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Clinical Studies

Clinical testing plays a key role in validating the safety and efficacy of our products. It is also vital to substantiate product claims made throughout our communication, our website and on our packaging to ensure you feel reassured that the product we are offering you is not only safe but does what it says as it has been thoroughly tested.

 

Clinical study #1:  Lustre Pure Light Classic Home Use Device Study- European LED Academy


Authors/investigators:
Dr. Michèle Pelletier (MD) Dermatologist. Toulon. President of the European LED Academy. Lead investigator.
Dr. Linda Fouque (MD) Dermatologist. Nice. Vice President of the European LED Academy.
Dr. Yannick Saussaye (MD) Dermatologist. Montpellier. Vice President of the European LED Academy
 
About the study:
The clinical effectiveness of Lustre Pure Light Classic in mild to moderate acne vulgaris following the standard IFU (instructions for use) was assessed by 3 independent Dermatologists from the European LED Academy following a standardised assessment protocol and Acne scoring system.
All patients were washed out of all other treatments 4 weeks before the study commenced and only used the Lustre Pure Light Classic devices during the period of the study.
After the initial scoring and consenting process the clinical results were assessed by each investigator on days 30, 60, 90 with a further observational assessment carried out on day 120 to assess maintenance and persistence of results based on the standard IFU (instructions for use) protocol for maintenance treatment.

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Clinical study #2:  Clinical efficacy of home-use blue-light therapy for mild to moderate acne.


Authors/investigators:
MICHAEL H. GOLD* ** , WHITNEY SENSING** & JULIE A. BIRON**


 * Gold Skin Care Center, Department of Dermatology, School of Nursing, Vanderbilt University School of Medicine,
Vanderbilt University, Nashville, TN, USA, Fudan University (Shanghai Medical University), Shanghai, China, and
China Medical University, Shenyang, China,

**Tennessee Clinical Research Center, Nashville, TN, USA
 
About the study:
Introduction: Blue-light light-emitting diode (LED) therapy has become widely used for the treatment of inflammatory acne.

In this study we evaluated the efficacy of a home use blue-light LED application in improving lesions and shortening their time to clearance. Methods: This was an IRB approved randomized self-control study. For each patient ( n 30), 2 similar lesions, one of each side of the face were chosen for treatment with either a blue-light LED hand-held or sham device.
Treatments ( n 4) were conducted twice daily in the clinic and lesions were followed-up till resolution. Reduction in blemishes size and erythema and the overall improvement were evaluated by both the physician and the patients. Time to lesion resolution was recorded. Results: There was a significant difference in the response of lesions to the blue-light LED application as opposed to the placebo in terms of reduction in lesion size and lesion erythema as well as the improvement in the overall skin condition ( p 0.025). Signs of improvement were observed as early as post 2 treatments. Time to resolution was significantly shorter for the blue-light LED therapy.

Conclusion: The results support the effectiveness of using blue-light LED therapy on a daily basis for better improvement and faster resolution of inflammatory acne lesions.

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Clinical study #3:  An open study to determine the efficacy of blue light in the treatment of mild to moderate acne


Authors/investigators:

C. A. MORTON*, R. D. SCHOLEFIELD**, C. WHITEHURST*** & J. BIRCH***

*Department of Dermatology, Falkirk Royal Infirmary, Falkirk,

**Sequani Consumer, Vine House, New Street, Ledbury,
Herefordshire 

***Photo Therapeutics Ltd, Station House, Stamford New Road, Altrincham, UK

 

About the study:

 Background: The effective management of acne remains a challenge; achieving an optimal response whilst minimizing adverse events is often difficult. The rise in antibiotic resistance threatens to reduce the future usefulness of the current mainstay of therapy. The need for alternative therapies remains important.

Phototherapy has previously been shown to be effective in acne, with renewed interest as both endogenous and exogenous photodynamic therapies are demonstrated for this condition.

Objectives: To determine the effect of narrowband blue light in the reduction of inflammatory and noninflammatory lesions in patients with mild to moderate acne and to evaluate patient tolerance of the therapy.

Methods: We performed an open study utilizing a blue LED light source in 30 subjects with mild to moderate facial acne. Two weeks after screening, lesions were counted and recorded by lesion type. Over 4 weeks, patients received eight 10- or 20-minute light treatments, peak wavelength 409–419 nm at 40 mW/cm2. Assessments were taken at weeks 5, 8 and 12 and lesion counts were recorded. Repeated measures-ANOVA and Dunnett’s tests, respectively, allowed assessment of the different scores over time and permitted comparison of mean counts.

