with exception of GT)	Axillary Two distinct 4-week, randomized, double-blind, vehicle-controlled clinical trials in patients ≥ 9 years of age (N = 697)	Low	Nearly 75% of patients achieved a ≥50% reduction from baseline in axillary sweat production and 59% achieved a ≥2-point reduction in HDSS score by week 4 with GT (pooled results) ∼60% of patients had ≥4-point improvement on Axillary Sweating Daily Diary Item 2, indicating a clinically meaningful improvement in disease severity, and 58.1% rated their condition as much better (Patient Global Impression of Change) with GT Safety: AEs occurring in ≥5% in either pooled group included dry mouth (24.2% GT vs. 5.6% vehicle), application site pain, mydriasis, oropharyngeal pain, and headache; local skin reactions were reported in 30.8% GT vs. 30.3% vehicle and were predominantly mild to moderate in severity
Glaser et al.^20 Topical 2.4% glycopyrronium tosylate (GT) pre-moistened cloth	Axillary A 44-week observational open-label extension trial (N = 550) for those who completed the two trials described in Glaser 2018	N/A (used for safety only)	N/A for efficacy Safety: results were consistent with the findings in prior studies, with no new or unexpected findings; AEs were dry mouth (16.9%), blurred vision (6.7%), application site pain (6.4%), nasopharyngitis (5.8%) and mydriasis (5.3%) Long-term efficacy outcomes collected and supported findings in the two double-blind trials
Hyun et al.^24 2% topical glycopyrrolate-impregnated cotton pads (not commercially available) vs. placebo	Facial Randomized, double-blind, placebo-controlled study for 9 days investigated in subjects aged 20–66 years with facial hyperhidrosis (N = 39) *Reevaluated based on W/P design: drug/placebo split application in two halves of forehead)	Moderate	Compared with the placebo-treated sides, topical glycopyrrolate-treated sides showed a reduction in the rate of sweat production at the forehead of 36.68 ± 11.41% on day 10 (p<.025) Safety: one patient reported transient headache following treatment
Artzi et al.^23 Topical oxybutynin chloride 10% gel vs. placebo	Axillary, palmar, plantar W/P, placebo-controlled comparison (2× daily application) with randomization for 4 weeks in adults (N = 61) *Newly identified relative to Wade et al.^12	Moderate (LRR)	Palmar hyperhidrosis patients are likely to experience 25% to <50% sweat reduction as assessed by the minor starch-iodine test Approximately, three quarters (axillary), two thirds (palmar), and half (plantar) of patents reported a 1-point change in HDSS A 2-point HDSS change was reported by 9.5% (axillary), 8.3% (plantar), and 5% (palmar) Approximately, three quarters of patients reported moderate to high satisfaction Safety: Approximately, half of patients with axillary hyperhidrosis treated with oxybutynin 10% gel reported erythema and/or pruritus; patients have reported dry mouth, erythema, itching, a “sticky” feel and inconvenience of use

Abbreviations. AE, Adverse event; GT, Glycopyrronium tosylate; HDSS, Hyperhidrosis Disease Severity Scale; LRR, Large response rates; W/P, Within patient.

Table 3. Summary and risk of bias for botulinum toxin type A studies.

