Lasers in Surgery and Medicine 47:173–179 (2015)
Efficacy and Safety of Laser Therapy on Axillary Hyperhidrosis After One Year Follow-Up: A Randomized Blinded Controlled Trial Franck Marie Lecle`re, MD, PhD,1,2,3 Javier Moreno-Moraga, MD, PhD,4 Justo M. Alcolea, MD,5 Peter M. Vogt, MD, PhD,3 Josefina Royo, MD,4 Paloma Cornejo, MD,4 Vincent Casoli, MD, PhD,1 Serge Mordon, PhD,2 and Mario A. Trelles, MD, PhD5 1 Department Plastic-, Hand-, Burn-, and Transsexual Surgery, CHU University of Bordeaux, Bordeaux, France 2 INSERM U703, CHU Lille, Lille, France 3 Department of Plastic Surgery MHH, Hannover Medical School, Hannover, Germany 4 Instituto M edico La´ser, Madrid, Spain 5 Instituto M edico Vilafortuny, FUNDACION ANTONI DE GIMBERNAT, Cambrils, Tarragona
Introduction: Hyperhidrosis is a debilitating problem that is not only uncomfortable and inconvenient, but also embarrassing in work and social situations. In spite of the availability of several options for the treatment of axillary hyperhidrosis, recently, there has been an increasing interest in the use of laser therapy. This study aims to evaluate the efficacy of a laser diode device emitting at wavelengths of 924 and 975 nm and classical curettage either alone, simultaneously or in combination. Material and methods: A randomized prospective controlled trial was carried out on 100 patients divided into four groups, each with a different protocol: Laser alone at 975 nm (group 1), laser alone at 924/975 nm simultaneously (group 2), curettage alone (group 3), and finally laser at 924/975 nm followed by curettage (group 4). HDSS, starch test and GAIS were used to assess treatment efficacy. The follow-up extended to one year. Statistical analysis (SPSS) was used to determine the accuracy of the results. Result: : Two patients of group 1 experienced burns during treatment, which took over a month to heal. This group of patients achieved the worst results: The starch test scale results after treatment were 2.48 0.51 and 2.76 0.44 (at 1 and 12 months). The GAIS results were 1.04 0.35 and 0.92 0.28 (1 and 12 months). In group 2 the starch test scale results after treatment were 1.36 0.49 and 1.48 0.51 (at 1 and 12 months). The GAIS results were 2.36 0.49 and 2.72 0.46 (at 1 and 12 months). In group 3, the starch test scale results after treatment were 1.56 0.51 and 1.76 0.60 (at 1 and 12 months), which corresponds to small to substantially smaller dark areas. The GAIS results were 2.28 0.46 and 2.64 0.49 (at 1 and 12 months). The best results were obtained in group 4: HDSS scores were reduced from 3.88 0.33 before treatment to 1.24 0.44 and 0.48 0.51 at the 1 and 12 months controls. The starch test scale results after treatment were 0.40 0.50 and 0.44 0.51 (at 1 and 12 months). The GAIS results were 3.72 0.54 and 3.76 0.44 (at 1 and 12 months). ß 2015 Wiley Periodicals, Inc.
