Sclerotherapy in Pyogenic Granuloma: An Open Uncontrolled Trial
How to cite this article: Mayakuntla B, Susmitha M, Ravi SS, Bonthu I, Anitha V, Satyanarayana VV. Sclerotherapy in pyogenic granuloma: An open uncontrolled trial. Indian J Postgrad Dermatol, doi: 10.25259/ IJPGD_2_2023
Pyogenic granuloma (PG) is a common, benign lesion of vascular origin. It may rapidly grow in response to an unknown stimulus that triggers endothelial proliferation. The treatment of PG using sclerosing agents is a novel approach to overcome drawbacks associated with other procedures. The crucial purpose of this study is to evaluate the efficacy and safety of detergent sclerosant, sodium tetradecyl sulphate (STS) in the management of PG.
Materials and Methods:
A total of 18 patients with PG, attending dermatology venereology and leprosy (DVL) outpatient department (OPD) were treated with sclerotherapy after obtaining written and informed consent. STS solution (3%, 30 mg/mL) was injected with insulin syringe slowly into the lesion until the lesion blanched up to maximum amount of 0.3 mL. Injection was repeated every week until resolution or up to maximum of 4 doses. Follow-up evaluation was performed monthly, up to 3 months.
In our study, complete resolution was seen in all the patients. No complication occurred after injection. All the patients were followed up for 3 months and none of the lesions recurred over this duration.
Sclerotherapy is effective and safe in the treatment of PG without any recurrence. This approach may become a first-line therapy option for PG, especially in cases of recurrent PG associated with bleeding, and in lesions over surgically inaccessible areas.
Sodium tetradecyl sulphate
Pyogenic granuloma (PG) or lobular capillary hemangioma is a benign vascular tumor of the skin and mucous membrane. Clinically, the lesions appear as solitary red or purple nodule, characterized by rapid growth and friable surface with a tendency to bleed. Treatment modalities for PG range from surgical excision to intralesional injections of sclerosing agents. Sclerotherapy is defined as the targeted elimination of small vessels and vascular anomalies by the injection of a sclerosant. They can be broadly classified into detergents, osmotic agents, and chemical irritants. Since the lesions are reactive hyperplasias, standard therapies such as conventional surgical resection or laser surgical removal have limited therapeutic efficacy and are linked with significant recurrence rates. As a result, sclerotherapy has emerged as a feasible alternative treatment option. We attempted a sclerotherapy procedure on PG because of its vascularity and the potential response to similar other lesions.
This study includes 18 patients of PG treated with sodium tetradecyl sulphate (STS) solution (Setrol) (3%, 30 mg/ mL). Only limited studies are available in the literature, documenting the use of sclerotherapy for this indication, narrowing the knowledge gap.
MATERIAL AND METHODS
The present study was a prospective interventional study carried out from January 2021 to March 2022 in the outpatient department of dermatology in a tertiary care center after approval from the institutional ethics committee. The study enrolled 18 patients who were clinically diagnosed with PG after obtaining written informed consent. Demographic and clinical information, including the size and site of PG, was recorded. Photographic records were made before treatment (at baseline) and at each subsequent visit. No other treatment for PG was allowed for concurrent use. Pregnant and lactating women, patients with cardiac disorders, patients with any allergy to sclerosant, and who have received treatment for PG during the last 6 months were excluded from the study.
Treatment protocol and outcome evaluation
Depending on the size of the lesion, the patients received 0.1–0.3 mL of intralesional STS in the concentration of 3%, 30 mg/mL until the lesion blanches. For pedunculated lesions, the base of the lesion was clamped and the lesion was compressed with cotton gauze for about a minute to prevent sclerosant from inadvertently leaking into the surrounding tissue. The procedure was repeated every week until complete resolution or up to a total of four sessions. At each visit, the lesions were photographed and compared with the previous photographs. The lesion was monitored at least once a week after each session until it turned into a dry necrotic mass and fell off on its own. The evaluation was repeated monthly for up to 3 months.
Dermoscopy was performed in all cases before intervention and after the lesions had completely resolved. The lesions were visualized with a Dermlite DL4 dermoscope, and the photographs were taken using an iPhone 13.
