ORIGINAL ARTICLE

Observational Study with a New Portable Cryosurgery Device, HYDROZID®,

in Superficial Epidermal Lesions: An Indian Experience
Bangaru H, Shivani Mishra1, Sonam S. Sachan2, Sonam Ramrakhiani3
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Abstract From the Department of

Background: Cryosurgery remains an important treatment modality in dermatology Dermatology, Mysore Medical
College and Research Institute and
practice. HYDROZID®, a new portable cryosurgery medical device using norflurane as a
Associated Hospitals, K R Hospital,
cryogen, was recently introduced in the Indian market. This paper reports the findings
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Mysore, Karnataka, 1Consultant

of the phase IV study conducted in India. Aims: This is a prospective phase IV study Dermatologists, Vighnaharta
to evaluate its safety and efficacy in the treatment of superficial epidermal and dermal Multispeaciality Hospital, APMC
lesions. Methods: The study was conducted across 4 centres in India. The cryosurgery Compound, Pachora Central,
cycles were decided based on the skin lesion considered for the treatment. Safety Pachora, Jalgaon, Maharashtra,
2
Consultant Dermatologists, Brij
and efficacy parameters were assessed at day 1, day 7, day 14, day 30 (±2) (end of Medical Centre Pvt. Ltd., Panki,
treatment), and day 60 (±2) after the initial cryosurgery treatment. The local skin Kanpur, Uttar Pradesh, 3Consultant
reactions scale, pain VAS scale, and Vancouver scale for assessment of pigmentation and Dermatologists, Srishti Clinic
scarring were used for the assessment of cutaneous reactions. Assessment of efficacy Dermatology and Aesthetic Centre,
was done by evaluating the total disappearance of skin lesions at the end of the study Thane, Maharashtra, India
visit. Results: Ninety‑seven patients completed the study. The reported post‑procedural
pain was mild to moderate and subsided over the period of 24 hours. There was no pain Address for correspondence:
observed in 84.76% of patients at the end of 24 hours. Complete disappearance of the Dr. Bangaru H,
Department of Dermatology,
lesion was seen in 47.4% of patients at the end of the study, while the reduction in
Mysore Medical College
the diameter of skin lesions by more than 50% was observed in 79.38% of patients. and Research Institute and
Conclusion: The data from this study support good clinical tolerability and safety of the Associated Hospitals,
Hydrozid® portable cryo device. K R Hospital, Irwin Road, Mysore,
Karnataka ‑ 570 001, India.
Key Words: Cryosurgery, cutaneous lesions, Hydrozid, norflurane, portable cryosurgery spray, E‑mail: dermaresearch2023@
superficial skin lesions gmail.com

Introduction many other cryogens such as Freon 12, Freon 22, solid
Cryosurgery is an effective and efficient method carbon dioxide, and liquid helium are available for
for treating a wide range of conditions. Cutaneous use.[4,8] These cryogens except the traditional liquid
cryosurgery is popular being an out‑patient procedure nitrogen achieve temperatures of −13°F to −58°F (−25°C
with demonstrated safety, effectiveness, low cost, to −50°C) and work by the direct effects of freezing
ease of use, lack of need for anaesthetics, and good on the cells, thereby changing their osmolarity causing
cosmetic results.[1‑3] As an effective alternative to vascular stasis.
several invasive techniques, cryosurgery has evolved Cryosurgery is used as routine care in various conditions
into a mainstay of therapy in dermatology practice. It such as superficial lesions, for example, warts and skin
causes in situ tissue destruction by the application of tags. Norflurane, a medically approved gas, is one of
extremely low temperatures. The resulting cryogenic the newer cryogens. It is non‑toxic and non‑flammable
lesion is characterised by sharply circumscribed and has no propensity to cause ozone depletion in the
necrosis corresponding to the volume of frozen atmosphere. A portable aerosol‑based cryosurgery medical
tissue and cryogenic lesion due to the effect of this device using norflurane spray as a cryogen (Hydrozid®)
tissue freezing.[4‑6]
This is an open access journal, and articles are distributed under the terms of
It includes rapid cooling, slow thawing, and repetition the Creative Commons Attribution‑NonCommercial‑ShareAlike 4.0 License,
of the freeze/thaw cycle.[7] Apart from liquid nitrogen, which allows others to remix, tweak, and build upon the work non‑commercially,
as long as appropriate credit is given and the new creations are licensed under
Access this article online the identical terms.
Quick Response Code: For reprints contact: WKHLRPMedknow_reprints@wolterskluwer.com
Website: https://journals.lww.com/ijd
How to cite this article: Bangaru H, Mishra S, Sachan SS, Ramrakhiani S.
Observational study with a new portable cryosurgery device, HYDROZID®,
in superficial epidermal lesions: An Indian experience. Indian J Dermatol
DOI: 10.4103/ijd.ijd_636_23 2024;69:425-31.
Received: June, 2023. Accepted: February, 2024.

