cochrane database of systematic reviews (protocols) || light therapies for acne
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Light therapies for acne (Protocol)
Car J, Car M, Hamilton F, Layton A, Lyons C, Majeed A
This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The CochraneLibrary 2009, Issue 3
http://www.thecochranelibrary.com
Light therapies for acne (Protocol)
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T A B L E O F C O N T E N T S
1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
iLight therapies for acne (Protocol)
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[Intervention Protocol]
Light therapies for acne
Josip Car1, Mate Car1, Fiona Hamilton1, Alison Layton2 , Colin Lyons3, Azeem Majeed1
1Department of Primary Care and Social Medicine, Faculty of Medicine, Imperial College London, London, UK. 2Harrogate Health
Care NHS Trust, Harrogate District Hospital, Harrogate, UK. 3Department of Primary Care & Social Medicine, Faculty of Medicine,
Imperial College London, London, UK
Contact address: Josip Car, Department of Primary Care and Social Medicine, Faculty of Medicine, Imperial College London, Reynolds
Building, St Dunstan’s Road, London, W6 8RP, UK. [email protected].
Editorial group: Cochrane Skin Group.
Publication status and date: New, published in Issue 3, 2009.
Citation: Car J, Car M, Hamilton F, Layton A, Lyons C, Majeed A. Light therapies for acne. Cochrane Database of Systematic Reviews2009, Issue 3. Art. No.: CD007917. DOI: 10.1002/14651858.CD007917.
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
A B S T R A C T
This is the protocol for a review and there is no abstract. The objectives are as follows:
To explore the effects of light treatment of different wavelengths for acne.
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B A C K G R O U N D
Description of the condition
Acne is a common skin condition which tends to affect the face,
chest, and back. It can range from a mild form with comedones
(blackheads and whiteheads) and a few small spots (pustules and
papules) to more severe forms with many lesions, including nod-
ules and deep cysts. Mild acne is more prevalent than the severe
form (Stathakis 1997; Kilkenny 1998) and most teenagers will
grow out of it. However, it can persist into adulthood, or start in
adulthood, when it is often more difficult to manage and tends to
affect women more often than men (Goulden 1999; Poli 2001;
Goulden 2003).
Impact
Acne affects 70% to 90% of teenagers (Leyden 1997; Webster
2002), and can lead to scarring of the skin, which is difficult
to treat effectively (Layton 1994; Jordan 2000). Sufferers often
develop low self-esteem, and low mood (Baldwin 2002; Tan 2004;
Thomas 2004), which can even lead to problems with employment
(Cunliffe 1986). The impact of acne has been assessed to be as
severe as epilepsy or asthma on the quality of life (Thomas 2004).
Causes
Acne is usually precipitated in puberty by a rise in hormones, par-
ticularly androgens (Thiboutot 2004, Zouboulis 2004). This leads
to enlargement and hyperkeratinisation of the sebaceous glands of
the pilo-sebaceous unit. Sebum builds up, plugging the hair fol-
licle and leading to the formation of comedones (whiteheads and
blackheads, Cunliffe 2004). Finally, skin bacteria, notably Propi-onibacterium acnes (P. acnes), become trapped inside the duct and
induce an intense inflammatory response, resulting in pustules,
papules and, in the worse cases, nodules and cysts. Insulin resis-
tance has been implicated in the development of acne, as acne is a
common complaint of women with polycystic ovarian syndrome
(Archer 2004; Pfeifer 2005).
Conventional treatments
First line treatments for acne include topical agents, such as
retinoids and benzoyl peroxide, to target sebum production and
plugging of the hair follicle (Garner 2003). Topical and oral an-
tibiotics may also be prescribed to control the acne bacteria, al-
though antibiotic resistance is becoming a problem (Seaton 2003).
Women may be prescribed oral contraception containing cypro-
terone-acetate (Dianette), which is antiandrogenic (Arowojolu
2004). Oral isotretinoin is very effective for moderate to severe
acne. It is a synthetic form of vitamin A. It is often curative but
has side-effects (Greenwood 1986) which some with the condition
find unacceptable. Common side-effects include dry skin, eyes,
lips, and mucous membranes (Charakida 2004). It is also terato-
genic, limiting its use in women of childbearing age (Stern 1989).