Study and intervention	HH population and design	Risk of bias	Key results/critical appraisal findings
Lueangarun et al.^26 Topical botulinum toxin type A liposomal cream (not commercially available) vs. Vehicle *Newly identified relative to Wade et al.^12	Axillary W/P, randomized, double-blind, vehicle-controlled 8-week trial in patients ages 18–50 (N = 20)	Moderate (LRR)	Potential for small short-term benefits of BTX-A cream based on reduced sweat production, expert panel assessments of iodine starch test, HDSS, and patient satisfaction Safety: no AEs (including local skin reactions) were observed in either treatment arm
Budamakuntla et al.^25 Botulinum toxin A injections vs. subcutaneous curettage (appears also in Table 4 for curettage results) *Newly identified relative to Wade et al.^12	Axillary W/P, open-label, 3-month comparative study of efficacy and safety of botulinum toxin A injections and subcutaneous curettage in adults (N = 20)	Moderate (LRR)	Large decrease in sweat rate consistent with HDSS score decrease After BTX-A injections, mean HDSS decreased 1.75 points at month 3 (p<.0001) and by 1.35 points at month 6 (p<.0001) After suction curettage, mean HDSS decreased 1.70 points at month 3 (p<.0001) and 1.20 points at month 6 (p<.0001) Safety: after toxin injections no patients reported pain or other AEs; after the suction-curettage procedure, 2 had bruising which resolved in 3 days; one had a painful bridle (fibrosis) formation in the surgical site persisting for 2–3 months
Montaser-Kouhsari et al.^27 ^aBotulinum toxin A injections, 250 MU (per side) vs. botulinum toxin A administered by iontophoresis *New study identified from reference review	Axillary W/P, randomized trial comparing botulinum toxin A injections to botulinum toxin A administered by iontophoresis over 6 months (N = 11)	Moderate (LRR)	Iontophoresis of BTX-A reduced sweat production (gravimetry) by 73%, 22%, and 32% after 1 week, 1 month, and 6 months, respectively; injection reduced sweat production by 84%, 76%, and 50%, respectively At month 6, all but one of the injection groups reported being very satisfied; for iontophoresis, no participant reported being very satisfied, 9 reported being satisfied, and 2 reported dissatisfaction Safety: no AEs other than pain were reported. Pain perception (VAS score 0–100) was significantly lower in with iontophoresis vs. injection (15.0 vs. 20.0, p<.05)
Yamashita et al.^33 Botulinum toxin A 60 U in right palm injections vs. no treatment *Reevaluated based on W/P design	Palmar W/P, non-randomized, 6-month clinical trial in adults (N = 27)	Moderate (LRR)	Quantity of sweat on the treated hand decreased to approximately one-fifth at one month after injection. Sweat quantity increased slightly over time but remained less than half at 6 months after injection; significant difference was observed when compared to before injection. Safety data were not presented; authors note “very little effect on grip strength”
Schnider et al.^32 Botulinum toxin A injections (BTX-A; Dysport) 120 units vs. placebo (saline) *Reevaluated based on W/P design	Palmar W/P, randomized, double-blind, 13-week comparison in adults with socially handicapping palmar hyperhidrosis (N = 11)	Moderate (LRR)	Mean sweat reduction of 40% from baseline (digital images) and a 40% improvement using a visual analog scale were reported at 8 weeks (p≤.002) with BTX-A; neither the objective measurement nor the subjective rating showed a statistically significant reduction of sweating in the placebo-treated palms Safety: no serious AEs; 3 patients reported minor handgrip weakness in the BTX-A-treated hand, and 3 reported injections were more painful in BTX-A-treated hands vs. placebo