Results: An overall effect on inflammatory counts was observed at week 5, and a statistically significant decrease in inflamed counts was detected at the week 8 assessments, which continued to week 12. There was little effect on non-inflamed lesions. The treatment was well tolerated with adverse events experienced generally rated as being mild and usually self-limiting.

Conclusions: Eight 10- or 20-minute treatments over 4 weeks with a narrowband blue light was found to be effective in reducing the number of inflamed lesions in subjects with mild to moderate acne. The treatment had little effect on the number of comedones. The onset of the effect was observable at the first assessment, at week 5, and maximal between weeks 8 and 12. Blue light phototherapy using a narrowband LED light source appears to be a safe and effective additional therapy for mild to moderate acne.

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 Clinical study #4:  Efficacy of ALA-PDT vs blue light in the treatment of acne


Authors/investigators:

R. Akaraphanth, W. Kanjanawanitchkul, P. Gritiyarangsan
Institute of Dermatology, Bangkok, Thailand

 

About the study:

Background: Photodynamic therapy (PDT) is based on the principle of using light excitation of a wavelength-specific endogenous or exogenous photosensitizer to destroy the target tissue, and has shown efficacy in the treatment of certain non-melanoma skin cancers. PDT using aminolevulinic acid (5-ALA) has attracted attention in the treatment of acne vulgaris.

Method: Twenty patients with moderate to severe acne vulgaris on the face were treated with four sessions of topical ALA-PDT with blue light (415 nm) on the right side of the face compared with blue light alone on the left side of the face, each treatment being 1 week apart.
Ten percent of topical ALA was applied to acne spots on the right side of the face with a 1-h incubation period and the entire face was treated with 48 J/cm2 of 415 5 nm light from an articulated LED planar array.
Evaluation was performed by counting acne lesions at baseline, 4, 8, 12 and 16 weeks after the beginning of the treatment. Biophysical measurements included sebum levels and the erythema, and melanin indices.

Result: At the given assessment times 4, 8, 12 and 16 weeks after the beginning of the treatment, the mean percent reduction in inflamed lesions counts tended to be higher in the ALA-PDT areas; it was 32%, 50.9%, 65.9% and 71.1%, respectively, compared with the blue-light-alone treatment, which was 20.7%, 27%, 57.7% and 56.7%, respectively, but without any statistical significance (P50.092). There was no demonstrable significant change in sebum excretion, erythema or the melanin index after treatment. The side effects were pain, stinging, peeling, erythema, pruritus, oozing and pustules. These side effects were stronger on the ALA-PDT-treated side.

Conclusion: From this study, the trend for ALA-PDT with blue light to be superior to blue light alone was observed, but it did not reach statistical significance. ALA-PDT had more side effects.

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Clinical study #5: Safety and Effectiveness of a New Blue Light Device for the Self-treatment of Mild-to-moderate Acne


Authors/investigators:
*RONALD G. WHEELAND, MD, FACP; **ANDREA KORECK, MD, PhD
*Department of Dermatology, University of Missouri, Columbia, Missouri; **Department of Dermatology and Allergology, University of Szeged, Hungary
 
About the study:
Objective: To assess the safety and effectiveness of treating acne for eight weeks using a new blue light device at a dose of ~2J/cm2/day (representing typical full-face treatment) or ~29J/cm2/day (representing the typical dose after localized spot treatment of acne).

Design: Prospective, single-center, open-label study evaluating two levels of blue light in each subject.

Setting: Subjects were recruited from the local community for self-treatment at home.

Participants: Thirty-two subjects with mild or moderate facial acne vulgaris. Measurements: Inflammatory lesion count; number, severity, and redness of flares; improvement in skin characteristics (overall appearance, clarity, radiance, tone, texture, and smoothness); tolerability; subject satisfaction.

Results: The blue light treatment was associated with significant
reductions from baseline in inflammatory lesion count as early as Week 1 with ~29J/cm2/day and Week 3 with ~2J/cm2/day (P≤0.01). It was also associated with significant reductions in the number, severity, and redness of flares and with improvements in the skin’s appearance, clarity, radiance, tone, texture, and smoothness. Overall, 53 percent of subjects considered the treatment much gentler than traditional acne treatments and 61 percent were satisfied. Three adverse events were probably related to treatment—minimal transient skin dryness (2) and minimal transient hyperpigmentation (1).

Conclusion: The blue light treatment is effective and well tolerated, offering rapid, gentle, and convenient treatment of inflammatory acne. The blue light device offers a valuable alternative to antibiotics and potentially irritating topical
treatments and can also be used adjunctively to complement other therapies.
(J Clin Aesthet Dermatol. 2012;5(5):25–31.)

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