The incidence of side-effects of treatment with Isotretinoin and
its efficacy, is the subject of an ongoing Cochrane review (Gupta
2004).
Description of the intervention
Light therapies for acne utilise light with different properties
(wavelength, intensity, coherent/incoherent light) to achieve a ben-
eficial result for those with acne (Mariwalla 2005). Lasers are the
commonest light sources for acne therapy. ’Laser’ stands for ’light
amplification by stimulated emission of radiation’. They produce
a high-energy beam of light of a precise wavelength range, which
can be focused accurately. Several different delivery systems are
used in clinical practice, incorporating timing controls for safety
and cooling systems to reduce discomfort during treatment.
How the intervention might work
Light therapies for acne are believed to work mostly by killing
P. acnes and by damaging and shrinking sebaceous glands thus
reducing sebum output. Studies report few side-effects (Elman
2003) and these are temporary (Friedman 2004). Light therapies
may be given once or twice weekly as a course of 6 to 10 treatments,
and each irradiation lasts 10 to 20 minutes (Mariwalla 2005).
Treatment is not usually available in the NHS and may be accessed
privately via dermatologists or clinics, but can be expensive.
P. acnes produce endogenous porphyrins, which absorb light to
form highly reactive singlet oxygen, which destroys the bacteria
(Mariwalla 2005). Porphyrins have peak absorption at blue light
wavelengths, so blue light is often used to treat acne. Red light is
also absorbed by porphyrins, and can penetrate deeper into the skin
(Ross 2005) where it may directly affect inflammatory mediators.
Other light therapies attempt to selectively target and damage se-
baceous glands directly, reducing their size and thus sebum output
(Lloyd 2002). These include infra-red lasers, low energy pulsed-
dye lasers, and radiofrequency devices (Mariwalla 2005).
Photodynamic therapy (PDT) uses specific light-activating
creams. These are absorbed into the skin and amplify the response
to light therapy but tend to produce more severe side-effects. There
are also concerns that PDT may interfere with the skin’s natural
immune mechanisms (Böhm 1998) and so cause long-term skin
damage.
Some authors have observed an increase in transforming growth
factor (TGF)-Beta1 mRNA 24 hours after treatment with lasers.
TGF-Beta1 is an immunosuppressive cytokine that also stimulates
the formation of collagen. It is thought that its increase following
laser treatment promotes the resolution of inflammation (Seaton
2006).
Why it is important to do this review
Acne is chronic, often flares up for no obvious reason, and increas-
ingly persists well into adulthood. Most oral and topical treatments
are less effective than oral isotretinoin, and combination treatment
regimens can be problematic, time consuming, and difficult to
follow. Antibiotics are often used, but there are concerns that this
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may give rise to bacterial resistance (Crawford 1979; Leyden 1983;
Eady 1998). Thus all conventional treatments have limitations.
Recently some authors have proposed diverse light therapies as a
new treatment, although the outcomes of existing trials are con-
tradictory. Light therapies also seem to be increasingly popular
among consumers and many light sources are now offered for peo-
ple to purchase directly using the Internet. Therefore there is a
lot of public interest in this treatment, as well as interest from
health service commissioners. Establishing what evidence there is
to support treatment of acne with light of different wavelengths is
therefore critical (Mariwalla 2005).
O B J E C T I V E S
To explore the effects of light treatment of different wavelengths
for acne.
M E T H O D S
Criteria for considering studies for this review
Types of studies
Randomised controlled trials (RCTs), which may be of two types:
those which compare two groups of subjects where one group is
randomised to receive treatment and the other serves as the control
group; and those which apply treatment randomly to one part of a
subject’s body compared with another part which serves as control
(such as split-face studies). We will not include cross-over trials
because an intervention for acne may have a lasting effect that can
carry over to subsequent periods of the trial.
Types of participants
Anyone with a diagnosis of mild, moderate, or severe acne vulgaris
defined by any classification system.