Conclusion: : In this study, the laser at 924/975 nm combined with curettage was determined to be the optimal treatment option of those tested for axillary hyperhidrosis. This treatment was safe, with few side effects and improvement that persisted to one year follow-up. Lasers Surg. Med. 47:173–179, 2015. ß 2015 Wiley Periodicals, Inc. Key words: axillary hyperhidrosis; diode laser; Curettage
INTRODUCTION
Primary hyperhidrosis is a common disorder affecting 2.8% of the US population [1]. Although not life threatening, hyperhidrosis has been shown to have a significant negative impact on a person’s quality of life [2]. There are several options available for the treatment of axillary hyperhidrosis [3]. Non-surgical interventions include topical aluminum salts and Botulinum Toxin A injections [4,5]. Surgical treatments include full-thickness skin excision, thoracic sympathectomy [6,7] and subcutaneous suction-curettage [8,9]. Recently, there has been an increasing interest in laser therapy to treat axillary hyperhidrosis (LATAH) [9–12]. Most authors have used Nd:YAG lasers emitting at 1064 and 1320 nm [7]. According to the literature and our own experience,
Franck Marie Lecle`re and Javier Moreno-Moraga contributed equally to this paper. Conflict of Interest Disclosures: Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. Correspondence to: Mario A. Trelles, MD, PhD. Instituto M edico Vilafortuny. Avda. Vilafortuny, 31. E43850 Cambrils. Tarragona. Spain. E-mail: [email protected] Accepted 20 November 2014 Published online 6 February 2015 in Wiley Online Library (wileyonlinelibrary.com). DOI 10.1002/lsm.22324
174
` RE ET AL. LECLE
LATAH presents the following advantages over conventional therapy: It is a (i) minimally invasive [13] and (ii) safe therapy [14], (iii) which offers a permanent solution. Despite the numerous studies on LATAH, there is still a lack of comparative controlled studies in literature. In this study, we comparatively examine the effectiveness of a diode-powered laser using two different wavelengths, 924 and 975 nm, either alone or in combination with the classical curettage method, which was also used alone. The aim was also objectively and subjectively to quantify whether any of these treatments differed in their outcome scores at one year follow up. MATERIAL AND METHODS Patients The clinical study protocol was reviewed and approved by our ethics committee. Inclusion criteria were: patients suffering from hyperhidrosis, with an HDSS score of 3–4 and a starch test with an area larger than 6 12 cm. Exclusion criteria were: active or chronic skin disease, inflammation or other symptoms (cancerous or precancerous lesions) on the underarms or neighboring areas, previous treatment with sympathectomy at any time and/or botulinum toxin type A during the 12 months prior to beginning the study, treatment with anticoagulants or coagulation disorders, use of Acetylsalicylic Acid during the week prior to treatment, history of severe anaphylactic reactions, previous formation of keloids or hypertrophic scars, and previous allergic reaction to lidocaine. Pregnancy and breastfeeding were also criteria for exclusion. All patients agreed to forego any other axillary hyperhidrosis treatment during the study. Patients were randomly assigned to one of the following groups: Group 1-Laser alone emitting at 975 nm; Group 2-Laser alone emitting at 924/975 nm simultaneously; Group 3: Curettage alone; Group 4-Laser emitting at 924/975 nm and curettage, used in the same procedure. One hundred and two patients completed this study, 25 in the first group, 26 in the second group, 26 in the third group and 25 in the fourth group. One patient from each of groups 2 and 3 were randomly omitted, thus obtaining four groups of 25 patients each. All patients were randomized to the different treatment groups. Degree of hyperhidrosis and complaints were similar in all groups. Hyperhidrosis The first visit prior to surgery involved a general information interview, an assessment of the degree of sweating by performing HDSS (Table 1) and starch test (Table 2) and a process of informed consent. The hyperhidrosis disease severity scale (HDSS) was used for diagnosis of each patient. The same scale was also used after treatment to evaluate the results. Laser Parameters The 924 and 975 nm diode laser system used in this study consists of two lasers, one emitting at 924 nm and the other one at 975 nm, built into the same console (Aspire SlimLipo
