Use of Botulinum Toxin in Treating Rosacea: A Systematic Review

Figures & data

Table 1 List of Studies Included in the Review

Author, Year	Study Design	Number of Participants and Subtype of Rosacea	Commercial Forms	Dilution and Dosing	Outcome Measurement	Findings	Side Effects	Follow-Up	Risk of Bias	Level of Evidence
Steven H. Dayan and et al 2012	Retrospective, case series	13; not mentioned	OnabotulinumtoxinA	7 cc of saline solution per 100 U; 8 to 12 units per affected cheek area	Symptoms of erythema and flushing	Decreased flushing, erythema, and inflammation noted within one week and persisted for up to three months	No	Three months	Low	Level 4
Bloom et al 2015	Prospective, proof-of-concept noncontrolled single-center pilot study	25; erythematotelangiectatic rosacea	AbobotulinumtoxinA	Each 300 U reconstituted with 3 mL of bacteriostatic 0.9% sodium chloride; 15 to 45 units to the affected areas	A standardized grading system	Statistically significant improvement in erythema grade at 1, 2, and 3 months after treatment when compared with baseline	Transitory minimal discomfort at the injection site	Three months	Moderate	Level 4
Park et al 2015	Retrospective, case series	2; not mentioned	OnabotulinumtoxinA	50 U of Clostridium botulinum toxin type A with human serum albumin and sodium chloride reconstituted with 2.5 mL of sterile saline to achieve a concentration of 2 U/0.1 mL; 50 U in two treatments	Cosmetic result evaluation	Improvement of the lesions	Mild pain and localized bruising	Three months	Low	Level 4
Dayan et al 2017	Prospective, pilot, double-blind, placebo-controlled study (RCT)	9; erythematelangiectactic or papulopustular rosacea	IncobotulinumtoxinA	Reconstituted at 100 U/7 mL; a total of up to 20U across both checks	Rosacea Clinical Scorecard (RCS) for determining rosacea symptoms, State Self-Esteem Scale (SSES) questionnaire for assessing subjects’ self-esteem, and a 4-point categorical scale for determining subjects’ satisfaction with treatment	Alleviation of clinical manifestations of rosacea and display of higher satisfaction scores	No	20 weeks	Moderate	Level 2
Park et al 2018	Prospective, pilot study	20; erythematotelangiectatic rosacea	OnabotulinumtoxinA	50 U of Clostridium BTX type A with human serum albumin and sodium chloride reconstituted with 2.5 mL of sterile saline to achieve a concentration of 2 U/0.1 mL; 20 units for each patient	A non-treating investigator on a 4-point scale for evaluationg the severity of erythema and telangiectasia, mexameter MX18 assessment for checking the erythema index, mexameter MX18 assessment for evaluating patient satisfaction	Significant reduction of erythema severity and erythema index; a satisfaction score of 2.94±0.56 at 8 weeks after treatment	Mild facial muscle paralysis resolved without any special treatment;mild pain and bruising	8 weeks	Moderate	Level 4
Bharti et al 2018	Retrospective, case report	1; not mentioned	Not mentioned	10 units/mL; 0.05 mL microdroplet for each injection	Vascular signs and symptoms of rosacea; dermoscopy	Significant reduction in erythema, edema, telangiectasias, and flushing within 1–2 weeks; improvement in remaining papulopustular lesions and reduction in pore-size within 2 weeks	Not mentioned	4 months	High	Level 4
Kim et al 2019	Prospective, randomized, double-blind, split-face clinical study (RCT)	24; erythematotelangiectatic rosacea	PrabotulinumtoxinA	Botulinum toxin diluted with injectable NS to a concentration of 1 U per 0.1 mL; 15 U of BTX injected into one cheek	Clinician Erythema Assessment (CEA) score, Global Aesthetic Improvement Scale (GAIS) score, skin hydration, transepidermal water loss (TEWL), melanin content, erythema index, elasticity, and sebum secretions evaluated at baseline and 2, 4, 8, and 12 weeks	Significant decrease in the CEA score and significant increase in the GAIS score. Decrease in the erythema index at Weeks 4 and 8. Improvement in skin elasticity at Weeks 2 and 4 and skin hydration at Weeks 2, 4, and 8. No significant differences in TEWL and sebum secretion	Mild erythema after the injections; tolerable pain during the injections	12 weeks	High	Level 2
Friedman et al 2019	Retrospective; case series	16; erythematotelangiectatic or papulopustular rosacea	AbobotulinumtoxinA	100 U of abobotulinumtoxin A in 3 mL of bacteriostatic saline; 100 U	Mexameter, the Clinicians Erythema Assessment (CEA), Patients self-assessment (PSA)scores and the dermatology life quality index (DLQI)	Significant improvement in the average Maxameter, CEA, and PSA scores at 1, 3, and 6 months compared with baseline. Significant improvement in DLQI scores. High self-rated patient satisfaction	Self limited transient erythema, edema, mild discomfort, and pinpointed micro crusts	6 months	Low	Level 4
Al-Niaimi et al 2020	Prospective, pilot study	20; predominantly erythematotelangiectatic rosacea	AbobotulinumtoxinA or onabotulinumtoxinA	AbobotulinumtoxinA: 5 mL dilution of 500 units, 20 to 50 units per cheek; onabotulinumtoxinA: 2.5 mL dilution in 100 units, 10 to 20 units per cheek	Standardized photographs taken and erythema quantification measured using Antera 3D camera; erythema and flushing severity scores measured based on the Clinician’s Erythema Assessment Grading Scale	Synergistic benefit from combining pulsed dye laser with botulinum toxin type-A injections; reduction in both erythema and flushing grading scores; drop in erythema index measurement using 3D camera analysis.	Mild purpura	9 months	Moderate	Level 4

Figure 1 Study flow diagram.