Types of interventions
We will search for any therapy based on the healing properties of
light for treatment of acne vulgaris. Therapies that combine light
with other treatment to boost the effect of light will also be ac-
cepted. We will focus on a comparison between the effectiveness
of treatment with light of different properties - coherence, wave-
length, and intensity.
A study will be included if the description of the intervention
that was applied was adequately described (described in sufficient
detail to understand the key steps undertaken) and used a validated
measure of improvement in acne vulgaris as one of its outcomes.
When necessary, we will request additional information describing
the intervention from study authors to help determine eligibility
(for example, details of the measurement methods used).
Types of outcome measures
Primary outcome measure
(i) Participant’s global assessment of improvementThis is likely to be recorded using a Likert or Likert-like scale
(for instance, selecting from the following categories the extent
of change of their acne after treatment: acne has worsened a lot;
worsened a little; stayed the same; improved a little; or improved
a lot).
(ii) Investigator-assessed change in lesion countThe change or percentage change from baseline in the number of:
• inflamed lesions (ILs) (papules or pustules or both)
• non-inflamed lesions (NILs) (blackheads or whiteheads or
both)
• nodules and cysts (for nodulocystic acne only)
If individual lesion counts are not available, then the change or
percentage change from baseline in the number of:
• ILs and NILs; or
• combined count of all lesion types.
Secondary outcome measures
(i) Investigator-assessed change in acne severityThe change in acne severity from baseline, using: a published grad-
ing scale (like the Leeds grading system, which involves counting
lesions and weighting them according to severity to give a com-
bined grade); or a severity index determined by the lesion count.
(ii) Investigator’s global assessment of improvementThis is likely to be recorded using a Likert or Likert-like scale. The
investigator’s assessment will be disregarded if it was performed
without using baseline photographs.
(iii) Changes in Quality of lifeAssessed using a recognised tool.
(iv) Investigator-assessed severe adverse effectsIf blistering or scarring of the skin follows treatment with light
therapy then we expect the severity of the adverse effect to be
reported, and whether it resolves in the short-term or is permanent.
Other adverse outcomes
We will record the incidence and severity of all other adverse events
reported in the included studies. We will use the system organ
classes (SOCs) defined in the latest version of medDRA (MedDRA
2007) .
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Timing of outcome assessment
We will consider short-term (2 to 4 weeks), medium (5 to 8 weeks),
and long-term (longer than 8 weeks) follow-up periods. The long-
term data are the primary endpoint but we are also interested in
short-term data, indicating early improvement, which may en-
courage participants to continue with treatment .
Exclusion criteria
• Studies which were not RCTs;
• Studies not focused on the healing properties of light in the
management of acne;
• Studies on light therapies for acne scars.
Search methods for identification of studies
Electronic searches
With the help of the Cochrane Skin Group, we will search for
relevant published trials in:
The Cochrane Skin Group Specialised Register;
The Cochrane Central Register of Controlled Trials (CENTRAL)
in the latest issue of The Cochrane Library;MEDLINE (from 2005);
EMBASE (from 2007);
PsycInfo (from inception);
CINAHL (Cumulative Index to Nursing & Allied Health Litera-
ture) (from 1980);
LILACS (Latin American and Caribbean Health Science Infor-
mation database, from inception);
ISI Science Citation Index (on BIDS) ISI web of science;
Dissertation Abstracts International (1861).
The UK Cochrane Centre has an ongoing project to systemati-
cally search MEDLINE and EMBASE for reports of trials which
are then included in the Cochrane Central Register of Controlled
Trials. Searching has currently been completed in MEDLINE to
2004 and in EMBASE to 2006. Further searching will be under-
taken for this review by the Cochrane Skin Group to cover the
years that have not been searched by the UKCC.
The draft search strategy for MEDLINE (OVID) is shown in
Appendix 1. This will be adapted to include additional search
terms where necessary. A similar strategy will be used for EMBASE
and the other databases listed.
