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Low level narrow band red light treatment of acne vulgaris

By Avikam Harel M.D, *Esther 0 Grunis, M.A

Rina Levarn M.D ; and Gideon Earon M.D.


acneVulgaris

 

Article Sections :
Abstract Introduction Methods Statistical Methods Results Discussion IIIustration TABLE I – Acne Grading According to Burton Scale TABLE II – Light Emitter Specification TABLE III – Groups of patients TABLE IV – Rate of Drop of Patients from Study References.


ABSTRACT
Phototherapy treatment using low intensity visible red light (laser) for wound healing is well known. However, its worldwide use is prohibitively expensive and requires a clinical setting. Using a hady, safe and inexpensive non – coherent low level narrow band red light device (LLRL), we performed a prospective clinical trail on 53 patients suffering from Acne Vulgaris. The patients were devided into five groups according to duration and mode of treatment. Two more groups werw treated combining phototherapy with medication. The results, following six weeks of LLRL treatment, showed a significant improvement in the group treated twice a day for 6 minutes by continuous wave (CW). The time reaction to the LLRL treatmentwas shortened by adding Minocycline (Minocin Lederle) 50 mg twice a day. According to theses results, LLRL alone or together with minocycline should be considered a valid and affective treatment for Acne Vulgaris.

INTRODUCTION
The bio – stimulating effects of low level laser irradiation have arroused much inerest since the pioneering work of Master in the early 1970’s (1), and werw proven in clinical as well as in Vitro studies (2), (3), (4), (5). However, it has been showen that at least some of these biological effects can be achieved by exposure to non – coherent low level red light (6). In fact, macrophages exposed to 660 nm low level wavelengths relsase factors which stimulate fibroblast proliferation and mediators of wound repair and inflammatory process healing (7), (11).

The purpose of this study was to evaluate, by a prospective clinical trial, the therapeutic effect of LLRL on the inflammatory lesion of Acne Vulgaris, and establish the optimal duration and mode of illumination.

METHODS
Fifty – three patients, age 14 to 28 years, suffering from Acne Vulgaris (grads 2 to 5 according to Burton scaie) (8). Werw selected for this study (Table 1). The patients werein good physical condition with no endocrine, metabolic, or immunological disorders. Medical evaluation at the beginning of the study and once a week thereafter was carried out by two members of the medical team separately.

An emitter of LLRL (BioBeam 660) was chosen for the treatment due to its low cost, convenient size, and safety. Its healing properties have been effective in treating wounds such as diabetic ulcers, bed sores, venous ulcers, and post – operative wounds (9). The device may be operated in two modes : continuous wave (CW), which has a maximum power density of 15 mw/cm2 with 18 mw of power at focus : and pulse wave (PW), which has a greater peak power at focus (?75 mw) with only half the average power (7.5 mw) (Table 11).

Patients were instructed by the staff and performed treatments at home. Affected areas werw Illuminated from distance of 2 em determined by a plastic ring (diameter 4 em) fitted to the device and held touching the face.
Protective goggles were worn to avoid exposure to the eyes.

Patients were divided into 5 groups according to the duration and mode of illumination (Table III). Eight patients participated in each group except Group V which had five. Patients in Groups 1, 11, and III, applied the device to the affected area twice a day, seet to modes CW and PW consecutively, for 1.5, M and 4 minutes respectively. The 1.5, 2.5 and 4 minutes correspond to total treatment time of the CW and PW modes usde together for 3,5 and 8 minutes respectively. It became evident that longer exposure to the CW mode provided greater improvement.Therefore, Groups IV and V used only the CW mode for 6 and 8 minutes respectively on each affected area.

Two more groups of patients combined LLRL with medication to determine whether it could enhance the therapeutic effects of exposure to LLRL. One group was treated with contraceptive pills containing cyproterone acetate 2 mg and ethinylestradiol 0.035 mg (Diana – 35 Schering Germany).and the other with minocycline 50 mg (Minocin, Lederle) twice a day.

The results of eleven patients, mostly from Groups 1 and II who did not complete the 6 weeks of treatment were included in the study up to the time they stopped treatment.

STATISTICAL METHODS
The effectiveness of the treatment was measurd by the change in the Burton Scale from the pre- treatment level. (Anegative value implies worsening of the clinical feature).

