Review of Compound W Salicylic Acid Wart Remover

• Journal List
• CMAJ
• five.182(xv); 2010 Oct xix
• PMC2952009

CMAJ. 2010 Oct 19; 182(fifteen): 1624–1630.

Cryotherapy with liquid nitrogen versus topical salicylic acid application for cutaneous warts in main care: randomized controlled trial

Sjoerd C. Bruggink, Medico, Jacobijn Gussekloo, Md PhD, Marjolein Y. Berger, Medico PhD, Krista Zaaijer, Physician, Willem J.J. Assendelft, MD PhD, Margot West.M. de Waal, PhD, January Nico Bouwes Bavinck, Md PhD, Bart West. Koes, PhD, and Just A.H. Eekhof, MD PhD

Supplementary Materials

[Online Appendices]

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Abstruse

Groundwork

Cryotherapy is widely used for the treatment of cutaneous warts in primary care. However, evidence favours salicylic acid awarding. Nosotros compared the effectiveness of these treatments also as a wait-and-see approach.

Methods

Sequent patients with new cutaneous warts were recruited in xxx primary intendance practices in kingdom of the netherlands betwixt May one, 2006, and Jan. 26, 2007. We randomly allocated eligible patients to one of iii groups: cryotherapy with liquid nitrogen every two weeks, self-application of salicylic acid daily or a expect-and-see approach. The main upshot was the proportion of participants whose warts were all cured at 13 weeks. Analysis was on an intention-to-treat ground. Secondary outcomes included treatment adherence, side effects and handling satisfaction. Research nurses assessed outcomes during home visits at four, 13 and 26 weeks.

Results

Of the 250 participants (age 4 to 79 years), 240 were included in the analysis at xiii weeks (loss to follow-up 4%). Cure rates were 39% (95% confidence interval [CI] 29%–51%) in the cryotherapy grouping, 24% (95% CI 16%–35%) in the salicylic acid group and xvi% (95% CI 9.5%–25%) in the wait-and-encounter group. Differences in effectiveness were most pronounced among participants with common warts (n = 116): cure rates were 49% (95% CI 34%–64%) in the cryotherapy group, 15% (95% CI 7%–thirty%) in the salicylic acid group and 8% (95% CI 3%–21%) in the look-and-see group. Cure rates among the participants with plantar warts (n = 124) did not differ significantly betwixt treatment groups.

Interpretation

For common warts, cryotherapy was the most constructive therapy in master care. For plantar warts, nosotros found no clinically relevant difference in effectiveness between cryotherapy, topical application of salicylic acrid or a wait-and-see approach after thirteen weeks. (ClinicalTrial.gov registration no. ISRCTN42730629)

Cutaneous warts are common.^{ane – iii} Upwardly to one-3rd of principal school children have warts, of which two-thirds resolve within two years.^{four , 5} Because warts often outcome in discomfort,⁶ 2% of the full general population and 6% of school-aged children each year present with warts to their family dr..^{7 , viii} The usual treatment is cryotherapy with liquid nitrogen or, less often, topical application of salicylic acid.^{ix – 12} Some physicians choose a wait-and-run into approach because of the benign natural course of warts and the run a risk of side effects of treatment.^{x , 11}

A contempo Cochrane review on treatments of cutaneous warts concluded that available studies were modest, poorly designed or express to dermatology outpatients.^{ten , 11} Testify on cryotherapy was contradictory,^{13 – 18} whereas the evidence on salicylic acid was more convincing.^{19 – 23} However, studies that compared cryotherapy and salicylic acid straight showed no differences in effectiveness.^{24 , 25} The Cochrane review called for loftier-quality trials in principal care to compare the furnishings of cryotherapy, salicylic acrid and placebo.

We conducted a three-arm randomized controlled trial to compare the effectiveness of cryotherapy with liquid nitrogen, topical application of salicylic acid and a expect-and-see approach for the treatment of mutual and plantar warts in primary care.