TABLE 1. Definition of Hyperhidrosis Disease Severity Scale (HDSS) A 5-Point, Single-Item Question No sweat (never noticeable) Never noticeable, never interferes Tolerable, sometime interferes Barely tolerable, frequently interferes Intolerable and always interferes
PalomarTM, Burlington, MA). Lasers can be used individually or simultaneously. They can also be controlled independently in continuous-wave mode at a chosen power level until reaching the total accumulative energy desired per underarm treated. The following laser parameters were used: 1.5 mm diameter/27 cm cannula, continuous emission at 20 W power of both laser emissions for groups 2 and 4 and only the 975 nm laser emission for group 1. Temperature was externally controlled in the treatment area by using an infrared thermometer (CEM DT-880B, Shenzhen Everbest Machinery Industry Co. Ltd, China). Surgical Technique In the supine position, the patient’s torso and upper extremities were cleaned and draped in the usual surgical sterile manner. The hair-bearing region of each axilla was marked with a sterile surgical pen; a prior starch test indicated the optimal treatment area. The anaesthetic technique was the the same in the four groups: 1% lidocaine was injected and a 2 mm disposable skin punch was used to form between one and three entry points for the cannula. Sterile surgical lubricant (Vaselina Pura Cuve Perez-Gimenez, Spain) was applied to the entry point sites to reduce cannula friction. A tumescent solution consisting of 0.1% lidocaine, 1:1000 epinephrine and 10 mEq/l sodium bicarbonate was infiltrated in the subcutaneous plane with a blunt-tipped, small-diameter infusion cannula, extending 2 cm beyond the marked area. Approximately 150–200 ml (1.5–2.0 mg) of lidocaine of tumescent fluid was administered to each axilla for optimal anaesthesia and vasoconstriction. Group 1. After 15 minutes, a Toledo round-tipped disruption cannula (2 mm diameter, 24 cm long) was passed to-and-fro in a fanning motion without suction to mechanically separate the subcutaneous layer from the dermis, creating a plane in which to perform the subdermal laser treatment. The 1.5 mm diameter laser optical fibre was introduced without the cannula into the subdermal plane, allowing energy to be directly transmitted to the underside of the dermis. Laser energy was provided by
TABLE 2. Definition of Starch-Iodine Scale Improvement. A 4-point, Single-Item Size (3) (2) (1) (0)
Big dark area without changes evidence Smaller dark area than before Very smaller dark area than before No evidence of sweating area by Starch test
(>6 cm) (6–2 cm) (
Efficacy and Safety of Laser Therapy on Axillary Hyperhidrosis After One Year Follow-Up: A Randomized Blinded Controlled Trial Franck Marie Lecle`re, MD, PhD,1,2,3 Javier Moreno-Moraga, MD, PhD,4 Justo M. Alcolea, MD,5 Peter M. Vogt, MD, PhD,3 Josefina Royo, MD,4 Paloma Cornejo, MD,4 Vincent Casoli, MD, PhD,1 Serge Mordon, PhD,2 and Mario A. Trelles, MD, PhD5 1 Department Plastic-, Hand-, Burn-, and Transsexual Surgery, CHU University of Bordeaux, Bordeaux, France 2 INSERM U703, CHU Lille, Lille, France 3 Department of Plastic Surgery MHH, Hannover Medical School, Hannover, Germany 4 Instituto M edico La´ser, Madrid, Spain 5 Instituto M edico Vilafortuny, FUNDACION ANTONI DE GIMBERNAT, Cambrils, Tarragona
Introduction: Hyperhidrosis is a debilitating problem that is not only uncomfortable and inconvenient, but also embarrassing in work and social situations. In spite of the availability of several options for the treatment of axillary hyperhidrosis, recently, there has been an increasing interest in the use of laser therapy. This study aims to evaluate the efficacy of a laser diode device emitting at wavelengths of 924 and 975 nm and classical curettage either alone, simultaneously or in combination. Material and methods: A randomized prospective controlled trial was carried out on 100 patients divided into four groups, each with a different protocol: Laser alone at 975 nm (group 1), laser