Differences between groups were analyzed using Anova and Tukey’s method for pairuse comparisons. They were supplemented by the Kruski – Wallis test where appropriate.

RESULTS
The effectiveness of the 6 – minute treatment alone and combined with medication is presents in Figure 1. All three versions exhibit continuous improvement as treatment progressed. By the end of the sixth week, the mean (±SE) improvement achieved by illumation was 1.92 (±2) change on the Burton scale, with minocin 2.6 (±2) and with Diane – 35 (±3).
The differences between the three groups are statistically singnificant :
P.001 using Kroskal – Wallis test when judged together. The difference between illumation alone and the minocin group is not significant, while the differences of theses two groups to the Diane – 35 group are significant (p.0.5 using Tukey’s method). The differences between the three groups presented in Figure 1 werw already significant by the third week (p.012). Note that the rate of improvement was the slowest when illumation was supplemented by Diane –35, and fastest when supplemented by minocin. No significant differences were noted between the 6 and 8 minute groups. There is no statistical analysis available for those patient who dropped out due to lack of compllance.
The effectiveness of the illumination at lower duration is presented in
Figure 2. The trends show enhanced effectivnese with Increased duration. The full analysis of this data is not feasible because of the large percentage of subjects who dropped out during the study. The rate of drup – outs (Table IV) increased when the therapeutic effect was not evident (Group 1,2) and when the illumination period was too long ( Group V).

We do use statistical analysis of the third week where only one subject was missing. For the 1.5 minute group there was a mean “improvement” of –.5 ; the 2112 minute group – A; and the four minute group +25. these differences, though cometible with the general trand, were not statistically significant (P=137).They are all lower then the 44 mean improvement for the 6 minute group for week 3.

DISCUSSION
Karu, in her study dealing with the bio – stimulation effect of laser irradation, suggests that coherence was not always essential for bio – stimulation (10). In effect, in vitro irradation of macrophage cell culture with none – coherent light at specific wavelengths has been proven to modify their ability to effect fibroblast proliferation (11). The type and degree of modification was found to be dependent upon the wavelengths used. Irradeation with none - coherent light at a wavelength of660 nm has been shown to produce the maximum stimulatory effect on fibroblast proliferation. It was proposed that non – coherent light may effect macrophage behavior in part via their effect on the permeability of the cell membrane to calcium lons (12). In fact, calcium intake was also shown to be wavelengths, depended and 660 nm was the most effective of the wavellengths tested.

As an emitter of non – coherent narrow band red light. We use a safe, low cost device (BioBeam 660) that is widely used in our clinics to treat various wounds such as bed sores, diabetic ulcers, venous ulcers and post – operative wounds. The instrument used deserves special attention. Most of the low level laser instrument deliver an energy of 20 mw concentrated in an area of few square millmeters and result in a power density of 500 to 2000 mw/cm2 (13,14). The BioBeam 660, however, has a power density of only 15 mw/cm2 i.e, it does not exceed 1/3 the power density of sunlight at noon (approximately 60 mw/cm2). This difference in favor of the BioBeam 660 provides an added saftey dimension for the patient.

The aim of the study was twofold : to evaluate the effect of narrow band red light on inflammatory conditions such as Acne Vulgaris, and to establish criteria for the optimal use of red light on such conditions.

Five groups of patients were studied using specified mode and duration of LLRL treatment. Two more groups were examind combining LLRL treatment with medication. We noted less improvement with shorter exposure, and heightened results with increased use of the CW mode. However, when we compared 6 –minute durations of exposure to the CW mode, we noted no significant difference in results. But a marked decrease in compliance. Regarding the mode treatmen, combining PW and CW modes, as was done in Groups I, II and III did not change the course of the treatment which was influenced only by the amount of time spent employing the CW mode. We thus concluded that the optimal time of treatment was 6 minutes twice a day on up to three affected areas using the CW mode.

Two other groups using combined LLRL and medication were tested. One group was treated with Diana – 35, the other with minocyclin 50 rag twice a day. The group using Diana – 35 showed an initial worsening in the condition, a characterisic of this treatment. Usually there is a two month period before definite improvement is noticed , however, by combining Diana – 35 with BioBeam, we saw signs of improvement as early as one month after initiating treatment.