Methods

Participants

Betwixt May 1, 2006, and Jan. 26, 2007, thirty family unit practices from the Leiden Primary Intendance Research Network in the Netherlands invited all patients aged four years and older who attended the clinic with one or more new cutaneous warts to participate. We defined new cutaneous warts equally those on the peel that were diagnosed in family practice and had not been treated by a physician or dermatologist in the previous yr, regardless of previous cocky-treatment with over-the-counter medication. We excluded immunocompromised patients and patients with genital warts, seborrheic warts or warts larger than i cm in bore. Patients who fulfilled the inclusion criteria and agreed to participate were visited at dwelling by a trained research nurse, who confirmed their eligibility. Informed consent (child as well as parental informed consent for participants less than eighteen years of age) was obtained, and baseline characteristics were collected.

Study design and randomization

Nosotros stratified patients by location of warts: plantar (warts on the soles of the anxiety) or common (warts on the hands or other locations).²⁶ Participants who had both plantar and common warts were stratified according to where the majority of their warts were located. We used opaque, sealed envelopes that were numbered based on a computerized randomization listing delivered past an contained statistician to muffle allocation. After stratification by location of warts and past number of warts (< 6 warts v. ≥ six warts), random resource allotment of participants to treatment groups was done without blocking. The study protocol was approved by the medical ethical committee of the Leiden University Medical Center.

Treatment protocols

One of united states of america (1000.Z.) trained all participating family physicians and assistants working in their practices in the three 13-week handling protocols, which were designed to reflect all-time practice.^{10 , 24} Training consisted of a i-hour interactive practical session, during which all tools and techniques were demonstrated; existent warts were not used in the demonstrations.

For cryotherapy, nosotros used a high-intensity regimen of ane session every two weeks until all warts were completely gone. During each session, the participant received iii serial applications in which a wad of cotton wool wool saturated with liquid nitrogen was moved effectually on the wart. Each awarding was executed until a frozen halo of two mm around the base of the wart appeared (usually later on 2–10 seconds).

For the topical application of salicylic acid, nosotros used a white petroleum jelly containing 40% salicylic acid. We chose this concentration to provide a stronger treatment than over-the-counter products, which usually contain 17% salicylic acid. Participants assigned to this group were asked to use the salicylic acid every twenty-four hours until the warts were completely gone. They were instructed to embrace the surrounding skin with record to protect healthy skin and apply the salicylic acid on elevation of the wart with another slice of tape. Earlier each subsequent daily awarding, they used a file to pare the softened surface area of the wart.

Participants assigned to the wait-and-see group were informed about the beneficial natural form of warts and were advised not to undergo treatment (apart from over-the-counter medication) for at least 13 weeks.

Later the 13-week treatment period, all participants who still had warts could switch to another handling according to their own preferences. Participants were gratis to use over-the-counter medication during the entire follow-upwardly period just were asked to report all usage.

Outcome measures

Trained research nurses assessed outcomes during dwelling visits at 4, xiii and 26 weeks of follow-upwards, independently of the treating physicians. A wart was considered cured if it was no longer visible (pare color and skin lines were reestablished) and could not be palpated anymore by hand. The chief issue measure was the proportion of participants whose warts were all cured at 13 weeks. Research nurses assessed side effects, newly developed warts (which were non included in the master outcome assessment) and adherence to treatment. Handling adherence was considered adequate if participants had received cryotherapy at least every three weeks, had cocky-administered salicylic acrid at least iv days per week and had not undergone whatsoever co-intervention (treatment of warts other than over-the-counter medication).

In addition, participants were asked to rate treatment brunt using a 10-point scale (1 = no burden, 10 = the worst imaginable burden). A scores of six or higher was considered to reflect a substantial brunt. Participants rated treatment satisfaction using a five-indicate scale (one = very unsatisfied, 5 = very satisfied); those with a score of four or five were considered to exist satisfied.

Research nurses, family physicians and participants were non blinded to treatment allotment. For quality control, five% of the assessments were straight supervised by experienced family physicians (J.E. and One thousand.Z.).