Lowe et al.^30 Botulinum toxin A injections (BTX-A) vs. placebo (normal saline) *Reevaluated based on W/P design	Palmar W/P, randomized, 28-day comparison in adults ages 18–80 (N = 19 each group)	Moderate (LRR)	Patients experienced a decrease in sweat production of approximately two thirds with BTX-A injections and about one third with placebo at 28 days; 17/17 rated the treatment as successful in the BTX-A-treated palm vs. 2/17 with placebo (p<.0001) Safety: no major AEs reported; 4 patients reported AEs (hand or finger numbness of short duration, pain in hand)
Glogau^28 Topical botulinum toxin A (200 U) combined with proprietary transport peptide (not commercially available) vs. vehicle *Reevaluated based on W/P design	Axillary W/P, randomized, vehicle-controlled 4-week trial (N = 12)	Moderate (LRR)	Week 4 gravimetric sweat reduction was 65.3 ± 21.5% (BTX-A) vs. 25.3 ± 66.2% (vehicle; p<.05); minor’s iodine starch consistent with large response rate in BTX-A group Safety: no systemic AEs were reported. Local AEs (n = 4) occurred in vehicle-treated axillae and included mild folliculitis, tenderness, erythema, and eczema
Ibrahim et al.^29 Onabotulinumtoxin-A injections vs. suction-curettage (appears also in Table 4 for curettage results) *Reevaluated based on W/P design	Axillary W/P, randomized, comparative study (unblinded) in adults 18–65 with 6-month follow-up (N = 20)	Moderate (LRR)	At month 3, toxin injections decreased sweat production by 72.1% vs. 60.4% for suction-curettage, p=.29 Duration of effect was ∼6 months Toxin injections resulted in a larger decrease in HDSS than suction-curettage by 0.80 points (month 3; p=.0002) and 0.90 points (month 6; p=.0017) Safety: after toxin injections, none of the 20 patients reported discomfort or adverse reactions; after suction-curettage, patients reported axillary discomfort for about a week; 3 patients in the suction-curettage group reported hyperpigmentation
Naver et al.^31 Botulinum toxin A injection vs. no treatment *Reevaluated based on W/P design	Axillary; palmar W/P, unblinded study comparing treated vs. non-treated axilla (n = 13), and/or palms (n = 19) (N = 28 total); 1-year follow-up	Borderline (LRR)	Consistent pattern of improvement in all outcomes Sweating disappeared in 8/13 (axillary) and 5/19 (palmar) or was markedly reduced in another 5/13 (axillary) and 10/19 (palmar) Duration of effect was 2 to 5 months Safety: reduced finger grip in two-thirds of palmar patients; 2 patients with intense pain from injection
Heckmann et al.^17 Botulinum toxin A injection vs. placebo *Reevaluated based on W/P design	Axillary W/P, multicenter, randomized, placebo-controlled, 2-week study (26-week follow-up) (N = 145)	Low (LRR)	Large (approximately 88%) decrease in mean rate of sweat production at week 2 in botulinum toxin A treated group; at week 24, sweat production was reduced by approximately 65% (open label after 2 weeks) Safety: no major AEs reported during first 14 weeks. Temporary adverse effects included headache in 4 patients, muscle soreness of the shoulder girdle in 2, increased facial sweating in 1, and axillary itching in 1