When we used BioBeam with minacycline, we saw a faster improvement but the quality of the improvement was the same.

We do not conclude that LLRL alone or together with minacycline is a safe and effective treatment to be considered among the treatments of Acne.

TABLE 1 – Acne Grading According to Burton Scale

Grade 0 - Total absence of lesions
Grade I -  Sub Clinical Acne – few comedons visible only in close examination
Grade II -  Comedonal Acne – comedons with slight inflammation.
Grade III - Mild Acne – inflamed papules with erythema.
Grade IV - Moderate Acne – many inflamed papules and pustules
Grade V - Severe Nodular Acne - inflamed papulesand pustules with several deep modular lesions.
Grade VI - Severe Cystic Acne – many modular cystic lesions with scarring.

TABLE II – Light Emitter Specification
Wavelengh - 660nm 660nm
Mode of operation - cw pw
Output power (mw) - 18 75(peak)
Illuminated area (cm’) - 2 2
Power density  (mw/cm2) - 8 34
Average power (mw) - 18 7.5
Pulses per second - 100
Duty ratio (%) - 10
Pulse time (ms) - 1
Delivery energy (j/min) - 1.08 0.45
Cw= continuous wave - pw= puise wave

TABLE III – Groups of Patients
Group no. IIIumination Mode Drugs Treatments
duration per day
I.8 1.5 min cw/pw none 2
II.8 2.5 min cw/pw none 2
III.8 4 min cw/pw none 2
IV.8 6 min cw none 2
V.5 8 min cw none 2
VI.8 6 min cw Diane-35 2
VII.8 6 min cw minocin 50mg 2
x2

TABLE IV – Rate of Drop – out of Patients from Study
Week  1st 2nd 3rd 4th 5th 6th total
Group I 1 2 3
Group II 1 2 1 4
Group III 1 1
Group IV 0
Group V 2 2
Group VI 1 1
Group VII 0


REFERENCES
1.Mester , E, et. Al. Effect of laser rays on wound healing. Am. J. Surg. 1971 ;122:532-535

2.Calderhead, Glen R. Review of the Biostimulation Session of the 11th Meeting of the American Society for laser medicine and Surgery (ASLMS). Lasers in Surgery and medicine Supplement 3, 1991.

3.Mester , E, et. Al. (1985). The biomedical effects of laser application. Lasers in Surgery and Medicine 5, 31-39.

4.Master, A.F and Master A.R (1988). Scientific backround of laser biostimulation, Laser 1(1) 23.

5.Karu, T.I (1988) Molecular mechanisms of the therapeutic effect of low – intensity laser irradiation. Lasers in life sciences, 2 (1) 53-74.

6.Sasanov, A.M et. Al. Low – intensity non coherent red light in the comprehensive treatment of gastroduodenal ulcers. Soy. Med. 12,42.

7.Abergal , R.P (1987). Biostimulation of wound healing by lasers ; experimental approaches in animal models and fibroblast cultures. Journal of Dermatology and Surgical Oncology 13, 127.

8.Burton J. et. Al The Prevalence of Acne Vulgaris in Adolescence. Dr J. Dream. 119 :85,1971.

9.Lusim, M et. Al Evaluation of the Degree of Effectiveness of BioBeam (Low level narrow band light) on the treatment of skin Ulcers and Delayed Post Operative Wound Healing. Accepted for publication in Orthopeadics, 1992.

10.Karu, T.I (1987). Photobiological Fundamentals of lowpower laser therapy. Journal of Quantum Electronics 10,23.

11.Young , S. et. Al Macrophage Responsiveness to light Therapy Lasers in Surgery and Medicine. 9 : 497-505 (1989).

12.Young , S. et. Effect of light on Calcium Uptake by Macrophages Original Articals. Lasers in Surgery and Medicine. Supplement 1991 by John Wiley & Sons Ltd.

13.King , P.R (1989) Low level laser therapy ; a review. Lasers in Medical Science 4, 141 –150.

14.Rochking, S. et. al Systemic Effect of low power laser irradiation on the peripheral and central nevous system, Cutaneous Wounds, and Burns. Lasers in Surgery and Medicine 9 ;174-182 (1989).