Ongoing Trials
We shall search for ongoing trials in the following trials registers:
The metaRegister of Controlled trials www.controlled-trials.com
The U.S. National Institutes of Health Ongoing Trials Register
www.clinicaltrials.gov
The Australian and New Zealand Clinical Trials Registry
www.anzctr.org.au
The World Health Organisation International Clinical Trials Reg-
istry Platform www.who.int/trialsearch
The Ongoing Skin Trials register www.nottingham.ac.uk/
ongoingskintrials
Searching other resources
Grey Literature
We shall attempt to find unpublished studies through searching
grey literature sources such as Internet search engines Google,
Google Scholar, and Copernicus.
Reference lists
We will look through the reference lists of published studies and
reviews for references to RCTs.
Correspondence
We will consult trial authors of included and excluded trials pub-
lished in the last 15 years and other experts in the field of optical
therapies for acne in order to identify unpublished RCTs.
Adverse Effects
We will not perform a separate search on adverse outcomes, but
will record adverse outcomes reported in the included trials and
discuss the implications of those adverse outcomes.
Language
We will not restrict the search to trials published in English only
and will arrange translation as necessary.
Data collection and analysis
Selection of studies
Two authors (MC and CL) will scan the titles and abstracts of
studies identified by the searches. If studies do not address the
study of a light therapy for acne we will exclude it. If any of the
authors feels that a paper could be relevant, it will be retrieved in
full text and each author will independently check that it meets
the pre-defined selection criteria, with any differences of opinion
being resolved by discussion with the review team. Those studies
that are excluded after reading the full paper will be listed in the
’Characteristics of excluded studies’ table.
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Data extraction and management
Two authors (MC and FH) will independently record data using
a specially designed data extraction form. A third team member
(JC) will resolve any differences of opinion. One author (FH)
will then enter the data into RevMan. We will define treatment
success as anything above the first category of improvement on a
Likert scale, or more than 50% improvement from baseline on a
continuous scale.
All other outcomes will be recorded as the actual or percentage
change from baseline.
Assessment of risk of bias in included studies
We will assess the methodological quality of each included study
using the following criteria and record this information in the
’Risk of bias’ section within the ’Characteristics of included studies’
table:
a) how the randomisation sequence was generated;
b) whether allocation was adequately concealed;
c) whether participants, clinicians, or outcome assessors were
blinded as appropriate, who was blinded and not blinded (partic-
ipants, clinicians, outcome assessors) if this is appropriate;
d) how many participants were lost to follow-up, and whether
reasons for losses were reported;
e) whether the intention-to-treat principle was followed, where
participants are analysed in the groups to which they were origi-
nally randomised .
In addition we shall report on:
f ) the baseline comparisons of the participants for age, sex, dura-
tion, location, and severity of acne;
g) light source identity, dose, duration of treatment, and adequacy
of instructions if self-administered;
h) whether outcome measures were described and their assessment
was standardised;
i) whether previous acne treatment was discontinued in a timely
manner prior to the trial;
j) whether concomitant acne treatment was permitted, and if so
whether standardised;
k) the use and appropriateness of statistical analyses, where data
are not reported appropriately in the original publication.
Measures of treatment effect
We will express the results as risk ratio (RR) and 95% confidence
intervals (CI) for dichotomous outcomes. Mean differences will
be used for continuous outcomes with 95% CI, with standardised
mean differences being used where different but comparable mea-
sures have been used across trials, e.g. for quality of life. We shall
express the result as ’number needed to treat’ for dichotomous
outcomes where appropriate.
Unit of analysis issues
Where there are multiple intervention groups within a trial, we
will make pair wise comparisons of light therapies with different
wavelengths versus no treatment, placebo, and conventional treat-
ment. We will analyse internally controlled trials using appropriate
techniques for paired designs and these studies will not be pooled
with studies of other designs.
Dealing with missing data
If participant drop-out leads to missing data we shall conduct an
intention-to-treat analysis. We will contact trial authors or spon-
sors of studies which are less than 15 years old to provide missing
statistics such as standard deviations. For dichotomous outcomes,
we will regard participants with missing outcome data as treat-
ment failures and include these in the analysis. For continuous
outcomes, we will carry forward the last recorded value for partic-
ipants with missing outcome data.