Abbreviations. AE, Adverse event; BTX-A, Botulinum toxin A; HDSS, Hyperhidrosis Disease Severity Scale; LRR, Large response rate; W/P, Within patient.

^a SOE considered for botulinum toxin A injection body of evidence only.

Table 4. Summary and risk of bias for medical devices that alter eccrine glands.

Study and intervention	HH population and design	Risk of bias	Key results/critical appraisal findings
Fatemi Naeini et al.^35 Fractionated microneedle radiofrequency (FMR) vs. sham *Reevaluated based on W/P design	Axillary (severe) W/P, single-blind, sham control (N = 25); three sessions of FMR (1 MHz) at 3-week intervals	Moderate	HDSS scores (mean ± SD) at week 21 went from 3.46 at baseline to 1.87 ± 0.61 (FMR) and 3.38 ± 0.49 (control) (p<.001) More than three quarters of patients achieved a 1- or 2-point decrease in HDSS score (week 21) 80% of patients reported >50% satisfaction at the end of the study (week 21) Safety: most common side effects were erythema (68%) and pinpoint bleeding (56%)
Bechara et al.^34 Laser vs. untreated *Reevaluated based on W/P design	Axillary W/P, randomized, half-side-controlled trial (N = 21); 5 cycles of an 800-nm diode laser	Moderate	Significant reduction in sweat rate was observed on the laser-treated side (median 89 mg/min vs. 48 mg/min; p<.001) and the untreated contralateral side (median 78 mg/min vs. median 65 mg/min; p=.04) No significant difference was found between the treated and untreated sides (p=.10) Safety: no serious complications during laser treatment were reported; one instance of axillary skin depigmentation was observed that resolved during the 12-month follow-up
Nestor and Park^36 Microfocused ultrasound plus visualization vs. sham *Reevaluated based on W/P design	Axillary Two W/P, randomized, double-blind, sham-controlled pilot studies (N = 14 and N = 20)	Moderate	Study 1: ≥50% of patients achieved a ≥50% reduction in gravimetric sweat production (day 120) Study 2: HDSS response (day 60) was 67% (micro-focused ultrasound plus visualization) vs. 0% (sham) (p=.005) Study 2: HDSS response maintained (month 12) Safety: AEs were found to be mild; most common (>80%) were axilla tenderness or soreness
Microwave thermolysis
Suh et al.^38 Microwave thermolysis Included for analysis of Safety only *New study identified from reference review	Axillary Case report of a thin, healthy male patient diagnosed with transient median and ulnar neuropathy following microwave treatment for the treatment of axillary hyperhidrosis	Safety only	Patient reported numbness and weakness in the first and second fingers and decreased ability to abduct his left arm Symptoms resolved at six months after intensive physical therapy
Chang et al.^39 Microwave thermolysis Included for analysis of safety only *Newly identified relative to Wade et al.^12	Axillary Case report of a thin, healthy female patient diagnosed with median and ulnar nerve injury following microwave treatment for the treatment of axillary hyperhidrosis (level 5 microwave for 1.5 s at a size of 140 × 80 mm^2)	Safety only	Patient experienced severe swelling, numbness and inability to raise her left arm immediately following treatment Palmar skin was noted to be discolored Sensory and motor deficits had not resolved at the 6-month follow-up
Liposuction curettage
Budamakuntla et al.^25 Subcutaneous curettage vs. botulinum toxin A injections (appears also in Table 3 for botulinum toxin results) *Newly identified relative to Wade et al.^12	Axillary W/P, open-label, 3-month comparative study of efficacy and safety of botulinum toxin A injections and subcutaneous curettage in adults (N = 20)	Moderate (LRR)	The mean percent reduction in the resting sweat rate (gravimetry, weighed filter paper) 3 months after BTX-A injections was 80.32% and 3 months after the suction-curettage was 79.79%, p=.2072 After botulinum toxin A injections, mean HDSS score decreased 1.75 points at month 3 (p<.0001) and by 1.35 points at month 6 (p<.0001) After suction curettage, mean HDSS score decreased 1.70 points at month 3 (p<.0001) and 1.20 points at month 6 (p<.0001) Safety: after toxin injections no patients reported pain or other AEs; after the suction-curettage procedure, 2 patients had bruising which resolved in 3 days; one patient had a painful bridle (fibrosis) formation in the surgical site which persisted for 2–3 months
Ibrahim et al.^29 Suction curettage vs. onabotulinumtoxin-A injections (appears also in Table 3 for botulinum toxin results) *Reevaluated based on W/P design	Axillary W/P, randomized, comparative study (unblinded) in adults 18–65 with 6-month follow-up (N = 20)	Moderate (LRR)	At month 3, toxin injections decreased sweat production by 72.1% vs. 60.4% for suction-curettage, p=.29 Duration of effect was ∼6 months Safety: after toxin injections, none of the 20 patients reported discomfort or adverse reactions; after suction-curettage, patients reported axillary discomfort for about a week; 3 patients in the suction-curettage group reported hyperpigmentation
Tronstad et al.^37^aTumescent suction curettage vs. curettage only *Reevaluated based on W/P design	Axillary W/P, unblinded, half-side comparison randomized, controlled trial in adults (N = 22); 12-month follow-up	Moderate	Five patients withdrew or did not meet for any follow-up examination; 17 subjects analyzed Significant reduction in sweating after both interventions lasting ≥ 12 months was found per skin conductance, gravimetry and visual analogue scale scoring Significantly better effect of tumescent suction curettage than curettage only; curettage reductions were approximately 40%, 30%, 35%; gravimetric measurements were reported as significantly lower at 6 (p<.05) and 12 months (p<.01) vs. before treatment but effect size estimates not possible from Figure 2. Safety: no infections requiring systemic antibiotics or hematoma after one week; one patient receiving suction with curettage experienced postoperative neuropathic pain, lasting through the observational period; no scarring was observed

Abbreviations. AE, Adverse event; HDSS, Hyperhidrosis Disease Severity Scale; LRR, Large response rate; W/P, Within patient.

^a SOE considered for tumescent suction curettage body of evidence only.

Table 5. Summary and risk of bias for iontophoresis studies.