Low level narrow band red light treatment of acne vulgaris

By Avikam Harel M.D, *Esther 0 Grunis, M.A

Rina Levarn M.D ; and Gideon Earon M.D.


acneVulgaris

 

Article Sections :
Abstract Introduction Methods Statistical Methods Results Discussion IIIustration TABLE I – Acne Grading According to Burton Scale TABLE II – Light Emitter Specification TABLE III – Groups of patients TABLE IV – Rate of Drop of Patients from Study References.


ABSTRACT
Phototherapy treatment using low intensity visible red light (laser) for wound healing is well known. However, its worldwide use is prohibitively expensive and requires a clinical setting. Using a hady, safe and inexpensive non – coherent low level narrow band red light device (LLRL), we performed a prospective clinical trail on 53 patients suffering from Acne Vulgaris. The patients were devided into five groups according to duration and mode of treatment. Two more groups werw treated combining phototherapy with medication. The results, following six weeks of LLRL treatment, showed a significant improvement in the group treated twice a day for 6 minutes by continuous wave (CW). The time reaction to the LLRL treatmentwas shortened by adding Minocycline (Minocin Lederle) 50 mg twice a day. According to theses results, LLRL alone or together with minocycline should be considered a valid and affective treatment for Acne Vulgaris.

INTRODUCTION
The bio – stimulating effects of low level laser irradiation have arroused much inerest since the pioneering work of Master in the early 1970’s (1), and werw proven in clinical as well as in Vitro studies (2), (3), (4), (5). However, it has been showen that at least some of these biological effects can be achieved by exposure to non – coherent low level red light (6). In fact, macrophages exposed to 660 nm low level wavelengths relsase factors which stimulate fibroblast proliferation and mediators of wound repair and inflammatory process healing (7), (11).

The purpose of this study was to evaluate, by a prospective clinical trial, the therapeutic effect of LLRL on the inflammatory lesion of Acne Vulgaris, and establish the optimal duration and mode of illumination.

METHODS
Fifty – three patients, age 14 to 28 years, suffering from Acne Vulgaris (grads 2 to 5 according to Burton scaie) (8). Werw selected for this study (Table 1). The patients werein good physical condition with no endocrine, metabolic, or immunological disorders. Medical evaluation at the beginning of the study and once a week thereafter was carried out by two members of the medical team separately.

An emitter of LLRL (BioBeam 660) was chosen for the treatment due to its low cost, convenient size, and safety. Its healing properties have been effective in treating wounds such as diabetic ulcers, bed sores, venous ulcers, and post – operative wounds (9). The device may be operated in two modes : continuous wave (CW), which has a maximum power density of 15 mw/cm2 with 18 mw of power at focus : and pulse wave (PW), which has a greater peak power at focus (?75 mw) with only half the average power (7.5 mw) (Table 11).

Patients were instructed by the staff and performed treatments at home. Affected areas werw Illuminated from distance of 2 em determined by a plastic ring (diameter 4 em) fitted to the device and held touching the face.
Protective goggles were worn to avoid exposure to the eyes.

Patients were divided into 5 groups according to the duration and mode of illumination (Table III). Eight patients participated in each group except Group V which had five. Patients in Groups 1, 11, and III, applied the device to the affected area twice a day, seet to modes CW and PW consecutively, for 1.5, M and 4 minutes respectively. The 1.5, 2.5 and 4 minutes correspond to total treatment time of the CW and PW modes usde together for 3,5 and 8 minutes respectively. It became evident that longer exposure to the CW mode provided greater improvement.Therefore, Groups IV and V used only the CW mode for 6 and 8 minutes respectively on each affected area.

Two more groups of patients combined LLRL with medication to determine whether it could enhance the therapeutic effects of exposure to LLRL. One group was treated with contraceptive pills containing cyproterone acetate 2 mg and ethinylestradiol 0.035 mg (Diana – 35 Schering Germany).and the other with minocycline 50 mg (Minocin, Lederle) twice a day.

The results of eleven patients, mostly from Groups 1 and II who did not complete the 6 weeks of treatment were included in the study up to the time they stopped treatment.

STATISTICAL METHODS
The effectiveness of the treatment was measurd by the change in the Burton Scale from the pre- treatment level. (Anegative value implies worsening of the clinical feature).