Statistical analysis

We chose a sample size that would provide 80% power, at a significance level of 5%, to detect an absolute increase in the cure rate of 20% between the two active treatment groups. Based on a literature review, nosotros expected salicylic acid to be nearly constructive, with a 70% cure rate.^{10 , 11} A full of 91 patients were required per treatment arm.

We used the χⁱⁱ exam for all comparisons of cure rates and percentages. In our primary analysis, we compared cure rates between the three treatment arms on an intention-to-treat ground. We also calculated relative risks, gamble differences and numbers needed to treat for cryotherapy versus salicylic acid, cryotherapy versus wait-and-see approach, and salicylic acid versus wait-and-encounter arroyo.

In secondary analyses, we compared cure rates betwixt the 3 study artillery (a) with patients lost to follow-up considered not cured, (b) after excluding patients who had both plantar and mutual warts, (c) at 26 weeks' follow-upwards, (d) using individual warts equally the unit of measurement of analysis instead of patients and (e) per protocol cure rates based on reported treatment adherence.

Subgroup analyses were pre-planned for location of warts (common wart grouping five. plantar wart group), age clusters (4–12 years v. ≥ 12 years), number of warts per participant, and elapsing of warts (≤ six months v. > half-dozen months). We formally tested for result modification of treatment by location of warts using a logistic regression model.

Lastly, nosotros compared the percentages of patients with side effects and considerable handling burden between the two active treatment arms, and the percentages of patients satisfied with treatment betwixt the three arms.

An abridged version of our written report protocol can exist found at www.controlled-trials.com/ISRCTN42730629/warts.

Results

Patient characteristics

Of 303 patients recruited, we excluded 53, mainly considering they had already received treatment in the previous twelvemonth or refused to participate (Figure 1). We randomly assigned the remaining 250 participants to the cryotherapy (n = eighty), topical salicylic acid (n = 84) and wait-and-see (n = 86) groups. Baseline characteristics did not differ significantly between the groups (Table i). Seven per cent of the participants reported that they had received treatment for warts more than than one year before enrolment; 35% reported that they had treated their warts with one or more than of the following over-the-counter medications or methods in the past with no success: dimethylether propane cryotherapy (eighteen%), ointment containing salicylic acid at a concentration lower than the study ointment (12%), cutting away the warts themselves (6%) and other alternatives (6%). At study entry, 34% of the participants stated that they preferred cryotherapy, 35% salicylic acid and 4% a expect-and-come across approach (no preference given by 27%).

Choice of patients for the study.

Table 1

Baseline characteristics of 250 patients with cutaneous warts randomly assigned to one of three treatment arms

Characteristic	Treatment arm; no. (%) of participants*
	Cryotherapy n = 80	Topical salicylic acid n = 84	Await-and-see approach due north = 86
Sex, female person	45 (56)	54 (64)	50 (58)
Age, twelvemonth
4–12	33 (41)	36 (43)	39 (45)
≥ 12	47 (59)	48 (57)	47 (55)
No. of warts, median (IQR)	2 (1–iii)	2 (one–4)	2 (1–5)
Size of warts, mm, median (IQR)	four (3–5)	4 (3–five)	four (3–5)
Hindrance†	55 (69)	63 (75)	70 (81)
Location of warts‡
Plantar (soles of the feet)	39 (49)	44 (52)	45 (52)
Common (hands or other)	41 (51)	40 (48)	41 (48)
Duration of warts, mo
< half-dozen	31 (39)	37 (44)	34 (twoscore)
≥ half dozen	49 (61)	47 (56)	52 (60)
Treatment preference at baseline
Cryotherapy	33 (41)	24 (29)	29 (34)
Salicylic acid	22 (28)	33 (39)	32 (37)
Wait-and-see approach	6 (8)	ii (2)	2 (2)
No preference	xix (24)§	25 (xxx)	23 (27)

Of the 250 participants, 122 (49%) were stratified into the common wart group and 128 (51%) into the plantar wart group. In the mutual wart group, 103 participants (84%) had warts on their hands, 19 (16%) had them on parts of the body other than hands or soles of the anxiety, and 13 (eleven%) also had plantar warts. In the plantar wart group, 22 participants (17%) besides had common warts. Baseline characteristics were similar betwixt the mutual and plantar wart groups except for age distribution and duration of warts.