Assessment of heterogeneity
We will assess statistical heterogeneity using the I2 statistic. If the I2 statistic is greater than 80% we shall synthesise data using meta-
analysis techniques.
Assessment of reporting biases
We will test publication bias by the use of a funnel plot when
adequate data are available for similar light therapies.
Data synthesis
For studies with a similar type of design, we will perform a meta-
analysis to calculate a weighted treatment effect across trials, using
a random-effects model. Where it is not possible to perform a
meta-analysis we will summarise the data for each trial.
Subgroup analysis and investigation of heterogeneity
If substantial heterogeneity (I2 > 50%) exists between studies for
the primary outcome, we will look for the reasons for this, such as:
differences in disease severity, exposure, and duration of treatment.
We will undertake further subgroup analysis if sufficient informa-
tion is given. The groups will include those with different severity
or onset of acne and the age of participants (child or adult).
Sensitivity analysis
We intend to undertake sensitivity analyses to determine the effects
of excluding the poorer quality trials, those with a moderate or high
risk of bias as defined in the Cochrane Handbook of Systematic
Reviews of Interventions (Higgins 2008).
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Adverse outcomes
We will describe:
(a) whether the methods used to record adverse events were ap-
propriate;
(b) whether reporting of adverse outcomes was adequate.
Other
Where necessary, we will contact the trial authors for clarification.
We will use GRADEPro to create the Summary of Findings (SoF)
table.
A C K N O W L E D G E M E N T S
This protocol is based on the Cochrane protocol by Leonard T,
Eady A, Jordan J, Leonardi-Bee J. Complementary therapies for
acne vulgaris, 2006 (Leonard 2006)
The Cochrane Skin Group editorial base would like to thank Amy
Taub who was the External Content Referee, Jack Tweed the Con-
sumer Referee, Sue Jessop the Key Editor, Jo Leonardi-Bee the Sta-
tistical Editor, and Philippa Middleton the Methodology Editor
on this protocol.
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3–5.
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7Light therapies for acne (Protocol)
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A P P E N D I C E S
Appendix 1. MEDLINE draft search strategy
1. randomized controlled trial.pt.
2. controlled clinical trial.pt.
3. randomized.ab.
4. placebo.ab.
5. clinical trials as topic.sh.
6. randomly.ab.
7. trial.ti.
8. 1 or 2 or 3 or 4 or 5 or 6 or 7
9. humans.sh.
10. 8 and 9
11. acne vulgaris.mp. or exp Acne Vulgaris/
12. lasers.mp. or exp Lasers/
13. seasons.mp. or exp Seasons/
14. sunlight.mp. or exp Sunlight/
15. ultraviolet therapy.mp. or exp Ultraviolet Therapy/
16. photolysis.mp. or exp Photolysis/
17. phototherapy.mp. or exp Phototherapy/
18. photochemotherapy.mp. or exp Photochemotherapy/
19. photosensitizing agents.mp. or exp Photosensitizing Agents/
20. 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19
21. 11 and 10 and 20
H I S T O R Y
Protocol first published: Issue 3, 2009
C O N T R I B U T I O N S O F A U T H O R S
Link with the editorial base (FH)
Draft the protocol (MC, FH, and AL)
Perform literature searches (JC and MC)
Identify relevant titles and abstracts from searches (MC and CL)
Select studies for inclusion (JC and MC)
Extract the data from the studies (MC and FH)
Resolve differences of opinion (JC)
Enter the data into RevMan and perform the meta-analysis (FH)
Draft the final review (FH)
Review and amend the text of the report as necessary (JC, AM, and AL)
8Light therapies for acne (Protocol)
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D E C L A R A T I O N S O F I N T E R E S T
None known.
S O U R C E S O F S U P P O R T
Internal sources
• Members of the Department of Primary Care and Social Medicine, Imperial College, London, UK.
Access to libraries and MEDLINE, IT and statistical support, advice, and time to write this protocol.
External sources
• Dr Alison Layton, Consultant Dermatologist, Harrogate and District NHS Foundation Trust, North Yorkshire, UK.
For help and advice while writing this protocol.
9Light therapies for acne (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.