© 2024 Indian Journal of Dermatology | Published by Wolters Kluwer - Medknow 425

 Bangaru, et al.: Portable cryosurgery device - Indian experience

has recently been introduced in the major markets of size, the number and duration of the cryosurgery cycles
the world. It was registered in India in the year 2021 were planned by the study investigator. Recommended
for its use in dermatology. Hydrozid® has been in the treatment duration per lesion type was provided to
world market since its first marketing authorisation in investigators [Table 1]. Patients were treated with the
Denmark in 2013 and can be used in adults and children study product on day 1 and with scheduled follow‑up
above 5 years of age. The canister contains 200 ml at visit 3 (day 7), visit 4 (day 14), and visit 5 (day
cryogen that provides spray actuation ranging from 34 30 ± 2). Cryosurgery treatment with the investigational
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to 53 of 36 seconds, each depending upon the trigger product could be repeated on visit 3, 4, or 5 based on
pressure and the number of fingers used by the user for the status of the treated superficial lesions. Visit 6 on
the trigger. day 60 (±2) was the safety follow‑up visit after the end
of treatment on day 30 (±2).
Although the terms cryotherapy and cryosurgery are
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sometimes interchangeably used,[9,10] the term cryosurgery The primary objective of the study was to evaluate the
is more specific in connection with the use of cryogens safety of the study product. Safety‑related endpoints
where the target tissue is destroyed by controlled included the incidence of any treatment‑related adverse
freezing, while the term cryotherapy covers the whole events (AEs), severe AEs and serious AEs (SAEs),
body cooling as done to reduce inflammation among treatment‑related local skin reactions (LSRs) according to
athletes.[11‑14] This paper presents the results of the the Local Skin Reaction (LSR) scale, the intensity of pain
post‑marketing study conducted with the investigational assessed by the patient according to VAS scale (no pain,
product (Hydrozid®) to assess its safety and efficacy in mild, moderate, severe, worst pain), and the incidence
the treatment of superficial epidermal and dermal lesions rate of hypopigmentation and scarring following study
in the Indian population. treatment assessed by the investigator using Vancouver
Scar Scale.[15] The scarring was evaluated on three
Material and Methods parameters: changes in skin vascularity, pliability, and
This was a prospective, open‑label, non‑comparative, height of the treated skin site. AEs/SAEs were assessed
multi‑centre, post‑marketing study. The study was at all post‑treatment visits. The intensity of pain was
registered on the national clinical trial portal of assessed immediately after treatment as well as at 2 h,
India (CTRI number CTRI/2021/12/038357), and all the 4 h, 8 h, and 24 h post‑treatment. The incidence rate
sites obtained approval from the respective Institutional of hypopigmentation, hyperpigmentation, and scarring
Ethics Committees before to the study initiation. following study treatment was assessed at all visits.
Patients were screened for enrolment at visit 1 (day 0) The secondary objective of the study was to assess the
after obtaining informed consent as per the eligibility efficacy of the study product. The efficacy endpoint was
criteria pre‑defined in the study protocol that included defined as the total disappearance of skin lesions at
male and female patients between 18 and 65 years the end of the study visit (day 60 ± 2) in the study
of age (both inclusive) with at least one superficial population. Standardised photographs of lesions were
epidermal and dermal lesion such as plantar wart, obtained at all visits. In addition, the proportion of
verruca vulgaris, verruca plana, seborrheic keratosis, patients with a reduction in diameter of the skin lesion
lentigo (facial), lentigo (non‑facial), acrochordon, from the baseline to the end of the study by 50%
actinic keratosis (facial), actinic keratosis (non‑facial), was assessed. The pain intensity and total mean pain
and molluscum contagiosum lesions of a diameter scores at 2 h, 4 h, 8 h, and 24 h after treatment were
between ≥5 mm and ≤10 mm in an area suitable for
treatment. Table 1: Recommended maximum duration of
The main exclusion criteria included patients presenting treatment with the study product (HYDROZID)® per
open wounds, cuts, bruises, eczematous skin, scars, treatment day
or tattoos in the location of the treatment, with a Skin lesion Maximum treatment time
known history of melanoma, hypersensitivity to cold Verruca plantaris 36 (6×6 sec)
insults such as cryoglobulinaemia, Raynaud’s disease, Verruca vulgaris 36 (6×6 sec)
cold urticaria, blood dyscrasias, or uncertain diagnosis. Verruca plana 18 (6×3 sec)
Participants were not permitted to use any other Keratosis seborrhoiea 36 (6×6 sec)
treatment modalities for the skin lesion during the Lentigo (facial) 12 (6×2 sec)
study. The study consisted of a treatment period of Lentigo (non‑facial) 36 (6×6 sec)
30 ± 2 days and a safety follow‑up visit at day 60 ± 2 Acrochordon (skin tag) 36 (6×6 sec)
following the treatment initiation. Keratosis actinica (facial) 12 (6×2 sec)
Eligible patients were scheduled for enrolment at the Keratosis actinica (non‑facial) 36 (6×6 sec)
visit 2 (day 1). Based on the skin lesion type and its Molluscum contagiosum 18 (6×3 sec)