Follow-up and handling adherence

At 13 weeks, x participants (4%) were lost to follow up (8 refused farther participation, i had entered by fault because the wart was diagnosed as a seborrheic wart, and 1 was lost for unknown reasons). Overall, 48 (20%) of the remaining 240 participants stopped the assigned treatment protocol (see Appendix ane, available at www.cmaj.ca/cgi/content/full/cmaj.092194/DC1). During the thirteen-week follow-up menstruation, 61 participants (25%) had ane or more than new warts; no participants were referred to dermatology outpatient clinics.

Effectiveness of treatment

At 13 weeks, the cure rates were 39% (95% conviction interval [CI] 29%–51%) later on cryotherapy, 24% (95% CI 16%–35%) after salicylic acid and 16% (95% CI ix.five%–25%) afterward the wait-and-see protocol, for a relative take a chance of 1.6 (95% CI 1.0–2.6) for cryotherapy versus salicylic acid. Because the effectiveness of treatments differed between the common wart group and the plantar wart group (p for interaction 0.007), nosotros report outcomes for all patients besides as by location of warts (Tables 2 and ​ 3).

Table 2

Effectiveness of treatments at thirteen weeks, by location of warts (n = 240)

Variable	Treatment arm; no. (%) of participants cured*						p value‡
	Cryotherapy		Salicylic acid		Expect and see
	n/Northward †	% (95% CI)	n/N †	% (95% CI)	north/N †	% (95% CI)
All participants (n = 240)	thirty/76	39 (29–51)	xx/82	24 (16–35)	13/82	16 (10–25)	0.001
Age, year
4–12	16/31	52 (35–68)	15/36	42 (27–58)	11/38	29 (17–45)	0.056
≥ 12	xiv/45	31 (xx–46)	five/46	11 (5–23)	2/44	5 (1–15)	0.001
Elapsing of warts, mo
< 6	19/xxx	63 (46–78)	14/37	38 (24–54)	x/32	31 (18–49)	0.012
≥ six	eleven/46	24 (fourteen–38)	6/45	13 (6–26)	3/50	6 (2–sixteen)	0.012
Common warts (north = 116)	19/39	49 (34–64)	half-dozen/39	15 (7–30)	iii/38	eight (three–21)	< 0.001
Historic period, yr
4–12	6/12	l (25–75)	2/12	17 (5–45)	1/15	7 (2–25)	0.010
≥ 12	xiii/27	48 (31–66)	4/27	xv (6–32)	ii/23	ix (two–27)	0.001
Duration of warts, mo
< vi	10/12	83 (55–95)	two/eleven	18 (5–48)	2/13	xv (4–42)	0.001
≥ 6	9/27	33 (19–52)	4/28	14 (half dozen–31)	ane/25	four (< i–twenty)	0.006
Plantar warts (n = 124)	11/37	xxx (17–46)	14/43	33 (20–47)	10/44	23 (13–37)	0.46
Age, yr
four–12	10/19	53 (32–73)	13/24	54 (35–72)	10/23	43 (26–63)	0.54
≥ 12	one/18	six (< 1–26)	i/nineteen	v (< 1–25)	0/21	0 (0–xv)	0.34
Duration of warts, mo
< vi	9/eighteen	50 (29–71)	12/26	46 (29–65)	viii/xix	42 (23–64)	0.63
≥ 6	ii/19	eleven (three–31)	2/17	12 (three–34)	2/25	8 (2–25)	0.77

Tabular array 3

Relative measures of effect between the three handling arms at xiii weeks, by location of warts (northward = 240)

