A Randomised Controlled Study for the Treatment of Acne Vulgaris using High Intensity 414nm Solid State Diode

Arrays
Caerwyn Ash

Declaration
The following potential conflict of interest relationships are germane to my presentation: Salary Travel expenses Clinical study funded by Equipment supplied by The Dezac Group, Cheltenham, UK

Study Objective

Objective: This study is designed to quantify the effectiveness of using a blue light device in a combination therapy with proprietary regimen creams in a self-treat investigation. A Randomised Controlled Study

Home Use Acne Treatment

Statistically 70% of people have had acne, both genders, all skin types. Sufferers may be too embarrassed to seek medical treatment.
This condition that so undermines self assurance and self esteem hits adolescence at such a vulnerable time in life.

Pathogenesis of Acne

Pathogenesis of Acne
BLUE Light

Wavelengths used in current treatment

414 nm LED White light Blue & Red light sources
585 nm Dye laser KTP laser 1450 nm diode laser Nd:YAG laser IPL

Why blue (414 nm)?

Investigative Study (2011)
In-Vitro Dose response

Mechanism of Propionibacterium acne Necrosis by initiation of Reactive Oxygen Species (ROS) by Porphyrin Absorption Ash C, Harris L, Maffeis T

Why blue (414 nm)?

Investigative Study (2011)
Scanning Electron Microscope of Propionibacterium

Mechanism of Propionibacterium acne Necrosis by initiation of Reactive Oxygen Species (ROS) by Porphyrin Absorption Ash C, Harris L, Maffeis T

Mode of Action

1.
Prepare skin
Exfoliate Chemical peel

2.
Illuminate Skin
Photochemical Absorption Bacteria Death

3.
Wound healing
Heat Capillaries Vasodilator creams

Pre-treatment Facial Wash

Weak Chemical peel Salicylic Acid Glycolic Acid Lactic Acid

Treatment 414 nm light source

220J over 6cm2 over 3 mins

Post-treatment Moisturiser
Salicylic Acid Glycolic Acid Lactic Acid Menthol Niacin

Study Design
Recruitment 45 subjects assessed for eligibility 4 subjects did not meet inclusion criteria 41 subjects accepted

Aimed for 50% Males, 50% Females 6 Males, 33 Females Ages ranged 16-37, average 22.1
15 subjects CONTROL

26 subjects TREATMENT Baseline at assessment Baseline + Device Week 1 Photography Week 2 Photography Week 4 Photography

Baseline at assessment Baseline Week 1 Photography Week 2 Photography Week 4 Photography

Cream's weighted at each session

Week 8 Photography
Week 12 Photography 26 subjects Completed 12 weeks 26 subjects Analysis & Questionnaire

Week 8 Photography
Week 12 Photography 15 subjects Completed 12 weeks 15 subjects Analysis & Questionnaire

Recruitment took place between December 2012 and January 2013 so that confounding effects of summer sunlight were avoided.

Inclusion Criteria
This ethics committee approved study recruited subjects aged between 16 and 45 years with mild-to-moderate facial inflammatory acne Male and Female Able to give informed consent and from whom written informed consent has been obtained. Following restrictions during the study: No change in facial wash product No medicated facial products No heavy foundation No makeup for each assessment at centre Male subjects to shave daily

Exclusion Criteria
Exclusion criteria were history of photosensitivity and pregnancy or lactation within the previous 3 months Subjects who had excessive facial exposure to sunlight or artificial UV-light within three months prior the study were excluded.

Psoriasis or Sandpaper acne

Participated in any clinical study during the previous month Migraines or seizures triggered by light Topical anti-spot medications, topical antibiotics or topical steroid usage

Washout periods for previous treatments were 8 weeks for oral antibiotics and topical treatments, 12 weeks for contraceptives containing cyproterone acetate, 52 weeks for oral Isotretinoin. Acne treatments were not allowed during the study.

Recruitment
Gloucester University Doctor surgery's Schools (Sixth form) Colleges

Social media

Device and Creams

Subjects given pre-treatment and post-treatment creams and device on one week after initial assessment. Watched a short video explaining how to use device and creams Close communication with subjects

Familiarity of applying creams

Acnes is very common and treatable, but finding suitable treatments can be expensive. Consumers are familiar with applying a regime of creams

Lesion Count - Photography

Standardised digital Images of four head positions provided full face analysis

Lesion Count - Custom Software

lesions from full face images counted using custom software.

Results Lesion Count

Results

Results

23 year old female, Only OTC medication

Results

26 year old female Tetracycline 4 years ago

Results

26 year old female, Tetracycline 2 years ago

Results

18 year old female

Results
All subjects in treatment group improved in lesion counts after 12 weeks Inflammatory lesion counts reduced by 50.02% in treatment group and increased 2.45% in controls. Reduction in lesion clearance was observed in the first 3 weeks after start of treatment. Treatment is pain and side effect-free.

Subject Feedback

Psychology
Psychological Aspects of Acne Vulgaris and the role of Social Media
Rebecca Whittall & Caerwyn Ash
Psychology, Health & Medicine: in press

Conclusion
Home-use blue light therapy improves inflammatory facial acne three weeks after first treatment with no serious adverse effects. An effective, drug free method of confronting this issue is presented by this study. The blue light device offers a valuable alternative to antibiotics and potentially irritating topical treatments. The onset of the effect was observable at week 3, and maximal between weeks 8 and 12. Although the device works well as a monotherapy, its best suited to a combination therapy

@caerwynash