426 Indian Journal of Dermatology | Volume 69 | Issue 6 | November-December 2024

 Bangaru, et al.: Portable cryosurgery device - Indian experience

compared to the pain perceived immediately after the in the study were Asian. Table 2 provides the types of
study treatment. cutaneous lesions requiring study treatment presented
by the patients. No serious or severe adverse events
The investigational study product,
related to the study treatment were observed throughout
Hydrozid® (manufactured by Bibawo Medical Denmark),
the study. The most common treatment‑related AEs
is a portable cryosurgery aerosol device containing
reported were LSR and hypo‑ or hyperpigmentation.
norflurane gas and a delivery unit (canister, valve, and
The percentage of patients presenting LSR following the
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spray head) of a total weight of 252 g with application

initial study treatment was 48.57% on day 1 (visit 2),
templates.
69.39% on day 7 (visit 3), and 55.67% on day 14 (visit
It delivers temperatures below minus 50°Celsius to the 4). At visit 5 and visit 6, 73.20% and 94.85% of patients,
area of treatment. The investigational study product was respectively, did not report any LSRs. Table 3 provides
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used as recommended by the manufacturer. Norflurane the types of LSRs reported with the previous treatment
spray was applied to a lesion from a distance of 2 cycle.
to 3 cm and for 2 to 6 seconds, depending upon the
Mild pain was observed in 52.38% of patients, and
location and type of the lesion [Table 1].
moderate pain was observed in 43.81% of patients
Several repeated freeze‑thaw cycles were given on each immediately after therapy using the VAS scale. The pain
treatment day with a maximum of 6 spray applications subsided over the next 24 hours and did not require
of 6 seconds each (total maximum treatment of the use of any analgesics. There was no pain observed
36 seconds). The investigators used a stopwatch to in 84.76% of patients at the end of 24 hours [Table 4].
accurately measure the treatment duration. Records were Patients reported relief from pain at 2 hours and
maintained regarding cryotherapy details such as date, thereafter.
time, number and duration of cycles, and frequency of
administration. All the records were collected in the Table 2: Types of cutaneous presentations
individual patient files and case report forms.
Types of skin lesions presented by Number of patients (%)
Statistical considerations the patients n=105
Acrochordon 57 (54.29%)
This study was mandated by the Indian drug
Molluscum contagiosum 02 (01.90%)
authorities (CDSCO, Central Drug Standard Control
Organisation) to demonstrate the safety of the Periungual warts (hands) 01 (0.95%)
investigational product. The sample size of 100 subjects Seborrheic keratosis 04 (03.81%)
was considered adequate to fulfill this request. The Verruca plantaris 16 (15.24%)
analyses of safety and efficacy endpoints were done Verruca vulgaris 25 (23.81%)
using descriptive statistics. The comparisons of the
mean pain score between different post‑treatment
Table 3: Percentage (%) of patients with observed
time points were performed using the Student t‑test.
local skin reactions following treatment
The reduction in the diameter of the lesion from the
Parameters Visit Visit Visit Visit Visit Visit
baseline to the end of the study was calculated using 1# 2* 3* 4* 5* 6**
Wilcoxon signed rank test. Statistical analysis was done Erythema (%) NA NA 20.41 18.56 11.34 1.03
using SAS 9.1 version. Flaking/scaling (%) NA NA 11.22 9.28 6.19 2.06
Crusting (%) NA NA 18.37 9.28 5.15 1.03
Results
Swelling (%) NA NA 14.29 14.43 4.12 1.03
A total of 105 patients were enrolled at the 4 centres Erosion/ulceration (%) NA NA 5.1 4.12 0 0
after obtaining their informed consent and confirming #
screening visit; * treatment days; ** post‑treatment follow‑up
the eligibility criteria as pre‑defined in the protocol. visit
The study was conducted between December 2021 (first
patient enrolment on 4 December 2021) and August
2022 (the last patient completing the study on 12 August Table 4: Pain intensity after using study
2022). Four patients withdrew consent after enrolment products (VAS scale) reported by patients (n=105)
and receiving treatment on day 1. Four patients were lost PARAMETER No Mild Moderate Severe Worst
to follow‑up during the study period; thus, 97 patients pain pain
Immediately after therapy 1 55 46 3 0
completed the study per protocol. All patients enrolled
in this study were in the range of 18 to 65 years of at 2 hrs post therapy 13 68 23 1 0
age (both inclusive); 62.86% were male, and 37.14% at 4 hours post therapy 56 38 10 1 0
were female. The mean [standard deviation (SD)] age at 8 hours post therapy 81 21 2 1 0
of the patients was 35.3 (12.14) years. All the patients at 24 hours post therapy 89 15 0 1 0