alone at 924/975 nm simultaneously (group 2), curettage alone (group 3), and finally laser at 924/975 nm followed by curettage (group 4). HDSS, starch test and GAIS were used to assess treatment efficacy. The follow-up extended to one year. Statistical analysis (SPSS) was used to determine the accuracy of the results. Result: : Two patients of group 1 experienced burns during treatment, which took over a month to heal. This group of patients achieved the worst results: The starch test scale results after treatment were 2.48 0.51 and 2.76 0.44 (at 1 and 12 months). The GAIS results were 1.04 0.35 and 0.92 0.28 (1 and 12 months). In group 2 the starch test scale results after treatment were 1.36 0.49 and 1.48 0.51 (at 1 and 12 months). The GAIS results were 2.36 0.49 and 2.72 0.46 (at 1 and 12 months). In group 3, the starch test scale results after treatment were 1.56 0.51 and 1.76 0.60 (at 1 and 12 months), which corresponds to small to substantially smaller dark areas. The GAIS results were 2.28 0.46 and 2.64 0.49 (at 1 and 12 months). The best results were obtained in group 4: HDSS scores were reduced from 3.88 0.33 before treatment to 1.24 0.44 and 0.48 0.51 at the 1 and 12 months controls. The starch test scale results after treatment were 0.40 0.50 and 0.44 0.51 (at 1 and 12 months). The GAIS results were 3.72 0.54 and 3.76 0.44 (at 1 and 12 months). ß 2015 Wiley Periodicals, Inc.
Conclusion: : In this study, the laser at 924/975 nm combined with curettage was determined to be the optimal treatment option of those tested for axillary hyperhidrosis. This treatment was safe, with few side effects and improvement that persisted to one year follow-up. Lasers Surg. Med. 47:173–179, 2015. ß 2015 Wiley Periodicals, Inc. Key words: axillary hyperhidrosis; diode laser; Curettage
INTRODUCTION
Primary hyperhidrosis is a common disorder affecting 2.8% of the US population [1]. Although not life threatening, hyperhidrosis has been shown to have a significant negative impact on a person’s quality of life [2]. There are several options available for the treatment of axillary hyperhidrosis [3]. Non-surgical interventions include topical aluminum salts and Botulinum Toxin A injections [4,5]. Surgical treatments include full-thickness skin excision, thoracic sympathectomy [6,7] and subcutaneous suction-curettage [8,9]. Recently, there has been an increasing interest in laser therapy to treat axillary hyperhidrosis (LATAH) [9–12]. Most authors have used Nd:YAG lasers emitting at 1064 and 1320 nm [7]. According to the literature and our own experience,
Franck Marie Lecle`re and Javier Moreno-Moraga contributed equally to this paper. Conflict of Interest Disclosures: Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. Correspondence to: Mario A. Trelles, MD, PhD. Instituto M edico Vilafortuny. Avda. Vilafortuny, 31. E43850 Cambrils. Tarragona. Spain. E-mail: [email protected] Accepted 20 November 2014 Published online 6 February 2015 in Wiley Online Library (wileyonlinelibrary.com). DOI 10.1002/lsm.22324
174
` RE ET AL. LECLE
LATAH presents the following advantages over conventional therapy: It is a (i) minimally invasive [13] and (ii) safe therapy [14], (iii) which offers a permanent solution. Despite the numerous studies on LATAH, there is still a lack of comparative controlled studies in literature. In this study, we comparatively examine the effectiveness of a diode-powered laser using two different wavelengths, 924 and 975 nm, either alone or in combination with the classical curettage method, which was also used alone. The aim was also objectively and subjectively to quantify whether any of these treatments differed in their outcome scores at one year follow up. MATERIAL AND METHODS Patients The clinical study protocol was reviewed and approved by our ethics committee. Inclusion criteria were: patients suffering from hyperhidrosis, with an HDSS score of 3–4 and a starch test with an area larger than 6 12 cm. Exclusion criteria were: active or chronic skin disease, inflammation or other symptoms (cancerous or precancerous lesions) on the underarms or neighboring areas, previous treatment with sympathectomy at any time and/or botulinum toxin type A during the 12 months prior to beginning the