Differences between groups were analyzed using Anova and Tukey’s method for pairuse comparisons. They were supplemented by the Kruski – Wallis test where appropriate.

RESULTS
The effectiveness of the 6 – minute treatment alone and combined with medication is presents in Figure 1. All three versions exhibit continuous improvement as treatment progressed. By the end of the sixth week, the mean (±SE) improvement achieved by illumation was 1.92 (±2) change on the Burton scale, with minocin 2.6 (±2) and with Diane – 35 (±3).
The differences between the three groups are statistically singnificant :
P.001 using Kroskal – Wallis test when judged together. The difference between illumation alone and the minocin group is not significant, while the differences of theses two groups to the Diane – 35 group are significant (p.0.5 using Tukey’s method). The differences between the three groups presented in Figure 1 werw already significant by the third week (p.012). Note that the rate of improvement was the slowest when illumation was supplemented by Diane –35, and fastest when supplemented by minocin. No significant differences were noted between the 6 and 8 minute groups. There is no statistical analysis available for those patient who dropped out due to lack of compllance.
The effectiveness of the illumination at lower duration is presented in
Figure 2. The trends show enhanced effectivnese with Increased duration. The full analysis of this data is not feasible because of the large percentage of subjects who dropped out during the study. The rate of drup – outs (Table IV) increased when the therapeutic effect was not evident (Group 1,2) and when the illumination period was too long ( Group V).

We do use statistical analysis of the third week where only one subject was missing. For the 1.5 minute group there was a mean “improvement” of –.5 ; the 2112 minute group – A; and the four minute group +25. these differences, though cometible with the general trand, were not statistically significant (P=137).They are all lower then the 44 mean improvement for the 6 minute group for week 3.

DISCUSSION
Karu, in her study dealing with the bio – stimulation effect of laser irradation, suggests that coherence was not always essential for bio – stimulation (10). In effect, in vitro irradation of macrophage cell culture with none – coherent light at specific wavelengths has been proven to modify their ability to effect fibroblast proliferation (11). The type and degree of modification was found to be dependent upon the wavelengths used. Irradeation with none - coherent light at a wavelength of660 nm has been shown to produce the maximum stimulatory effect on fibroblast proliferation. It was proposed that non – coherent light may effect macrophage behavior in part via their effect on the permeability of the cell membrane to calcium lons (12). In fact, calcium intake was also shown to be wavelengths, depended and 660 nm was the most effective of the wavellengths tested.

As an emitter of non – coherent narrow band red light. We use a safe, low cost device (BioBeam 660) that is widely used in our clinics to treat various wounds such as bed sores, diabetic ulcers, venous ulcers and post – operative wounds. The instrument used deserves special attention. Most of the low level laser instrument deliver an energy of 20 mw concentrated in an area of few square millmeters and result in a power density of 500 to 2000 mw/cm2 (13,14). The BioBeam 660, however, has a power density of only 15 mw/cm2 i.e, it does not exceed 1/3 the power density of sunlight at noon (approximately 60 mw/cm2). This difference in favor of the BioBeam 660 provides an added saftey dimension for the patient.

The aim of the study was twofold : to evaluate the effect of narrow band red light on inflammatory conditions such as Acne Vulgaris, and to establish criteria for the optimal use of red light on such conditions.

Five groups of patients were studied using specified mode and duration of LLRL treatment. Two more groups were examind combining LLRL treatment with medication. We noted less improvement with shorter exposure, and heightened results with increased use of the CW mode. However, when we compared 6 –minute durations of exposure to the CW mode, we noted no significant difference in results. But a marked decrease in compliance. Regarding the mode treatmen, combining PW and CW modes, as was done in Groups I, II and III did not change the course of the treatment which was influenced only by the amount of time spent employing the CW mode. We thus concluded that the optimal time of treatment was 6 minutes twice a day on up to three affected areas using the CW mode.

Two other groups using combined LLRL and medication were tested. One group was treated with Diana – 35, the other with minocyclin 50 rag twice a day. The group using Diana – 35 showed an initial worsening in the condition, a characterisic of this treatment. Usually there is a two month period before definite improvement is noticed , however, by combining Diana – 35 with BioBeam, we saw signs of improvement as early as one month after initiating treatment.

