Title:- A Single -Blinded Randomised Controlled Study to Determine the Efficacy of Omnilux Revive Facial Treatment in Skin Rejuvenation

Dr J Bhat on behalf of Dr Sean Lanigan, Dr Colin Whitehurst and Jan Birch. Lasercare clinics, Birmingham, UK.

Intro duction

The use of light technology in dermatology has grown rapidly in the last decade. There have been many developments in the use of light for the treatment of a wide variety of skin conditions from non-melanoma skin cancers1, 2,3,4 to facial resurfacing for crows feet and photo damaged skin.5, 6,7 Historically the use of CO2 lasers has been the mainstay for facial resurfacing and skin rejuvenation since the mid 1990s. It is accepted that photoageing and the subsequent visible effects is in part due to the breakdown of collagen by metalloprotinases and oxidative damage induced by exposure to UV light.8 Subsequent treatment with CO2 lasers improves these visible signs through tissue remodelling after cutaneous injury. However the effectiveness of this technique is limited by prolonged healing times, discomfort during the procedure (requiring local anaesthesia) and the risk of complications such as pigmentary disorders.8 The popularity of laser resurfacing has therefore decreased, while the demand for new procedures that provide optimum results with minimal side effects has continued regardless. Light Emitting Diode (LED) technology has been at the forefront of new light source development in recent years. LED technology offers a new vehicle for the delivery of non-coherent light in arrays of varying shape, suitable for the treatment of large surface areas. Whelan H et al have repeatedly proven the effectiveness of LED technology in delivering an optimum light dose consistently demonstrating the efficacy of LED therapy in tissue regeneration.9, 10

“The notion that the clinical manifestation of photodamage can be repaired by the application of selective wavelengths of light energy is a logical extension of the principles of non-selective ablation.”8

The various cell and tissue types in the body have their own unique light absorption characteristics, absorbing light at specific wavelengths. Studies have demonstrated that selective wavelengths have stimulatory effects on cell types. Most importantly this has been demonstrated in the formation of precursors to collagen, procollagen and collagen type I and the enzymes associated with cellular structure.11, 12, 13, 14 This study combines the knowledge of LED technology with the proven concepts of biostimulation to offer an effective, safe alternative to non-ablative skin rejuvenation. The objectives of the study were to establish if light therapy using Light Emitting Diodes at a wavelength of 633nm would stimulate facial skin rejuvenation.

Materials and Methods

Light Source

Omnilux Revive (PhotoTherapeutics Ltd, Manchester, United Kingdom) is a Light Emitting Diode (LED) based light source, delivering non-coherent red light at a wavelength of 630nm+/- 3nm and an intensity of 80mW/cm2 and a dose of 96J/cm2.

Clinical Protocol

For each healthy volunteer, age, sex, phototype and wrinkle grading were recorded. Phototype was evaluated using the Fitzpatrick classification (I-VI). 15, 16 Wrinkle grading was evaluated using an adapted version of the Glogau scale . Quote Volunteers had not received any previous aesthetic treatments to the treatment area within the last six months, this included laser treatment and or ablative or non-ablative cosmetic procedures. Baseline readings of skin elasticity and skin hydration were performed using a cutometer and corneometer (CM825®). 18, 19

Treatment

Healthy volunteers were randomised to receive the light dose to either the right or left side of the face. Control sides were occluded to prevent light incidence on the skin. Subjects’ faces were precleaned with Hidraderm cleansing lotion (SeSDerma, Valencia, Spain) and exposed to the light for 20 minutes.

Photography

Digital photographs using a Sony DSC-F707 were taken at baseline and at weeks three, eight and twelve. Conditions for photography remained constant throughout the trial.

Elasticity and skin hydration.

Volunteers’ skin measurements for elasticity were made using a cutometer and measurements for skin hydration were made using a corneometer (CM825®). 18, 19 Skin measurements were performed at baseline and at weeks three, eight and twelve. Cutometer readings were taken from subjects right and left temple and cheek area. Six corneometer readings were each taken from the right and left cheek areas and analysed to determine changes in skin hydration.

Procedure and Follow-up

Volunteers were treated 3 x weekly for 3 weeks, (9 treatments). During the study, volunteers were asked to qualitatively assess their response to treatment. Volunteers were assessed using digital photography, clinical grading and

elasticity and skin hydration measurements. All skin measurements were carried out at baseline and at weeks three, eight and twelve. Volunteer randomisation was blinded to the investigator. Post-treatment photography was evaluated for treatment response at the end of the study by the clinical investigator.

Results Patient satisfaction

The enrolment consisted of 23 healthy volunteers, age range 31 to 56 (mean 44), with visible signs of ageing,.

100

22 volunteers completed the treatment course.

90

40

8 weeks after the end of the study, 91% of volunteers reported visible changes to their

30 20

non 80 70 60 50

Patient Satisfaction

10

effect on the 0

64% reported a reduction in fine lines and wrinkles and a perception of softer skin. 68% reported smoother skin and over 50% reported that their skin felt

The therapy was well tolerated and there were no reported side effects. No pain was encountered during the treatment regime and there were no reported side effects such

Reduction in Fine Lines and WrinklesSkin feels softerSkin feel firmer

firmer,(FigureI).

Overall change in appearance of skinSkin feels smoother

as erythema and swelling.

Figure I Patient satisfaction, from post treatment assessment

Elasticity and skin hydration.

Optimum hydration effects were seen at 5 weeks post treatment. Mean elasticity measurements showed a decrease in the treated side of the face during the treatment regime. However this value rose at 5 weeks post treatment. Although as with mean elasticity a trend can be identified throughout and post treatment the p values for elasticity and skin hydration do not show statistical significance.

Clinical Photography

Baseline vs 5 week post-treatment

Left side treated. Note Changes in skin tone, texture, and fine lines

Baseline vs 5 week post-treatment

Left side treated. Note Changes in skin pigmentation

Conclusion

Omnilux, light only treatments are seen to be a safe alternative, non ablative skin rejuvenation treatment, that is well tolerated by all subjects. The subjective response seen in this study by all participants is extremely favourable, indicating that subject satisfaction was high. The blinded photographic assessment reported a clinical response in 59%, (p=0.046) of subjects.

Discussion

There are a number of limitations to this study that have impacted on the final statistical analysis of the results. The sample size of 22 was insufficient to detect the small changes in elasticity and hydration due to the level of within patient variability. The environmental and internal subject variability prevented a true detection of changes in skin parameters in such a small sample size. Work carried out since this study in Taiwan, using an identical protocol has demonstrated significant changes in skin elasticity. Interestingly the Taiwanese study also showed that there was no hyperpigmentation in skin types 4-5, that confers a significant advantage over IPL’s The study has demonstrated the need for further research to quantitatively evaluate skin changes. Combination facial treatments with other cosmeceuticals or drugs also need further investigation.

References

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