study, treatment with anticoagulants or coagulation disorders, use of Acetylsalicylic Acid during the week prior to treatment, history of severe anaphylactic reactions, previous formation of keloids or hypertrophic scars, and previous allergic reaction to lidocaine. Pregnancy and breastfeeding were also criteria for exclusion. All patients agreed to forego any other axillary hyperhidrosis treatment during the study. Patients were randomly assigned to one of the following groups: Group 1-Laser alone emitting at 975 nm; Group 2-Laser alone emitting at 924/975 nm simultaneously; Group 3: Curettage alone; Group 4-Laser emitting at 924/975 nm and curettage, used in the same procedure. One hundred and two patients completed this study, 25 in the first group, 26 in the second group, 26 in the third group and 25 in the fourth group. One patient from each of groups 2 and 3 were randomly omitted, thus obtaining four groups of 25 patients each. All patients were randomized to the different treatment groups. Degree of hyperhidrosis and complaints were similar in all groups. Hyperhidrosis The first visit prior to surgery involved a general information interview, an assessment of the degree of sweating by performing HDSS (Table 1) and starch test (Table 2) and a process of informed consent. The hyperhidrosis disease severity scale (HDSS) was used for diagnosis of each patient. The same scale was also used after treatment to evaluate the results. Laser Parameters The 924 and 975 nm diode laser system used in this study consists of two lasers, one emitting at 924 nm and the other one at 975 nm, built into the same console (Aspire SlimLipo
TABLE 1. Definition of Hyperhidrosis Disease Severity Scale (HDSS) A 5-Point, Single-Item Question No sweat (never noticeable) Never noticeable, never interferes Tolerable, sometime interferes Barely tolerable, frequently interferes Intolerable and always interferes
PalomarTM, Burlington, MA). Lasers can be used individually or simultaneously. They can also be controlled independently in continuous-wave mode at a chosen power level until reaching the total accumulative energy desired per underarm treated. The following laser parameters were used: 1.5 mm diameter/27 cm cannula, continuous emission at 20 W power of both laser emissions for groups 2 and 4 and only the 975 nm laser emission for group 1. Temperature was externally controlled in the treatment area by using an infrared thermometer (CEM DT-880B, Shenzhen Everbest Machinery Industry Co. Ltd, China). Surgical Technique In the supine position, the patient’s torso and upper extremities were cleaned and draped in the usual surgical sterile manner. The hair-bearing region of each axilla was marked with a sterile surgical pen; a prior starch test indicated the optimal treatment area. The anaesthetic technique was the the same in the four groups: 1% lidocaine was injected and a 2 mm disposable skin punch was used to form between one and three entry points for the cannula. Sterile surgical lubricant (Vaselina Pura Cuve Perez-Gimenez, Spain) was applied to the entry point sites to reduce cannula friction. A tumescent solution consisting of 0.1% lidocaine, 1:1000 epinephrine and 10 mEq/l sodium bicarbonate was infiltrated in the subcutaneous plane with a blunt-tipped, small-diameter infusion cannula, extending 2 cm beyond the marked area. Approximately 150–200 ml (1.5–2.0 mg) of lidocaine of tumescent fluid was administered to each axilla for optimal anaesthesia and vasoconstriction. Group 1. After 15 minutes, a Toledo round-tipped disruption cannula (2 mm diameter, 24 cm long) was passed to-and-fro in a fanning motion without suction to mechanically separate the subcutaneous layer from the dermis, creating a plane in which to perform the subdermal laser treatment. The 1.5 mm diameter laser optical fibre was introduced without the cannula into the subdermal plane, allowing energy to be directly transmitted to the underside of the dermis. Laser energy was provided by
TABLE 2. Definition of Starch-Iodine Scale Improvement. A 4-point, Single-Item Size (3) (2) (1) (0)
Big dark area without changes evidence Smaller dark area than before Very smaller dark area than before No evidence of sweating area by Starch test
(>6 cm) (6–2 cm) (