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 Bangaru, et al.: Portable cryosurgery device - Indian experience

There was a statistically significant difference between consultations in general practice remains about 6%. Most
the pain intensities at 2 h, 4 h, 8 h, and 24 h after of the consultations seek the removal of these cutaneous
treatment as well as the total mean pain score compared lesions due to the poor cosmetic appearance.[16‑18]
to the pain perceived immediately after the study
In our study, the investigators used the newly
treatment [Figure 1] (P value: <0.0001).
introduced portable, lightweight, easy‑to‑use Hydrozid
In none of the patients, hypo‑ or hyperpigmentation cryosurgery device containing a non‑flammable medical
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was reported at visit 3. Hypopigmentation and gas, norflurane. The study product is supplied with
hyperpigmentation were observed in 9.28% and 5.15% applicators for the focused spray to avoid the exposure
of patients, respectively, at visit 4 and in 13.40% and of the cryogen to the uninvolved cutaneous areas
9.28% of patients, respectively, at visit 5. Subsequently, (a spot‑freeze technique).
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the rate of hypopigmentation decreased to 2.06% at

The investigational product delivered effective, rapid,
visit 6, whereas the percentage of hyperpigmentation
and low‑risk cryosurgical treatment for a wide range of
remained the same. Scarring was not observed in any of
cutaneous lesions. The treatment did not require the use
the patients.
of any local anaesthetic. There was no preparatory time
There were no instances of any post‑procedural required as with traditional cryo‑equipment, laser, or
infections. There was no need to use any topical traditional invasive cautery techniques requiring the use
anaesthetic agent, and no prior preparation was of an anaesthetic; thus, the treatment time was also very
necessary. The reduction in skin lesion diameter from short. The study product causes cell death through the
the baseline (before treatment) to the end of the study rapid formation of intra‑ and extracellular ice crystals.
was significant (P value < 0.0001). At the end of the
Laboratory data showed that the temperatures were
study, 47.4% of patients had complete disappearance
constantly maintained below ‑50°Celsius for a relatively
of the lesion. Among these patients, 79.3% of patients
long time, for example, 240 seconds for 6 × 6 (36)
had more than a 50% reduction in the diameter of the
second applications with thaw periods between freezing,
lesion [Figure 2].
and did not fall below ‑61 degrees Celsius.[19] This can
At visit 4 and at visit 5, 62 and 43 patients, respectively, probably explain the absence of scarring observed in our
received a new treatment with the study product, study. Scarring, associated with lowered temperatures, is
while 35 patients and 54 patients, respectively, did common with other cryogens.[20] Liquid nitrogen has the
not require new treatments due to the resolution of lowest boiling point (–196°C) and possesses the greatest
their skin lesions. 7.22% of patients had resolution at tissue‑freezing capacity among all available cryogens.
visit 4 (day 14), and 21.65% of patients had resolution However, due to its severe peak coldness, it tends
at visit 5 (day 30) and did not require any further to cause higher local side effects and post‑treatment
cryo‑treatment [Images 1 and 2]. scarring is common.[21,22]

Discussion The most common side effects of cryosurgery are

hypo‑ and hyperpigmentation, which are the result of
Among the skin conditions, superficial skin lesions of tissue freezing, and necrosis, followed by tissue repair
various types including skin tags and various types of and the healing process. In this study, hypopigmentation
warts are very common and affect approximately 10–20% and hyperpigmentation were observed in 2.06% and
of the population. However, the reported percentage of