Documentation of adverse effects was done, and patients were monitored on a monthly basis for 3 months following the final injection for detection of any recurrence.
The study was successfully completed by all 18 patients. Males outnumbered females in a ratio of 1.25:1. The ages of the individuals spanned between 20 and 45 years old, with a mean age 32.8 ± 7.16 years [Table 1].
|Sex||Age||Site||Diameter (mm)||Dose||No. of sessions||Complications||Response|
|Male||37||Scalp||10||0.3||2||None||Complete resolution seen|
|Female||28||Scalp||9||0.2||2||None||Complete resolution seen|
|Male||25||Hand||8||0.2||2||None||Complete resolution seen|
|Female||32||Scalp||12||0.3||3||None||Complete resolution seen|
|Male||20||Face||8||0.2||2||None||Complete resolution seen|
|Male||35||Hand||7||0.1||1||None||Complete resolution seen|
|Female||22||Scalp||13||0.3||4||None||Complete resolution seen|
|Female||37||Scalp||9||0.2||2||None||Complete resolution seen|
|Male||34||Face||7||0.1||2||None||Complete resolution seen|
|Male||27||Scalp||8||0.2||2||None||Complete resolution seen|
|Female||41||Face||6||0.1||1||None||Complete resolution seen|
|Male||45||Scalp||15||0.3||4||None||Complete resolution seen|
|Female||35||Lip||6||0.1||1||None||Complete resolution seen|
|Male||38||Scalp||12||0.3||4||None||Complete resolution seen|
|Female||26||Hand||8||0.2||2||None||Complete resolution seen|
|Male||34||Scalp||8||0.2||2||None||Complete resolution seen|
|Male||42||Scalp||11||0.3||3||None||Complete resolution seen|
|Female||25||Lip||5||0.1||1||None||Complete resolution seen|
These 15 PGs ranged in size from 0.5 to 1.5 cm (mean size: 0.9 ± 0.26 cm). The majority of the cases had lesions over the scalp (ten cases) [Figures 1-3], followed by three cases each involving lesions on the face and hand [Figure 4] and two cases with lesions over the lips. By the end of the study period (4 weeks, 4 doses of injection), all 18 (100%) patients had complete resolution of lesions. Four patients with lesion diameter <7 mm had complete resolution with a single injection of intralesional sclerotherapy by the end of 1 week. By the end of the 2nd week, nine more patients had complete clearance of lesions. Two patients with lesion diameter of 11 mm and 12 mm required 3 doses of intralesional sclerotherapy given 1 week apart for complete clearance of lesions. By the end of the 4th week, two more patients had complete clearance of lesions. Following injection, several individuals developed necrotic tissue formation, which eventually desquamated and left a normal skin surface.
One to four weekly intralesional injections were required to obtain complete remission [Table 1]. Despite statistical analysis, no link was found between characteristics such as age, gender, lesion size or location, and the number of therapy sessions/time to resolution. Dermoscopy performed using Dermlite DL4 showed red to white homogeneous areas surrounded by a collarette of scales in about 90% of the study patients [Figure 1b].
In our study (n = 18), all patients (100%) complained of pain during injection. Necrotic tissue formation following injection was noted in 18 patients (100%), mild local pruritis was seen in 10 patients (55.55%), and edema in 2 patients (11.11%). No significant complications were noted during the study period. All patients completed the 3-month follow-up period. None of the lesions recurred over this duration.
PG is a benign vascular tumor of the skin and mucous membrane characterized by rapid growth and a friable surface. It can occur at any age, but is more often seen in children and young adults. Although spontaneous regression may be seen in some cases, treatment is usually required due to frequent bleeding and ulceration.
Many surgical and non-surgical treatment modalities have been described in the management of PG. These include surgical treatments such as full-thickness excision, shave excision, cryotherapy, laser therapy, curettage, and non-surgical modalities that is, topical therapy and intralesional therapy. Conventional surgical modalities are associated with scar formation along with a high recurrence rate. As a result, sclerotherapy has emerged as a novel therapeutic modality in the treatment of PG.