Variable	Relative risk (95% CI)	Risk departure (95% CI)	Number needed to treat for do good (95% CI)*
All participants (n = 240)
Cryotherapy five. wait and run across	2.49 (ane.41 to 4.41)	0.24 (0.10 to 0.37)	iv.2 (2.7 to 9.9)
Salicylic acrid v. await and see	1.54 (0.82 to two.88)	0.09 (−0.04 to 0.21)	12 (NNTB four.8 to ∞ to NNTH 27)
Cryotherapy v. salicylic acid	1.62 (ane.01 to two.59)	0.xv (0.01 to 0.29)	half dozen.six (iii.4 to 145)
Common warts (n =116)
Cryotherapy v. wait and see	6.17 (1.99 to 19.16)	0.41 (0.23 to 0.59)	ii.four (one.seven to 4.4)
Salicylic acid v. look and meet	1.95 (0.52 to 7.24)	0.07 (−0.07 to 0.22)	13 (NNTB iv.6 to ∞ to NNTH 15)
Cryotherapy v. salicylic acid	3.17 (1.42 to vii.07)	0.33 (0.14 to 0.53)	3.0 (1.ix to seven.1)
Plantar warts (due north = 124)
Cryotherapy five. expect and see	1.31 (0.63 to two.73)	0.07 (−0.12 to 0.26)	xiv (NNTB three.8 to ∞ to NNTH 8.ii)
Salicylic acrid v. expect and see	1.43 (0.72 to two.87)	0.10 (−0.09 to 0.29)	10 (NNTB 3.5 to ∞ to NNTH 11)
Cryotherapy v. salicylic acid	0.91 (0.47 to ane.76)	−0.03 (−0.23 to 0.18)	35 (NNTB 5.7 to ∞ to NNTH 4.iii)

In the mutual wart group, cryotherapy was most effective, with a cure rate of 49% (95% CI 34%–64%) at xiii weeks (Tables 2 and ​ iii). Further stratification by age and by duration of warts gave similar findings.

In the plantar wart group, the cure rate at thirteen weeks did not differ between the treatment arms (Tables 2 and ​ 3). Farther stratification revealed that cure rates were considerably lower amongst participants 12 years and older than among younger participants. Too, cure rates were lower amongst participants whose warts had been present for six or more months at baseline than among those whose warts had been present for a shorter duration (Table two).

Sensitivity analysis

The results at 26 weeks were concordant with the results at xiii weeks (see Appendix 2, available at world wide web.cmaj.ca/cgi/content/full/cmaj.092194/DC1). The aforementioned was true when nosotros considered that all patients lost to follow-up were not cured, or when we excluded participants with both common and plantar warts from the assay. Per-protocol analysis and assay of the cure rate of individual warts at thirteen weeks showed the same meaning results as our primary assay (encounter Appendices 3 and 4, bachelor at world wide web.cmaj.ca/cgi/content/full/cmaj.092194/DC1).

Side effects and treatment satisfaction

In both wart groups, participants experienced more side effects after cryotherapy than later on topical salicylic acid application (see Appendix 5, bachelor at www.cmaj.ca/cgi/content/full/cmaj.092194/DC1). The side effects included pain, blistering, scarring, peel irritation, skin pigmentation and crust. In the mutual wart grouping, 31% (95% CI nineteen%–46%) of the participants reported considerable treatment burden later cryotherapy and 54% (95% CI 39%–68%) after salicylic acid treatment (p = 0.040). Furthermore, 69% (95% CI 53%–82%) of participants were satisfied with treatment after cryotherapy, as compared with 24% (95% CI 13%–39%) subsequently salicylic acid treatment and 22% (95% CI 12%–38%) after the wait-and-see protocol (p < 0.001). In the plantar wart grouping, there were no differences in treatment brunt or satisfaction between the three handling groups.

Interpretation

In this pragmatic three-arm randomized controlled trial conducted in family practices, we plant that cryotherapy was the most effective therapy for common warts (mainly on hands), with 49% of patients cured later xiii weeks. Despite the fact that cryotherapy caused more frequent and more severe side effects than topical salicylic acrid application, patients were most satisfied when treated with cryotherapy. For plantar warts, nosotros found no clinically relevant difference between the treatment artillery. Regardless of treatment, children with plantar warts showed relatively loftier cure rates (about 50%), whereas plantar warts in adolescents and adults were highly persistent (cure rates of about 5%).