50 47.42
30 26
Average pain score

40
% patients

20 30
15.7 21.65
20
10 7.9 10 7.22
3.03
4.2 0
2.1 0
Baseline Day 1

Follow up day 7

Follow up day 14

Follow up day 30

Follow up day 60

0
immediately
post therapy

at 2 hours
post therapy*

at 4 hours
post therapy*

at 8 hours
post therapy*

at 24 hours
post therapy*

Time in hours post therapy follow up days

* p < 0.0001
Figure 2: Percentage of patients with total disapperance of skin lesions by Day 60
Figure 1 : Total Mean Pain Score (VAS scale) with HYDROZID

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Image 1: Planter warts before, during, and at end of therapy

9.28% of patients, respectively, at visit 6, while the for skin tags depending on the cryosurgery device used.[24]
vast majority of patients (88.66%) experienced no In our study, the treatment did not require the use of any
pigmentation issues. The freezing temperature delivered topical anaesthesia as well as any post‑treatment wound
by the study product as well as the short treatment care. There were no instances of any post‑procedural
duration could probably explain these findings. The pain infections. The patients could resume their daily activities
experienced by the patients was bearable and did not soon after the treatment avoiding absenteeism from
warrant the use of any analgesics. school or work on the days of the treatment.
The study product was effective in the resolution of Although liquid nitrogen is the most commonly used
cutaneous lesions among 47.42% of the participants with cryogenic agent, it does have certain limitations, besides
the vast majority of patients being treated for warts and the above‑mentioned risk of post‑treatment scarring.
skin tags. The literature on cryotherapy effects is scarce; From the clinician’s perspective, using traditional liquid
however, the cure rate of warts in this study is in line with nitrogen requires a special licence for inventory as per
the results of a meta‑analysis[23] with a cure rate of 38% local country‑specific regulations including management
for hand and foot warts and with a cure rate of 7 to 64% of accessories and supplies, its filling and secure use, and

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 Bangaru, et al.: Portable cryosurgery device - Indian experience
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Image 2: Acrochordan before, during, and at end of therapy

storage. Liquid nitrogen is non‑inflammable but supports aerosol‑based cryosurgery medical device using the
combustion, and the nitrogen cylinders can explode if norflurane spray as a cryogen) was safe and effective with
they encounter high temperatures due to the expansion a good benefit‑risk profile. No treatment‑related serious or
of the gas within the cylinder/canisters. severe adverse events occurred, no scarring was observed,
The results of this study provide real‑world clinical and the hypo‑ or hyperpigmentation was rare at 60 days
data that were scarcely available for the study product. post‑initial treatment, which may be explained by the
Although the study is uncontrolled and conducted in the focussed spot‑freeze therapy that the product delivers with
Indian population only and the sample size is relatively short treatment duration and a stable freezing temperature.
small (specific regulatory post‑marketing requirement), The findings of this study demonstrating its effectiveness
the findings of the study endorse the safety of the together with the ease of use of the product support its
investigational product and its efficacy in the treatment added value in the currently available armamentarium of
of cutaneous lesions. cryosurgical devices.
Conclusion Acknowledgments
The study demonstrated that the treatment of various The authors would like to thank M/s Bibawo India
superficial skin lesions with the study product (portable Private Limited for HYDROZID® samples for the study

430 Indian Journal of Dermatology | Volume 69 | Issue 6 | November-December 2024

 Bangaru, et al.: Portable cryosurgery device - Indian experience

and Biosphere Clinical Research Private Limited for the A review of the literature. Int J Sports Med 2017;38:1049‑60.
study management and statistical analysis. The authors 12. Bleakley CM, Bieuzen F, Davison GW, Costello JT. Whole‑body
acknowledge Dr. Manjusha Rajarshi, Regulus Healthcare, cryotherapy: Empirical evidence and theoretical perspectives.
Open Access J Sports Med 2014;5:25‑36.
Mumbai for the preparation of this manuscript.
13. Abramovits W, Graham GF, Har‑Shai Y, Strumia R.
Financial support and sponsorship Dermatological cryosurgery and cryotherapy. Anticancer Res
2016;36:4979‑80.
The Hydrozid samples were provided to the investigators
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14. Allan R, Malone J, Alexander J, Vorajee S, Ihsan M, Gregson W,

by Bibawo India. It is mentioned in the acknowledgment.
et al. Cold for centuries: A brief history of cryotherapies to
Biosphere Clinical Research organisation received fees for improve health, injury and post‑exercise recovery. Eur J Appl
carrying out the study related operations in India. Physiol 2022;122:1153‑62.
15. Rosen R, Marmur E, Anderson L, Welburn P, Katsamas J.
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A new, objective, quantitative scale for measuring local skin

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ingenol mebutate. Dermatol Ther (Heidelb) 2014;4:207‑19.
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