When we used BioBeam with minacycline, we saw a faster improvement but the quality of the improvement was the same.

We do not conclude that LLRL alone or together with minacycline is a safe and effective treatment to be considered among the treatments of Acne.

TABLE 1 – Acne Grading According to Burton Scale

Grade 0 - Total absence of lesions
Grade I -  Sub Clinical Acne – few comedons visible only in close examination
Grade II -  Comedonal Acne – comedons with slight inflammation.
Grade III - Mild Acne – inflamed papules with erythema.
Grade IV - Moderate Acne – many inflamed papules and pustules
Grade V - Severe Nodular Acne - inflamed papulesand pustules with several deep modular lesions.
Grade VI - Severe Cystic Acne – many modular cystic lesions with scarring.

TABLE II – Light Emitter Specification
Wavelengh - 660nm 660nm
Mode of operation - cw pw
Output power (mw) - 18 75(peak)
Illuminated area (cm’) - 2 2
Power density  (mw/cm2) - 8 34
Average power (mw) - 18 7.5
Pulses per second - 100
Duty ratio (%) - 10
Pulse time (ms) - 1
Delivery energy (j/min) - 1.08 0.45
Cw= continuous wave - pw= puise wave

TABLE III – Groups of Patients
Group no. IIIumination Mode Drugs Treatments
duration per day
I.8 1.5 min cw/pw none 2
II.8 2.5 min cw/pw none 2
III.8 4 min cw/pw none 2
IV.8 6 min cw none 2
V.5 8 min cw none 2
VI.8 6 min cw Diane-35 2
VII.8 6 min cw minocin 50mg 2
x2

TABLE IV – Rate of Drop – out of Patients from Study
Week  1st 2nd 3rd 4th 5th 6th total
Group I 1 2 3
Group II 1 2 1 4
Group III 1 1
Group IV 0
Group V 2 2
Group VI 1 1
Group VII 0


REFERENCES
1.Mester , E, et. Al. Effect of laser rays on wound healing. Am. J. Surg. 1971 ;122:532-535

2.Calderhead, Glen R. Review of the Biostimulation Session of the 11th Meeting of the American Society for laser medicine and Surgery (ASLMS). Lasers in Surgery and medicine Supplement 3, 1991.

3.Mester , E, et. Al. (1985). The biomedical effects of laser application. Lasers in Surgery and Medicine 5, 31-39.

4.Master, A.F and Master A.R (1988). Scientific backround of laser biostimulation, Laser 1(1) 23.

5.Karu, T.I (1988) Molecular mechanisms of the therapeutic effect of low – intensity laser irradiation. Lasers in life sciences, 2 (1) 53-74.

6.Sasanov, A.M et. Al. Low – intensity non coherent red light in the comprehensive treatment of gastroduodenal ulcers. Soy. Med. 12,42.

7.Abergal , R.P (1987). Biostimulation of wound healing by lasers ; experimental approaches in animal models and fibroblast cultures. Journal of Dermatology and Surgical Oncology 13, 127.

8.Burton J. et. Al The Prevalence of Acne Vulgaris in Adolescence. Dr J. Dream. 119 :85,1971.

9.Lusim, M et. Al Evaluation of the Degree of Effectiveness of BioBeam (Low level narrow band light) on the treatment of skin Ulcers and Delayed Post Operative Wound Healing. Accepted for publication in Orthopeadics, 1992.

10.Karu, T.I (1987). Photobiological Fundamentals of lowpower laser therapy. Journal of Quantum Electronics 10,23.

11.Young , S. et. Al Macrophage Responsiveness to light Therapy Lasers in Surgery and Medicine. 9 : 497-505 (1989).

12.Young , S. et. Effect of light on Calcium Uptake by Macrophages Original Articals. Lasers in Surgery and Medicine. Supplement 1991 by John Wiley & Sons Ltd.

13.King , P.R (1989) Low level laser therapy ; a review. Lasers in Medical Science 4, 141 –150.

14.Rochking, S. et. al Systemic Effect of low power laser irradiation on the peripheral and central nevous system, Cutaneous Wounds, and Burns. Lasers in Surgery and Medicine 9 ;174-182 (1989).