Although our overall relative hazard of 1.5 between salicylic acid handling and the wait-and-encounter protocol was like to the relative adventure of 1.6 from pooled data in the recent Cochrane review, our overall cure rates of 24% in the salicylic acid group and 16% in the expect-and-see grouping were lower than the cure rates of 73% and 48% in the Cochrane review at similar follow-up.^{10 , xi} This marked difference is near probable due to variation in report pattern and study population. Our primary intendance setting, pragmatic design, wide inclusion criteria, splendid follow-upwards and intention-to-treat analysis led to results that were like shooting fish in a barrel to interpret and directly applicable to daily practice in primary intendance. In contrast, the two other studies comparing cryotherapy and salicylic acrid treatment, which involved dermatology outpatients, excluded patients who had more than 5 warts, those with warts on locations other than the location under investigation, and nonattending or noncompliant patients (in our study twenty% of participants included in the assay were noncompliant).^{24 , 25} Other factors may besides exist at play, such as historic period of the patients and duration of warts before treatment, which our study showed to be significantly associated with cure rates.

Our follow-up at 26 weeks showed that the effects of treatment of mutual warts were sustainable. In the plantar wart grouping, in contrast to statistically equal effectiveness at xiii weeks, both of the active treatments might have college cure rates than a wait-and-encounter arroyo in the long term. These findings propose that the consequence of active treatments on plantar warts is delayed or that more aggressive treatment is needed because of the callosity overlying the warts.^fourteen

Limitations

As in daily practice, salicylic acid was applied by the participants themselves, which could reduce effectiveness compared with treatments applied by health professionals. Even so, nosotros explicitly recorded participants' adherence to standardized handling protocols, and intention-to-treat cure rates were concordant with results of the per-protocol analyses.

The participating patients and family unit practices were aware of the treatment allocations, because the pragmatic study design and treatment options did not secure realistic blinding. Furthermore, the research nurses who assessed outcomes were aware of the treatment allocations, because the appearance of the pare after treatment usually revealed the specific handling and because the large proportion of children often spontaneously reported the specific treatment.

Conclusion

Although earlier evidence favoured topical salicylic acid application over cryotherapy for the treatment of cutaneous warts, the results of our randomized controlled trial provides testify to support the use of cryotherapy over salicylic acrid treatment, for common warts only. For plantar warts, we found no clinically relevant difference between cryotherapy, salicylic acid treatment or a look-and-see approach after 13 weeks.

Supplementary Material

Acknowledgements

The authors thank all of the participating patients and family unit practices from the Leiden Master Intendance Research Network as well as the trial research nurses Els de Haas-van Rijn and Carin Mostert-Westdijk.

Footnotes

Funding: The study was supported by kingdom of the netherlands System for Health Research and Development (Fund Common Diseases). The organization did not accept whatever influence on the study design, the collection, analysis or estimation of data, the writing of the report or the decision to submit the paper for publication.

Previously published at www.cmaj.ca

Competing interests: None alleged.

Contributors: Jacobijn Gussekloo, Marjolein Berger, Willem Assendelft and Simply Eekhof were responsible for the study concept and pattern. Jacobijn Gussekloo, Marjolein Berger, Willem Assendelft, Jan Nico Bouwes Bavinck, Bart Koes and Merely Eekhof were responsible for the original report protocol. Sjoerd Bruggink contributed to the estimation and assay of information and drafted the manuscript. Jacobijn Gussekloo contributed to the analysis of data. Krista Zaaijer was responsible for the recruitment of participants. Krista Zaaijer, Margot de Waal and Simply Eekhof contributed to the collection of data and the interpretation or analysis of information. All of the authors revised the manuscript critically for important intellectual content and approved the final version submitted for publication. All of the authors had full access to all of the data and take responsibility for the integrity of the data and the accuracy of the assay.

This article has been peer reviewed.

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Articles from CMAJ : Canadian Medical Clan Journal are provided here courtesy of Canadian Medical Association

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Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2952009/

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