Sclerotherapy is defined as the targeted elimination of small vessels and vascular anomalies by the injection of a sclerosant. They can be classified as detergents (STS, sodium morrhuate, polidocanol, and ethanolamine oleate), osmotic agents (hypertonic sodium chloride and hypertonic sodium chloride with dextrose), and chemical irritants (chromated glycerin and poly iodinated iodine). In our study, STS was considered as it is an FDA-approved detergent sclerosant for superficial varicosities as well as due to its easy availability and cost-effectiveness. Furthermore, even if it extravasates, it has a very low incidence of allergic responses, pigmentation, and other undesirable cutaneous consequences.
STS is a long-chain fatty acid that acts by causing irreversible endothelial injury, leading to inflammation and vascular thrombosis that eventually leads to the formation of fibrous tissue. Thus, when sclerosing agents are injected into the blood vessels, it causes significant tissue irritation resulting in endo fibrosis and vascular obliteration. This mechanism of action allows intralesional STS to be utilized in the treatment of PG, caused due to localized proliferation of capillaries, thereby eliminating the chance of recurrence.
Adverse effects of treatment with STS include cutaneous necrosis, hyperpigmentation, post-procedure pain, and edema. Post-procedure edema and scarring could occur secondary to an inflammatory reaction. This can be reduced by using cold packs during and immediately after the surgery. Hyperpigmentation has been reported in up to 30% of cases of spider telangiectasias treated with this agent but was not noted in any of our subjects. Other potential local complications, such as Nicolau syndrome, can occur as a result of unintended extravasation of a sclerosant into the surrounding tissue, this can be avoided by clamping the stalk of the pedunculated lesion, which was followed in our patients.
In the present case series, a 100% response rate was achieved with no recurrence. In the study done by Bansal et al. in the treatment of PG with intralesional sclerotherapy, all patients completed the study. All 15 subjects showed complete resolution of PG by the end of the 3 weeks and follow-up evaluation was performed monthly, for up to 6 months. In the study done by Moon et al., 14 cases treated with the same sclerosant showed results comparable to our study. Sacchidanand and Purohit and Moon et al. reported a complete resolution of PG in a week, using the same sclerosant in the same concentration and amount in three patients, two with PG over the lip and one over the scalp, without any recurrence during the 3-month follow-up period. In the study conducted by Shah and Ranghani, on sclerotherapy in PG and mucocele, all 15 patients showed complete regression of the lesion after 1–3 consecutive injections in a weekly interval. Recurrence was seen in a single case of mucocele.
Dermoscopically, PG is characterized by homogeneous reddish or white-red areas encircled by a whitish collarette of scale. These areas correspond to the histologic finding of proliferating capillaries and veins, while the collarette relates to the epidermal collarette that frequently surrounds the proliferation of blood vessels in the PG. White lines correspond to the histologic evidence of fibrous septa that surround the lobules.[9,10]
Limitations of the study
The major drawback of our study was the lack of a control group, besides the small sample size (n = 18) and a short follow-up period of up to 3 months, thus the rate of recurrence could not be thoroughly explored. Hence, well-designed, large randomized placebo-controlled studies with a longer follow-up time are needed to further investigate the effectiveness of intralesional STS for the therapeutic cure of PG.
We conclude that sclerotherapy is a simple, safer, effective, and inexpensive office-based technique that has a higher success rate and lowers the chances of recurrences than conventional methods. The advantages of this procedure include no necessity for local anesthesia, minimal discomfort while injecting to the patient, negligible blood loss, and no special post-operative care. The patient can immediately resume his normal activities. This innovative technique has the potential to become a first-line therapeutic option, particularly in cases of recurrent PG associated with bleeding, and also in lesions over surgically inaccessible areas. Although our study is limited by its small sample size and lack of randomization, the results are encouraging. To confirm the efficacy of intralesional STS injection for the treatment of PG in clinical practice, well-designed, large randomized placebo-controlled studies are essential in the future.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent.
Conflicts of interest
There are no conflicts of interest.
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