Study and intervention	HH population and design	Risk of bias	Key results/critical appraisal findings
Dahl^41 Tap water iontophoresis vs. Sham *Reevaluated based on W/P design	Palmar W/P, double-blind, randomized single center trial in adults (N = 11); 3-months duration	Moderate	Iontophoresis-treated patients achieved a median reduction in sweating compared to the untreated side of 38% (p<.01) after a median number of 10 treatments of 4 mA of direct current compared to the untreated side (baseline sweating was not reported) 6 patients continued maintenance treatment every second week and achieved an 81% (median) reduction at 3 months (p<.05) Satisfaction: not assessed. Duration of effect: 2 weeks Safety: no AEs (e.g. soreness, erythema) reported
Karakoc et al.^42 Direct electrical current based on tap water iontophoresis vs. placebo *Reevaluated based on W/P design	Palmoplantar W/P, blinded, interrupted time-series study with objective measurement by non-blinded assessors (N = 15); 5 weeks duration	Moderate	Significant change only with direct current iontophoresis treatment (baseline sweating rate approximately 3 g/h and post-treatment sweating rate <0.5 g/h, i.e. more than 80% reduction), but not with alternating current sham treatment suggesting that direct electrical current iontophoresis for palmoplantar HH is effective in reducing sweat intensity
Stolman^40 Tap water iontophoresis (electrode exposed to 90 V and 12–12 mA direct current) vs. control hand with tap water and no electrode *Reevaluated based on W/P design	Palmar W/P, unblinded, placebo controlled, 3-week study in adults (N = 18)	Borderline	“Marked reduction” in sweating of the treated hand was reported by 15/18 treated subjects compared to no reduction in the untreated hand Objective assessment by starch-iodine imprint confirmed subjective reports; 2 subjects did not improve subjectively or by starch-iodine imprint Safety: 3 patients experienced slight and transient vesiculation of the skin; 12 patients reported redness for several hours after treatment; 2 patients reported intermittent hand tingling sometimes lasting several days
Na et al.^44 Non-standard “dry-type” iontophoretic device (dry hand-held iontophoresis device; 5–15 mA direct current) *Reevaluated based on W/P design	Palmar W/P, unblinded, 2-week trial in adults 18–34 years of age (N = 10)	Borderline	Patients treated with 5–25 mA for 30 min daily for 1 week, then every other day for 1 week with dry-type iontophoresis reported a sweat reduction of 33–51% (average 42.7% reduction in treated palm vs. 1.8% in untreated palm) of baseline Duration of effect: 2 weeks (end of study) Safety: no major AEs; erythema, mild local burning and dark lines were reported (no numbers or percentages reported)
Choi et al.^45 Dry iontophoresis Included for analysis of safety only *Reevaluated based on W/P design	Palmar (N = 23)	Safety only	N/A for efficacy Safety: two subjects dropped out after experiencing pruritic erythematous macules and asymptomatic hyperpigmented linear streaks on the treated left hands during the first week of treatment; the pruritic erythematous macules were relieved by application of a topical steroid agent for a week, and the asymptomatic hyperpigmented linear streaks disappeared spontaneously after discontinuing the electric device Safety: two cases of mild local adverse effects were noted.
Kim et al.^43 Tap water iontophoresis vs. sham *Newly identified relative to Wade et al.^12	Palmar Randomized, single-blind (patients only) controlled trial in adults and children ≥13 years of age (N = 29); 2 weeks of treatment with 6-week follow-up	High	85–90% of patients receiving iontophoresis may achieve grade 2 or 3 (mild or moderate) improvement on the starch-iodine test at 2 and 3 weeks compared to approximately 30% of patients receiving sham treatment at week 2 and 15% of sham treatment patients at week 3 Mean sweat secretion rate at week 2 decreased by 91.8% in the iontophoresis group vs. 39.1% in the sham group. At 3 weeks, the respective decreases in the mean secretion rate were 85% and 18.0% Duration of effect: 3 weeks Safety: one subject reported localized erythema of both hands. No major AEs; larger, longer studies are needed to adequately assess safety

Abbreviations. AE, Adverse event; HDSS, Hyperhidrosis Disease Severity Scale; LRR, Large response rate; W/P, Within patient.

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