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Trial registered on ANZCTR


Registration number
ACTRN12617000621314
Ethics application status
Approved
Date submitted
17/08/2015
Date registered
1/05/2017
Date last updated
1/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The North Queensland ‘Sun-Safe' Clothing Study: effectiveness of sun-protective clothing in preventing or delaying the development of pigmented moles in early childhood.
Scientific title
A cluster randomised controlled intervention trial of sun-protective clothing in 1-35 month-old Caucasian children attending daycare centres in Townsville, Queensland, Australia. The study is designed to determine whether a significant proportion of the melanocytic naevi (pigmented moles) which develop in early childhood can be prevented or delayed.
Secondary ID [1] 287288 0
Nil Known
Universal Trial Number (UTN)
U1111-1173-2918
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
melanocytic naevi 295924 0
melanoma 295925 0
over-exposure to sunlight 295930 0
Condition category
Condition code
Public Health 296183 296183 0 0
Epidemiology
Cancer 296184 296184 0 0
Malignant melanoma
Skin 296185 296185 0 0
Normal skin development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This prospective cluster-randomised controlled intervention trial involved children aged 1-35 months-old (at baseline) attending intervention daycare centres (n=13) wearing sun-protective study garments and legionnaire hats while at daycare.

All daycare centres in the intervention group were given sufficient numbers of the following study garments (in a range of sizes) to ensure that they could clothe all children in attendance at the centre in our study garments each day:

1) Ultraviolet Protection Factor (UPF) 50-plus legionnaire hats;

2) 100% cotton T-shirts offering "very good protection" (i.e. UPF 25-39 blocks between 96 percent and 97.4 percent of erythemally effective UVR) with sleeves 21 percent longer than T-shirts made to Australian standard sizing;

3) water-resistant nylon taslon shorts designed to cover the legs to below the knees and made of UPF 40 rated fabric (i.e. blocks at least 97.5 percent of erythemally effective UVR) providing "excellent protection".

4) water-resistant UPF 40 rated nylon taslon long-sleeve shirts for use during outdoor water-play.

Study clothing was used and maintained (laundry service provided) in these 13 intervention centres continuously for 5.5 years from 2000 until mid-2005, when the last child enrolled in the intervention group had their 3-year skin examination. The intervention generally involved children wearing study garments for a duration of at least 3 years of follow-up (from the time baseline naevus count was performed). Children leaving the daycare centre permanently before achieving 3 or more years of follow-up were given a final skin examination prior to departure, whenever possible, so that data for shorter periods of observation could also be included in the analysis (intention to treat).

Staff members at intervention centres were trained to dress all children in this clothing on arrival at the centre each day in order to ensure that each child's trunk, posterior neck, upper arms and thighs were fully covered at all times when outdoors (i.e. T-shirt sleeves to cover to at least the elbows and shorts to cover to below the knees). Staff were instructed not to change children back into their own clothes until just prior to them leaving the centre at the end of each day. Laminated signs were also put on the exit doors of intervention child-care buildings to remind staff to ensure all children were dressed in study clothing before going outdoors. Compliance in intervention centres was observed and recorded when collecting dirty garments for laundering twice per week and also by monitoring weekly laundry volumes at these centres.

Parents of “intervention children” were also educated about the correct fit and use of the study clothing used in the daycare setting. A UPF 50-plus legionnaire hat and high-UPF swimwear (long-sleeved UPF 40 nylon taslon shirt and commercially available UPF 50-plus Lycra (nylon elastane) suit with long sleeves with either full or knee-length legs) was given to each child attending an intervention centre to use when swimming at home or places other than daycare (issued at time of recruitment and annually thereafter for 3 years at the beginning of Summer). Home use of sun-protective garments (including the sun-protective swimwear given to intervention children) was unable to be monitored by direct observation. Consequently, this was achieved by including relevant questions in the self-administered sun exposure questionnaire completed annually by the parents of participating children for the duration of the intervention (3+ years).

The 12 daycare centres assigned to the control group did not receive sun-protective clothing. Likewise the children attending the control daycare centres received no sun-protective clothing for daycare or home use, and continued to receive the usual level of sun-protection provided by the daycare centre they attended for the duration of the study. To prevent contamination of the control population, the study garments were manufactured for the study only.

Similar to children in the intervention group, control children were examined for melanocytic naevi at baseline and annually thereafter for 3+ years, or until they were ready to start school or leave the centre for other reasons (relocating etc). Movement of children between intervention and control centres was monitored.
Intervention code [1] 292608 0
Prevention
Comparator / control treatment
Children attending one of the 12 daycare centres assigned to the control group continued with their usual sun-protection regime at daycare and while at home.
Control group
Active

Outcomes
Primary outcome [1] 295857 0
The primary outcome variable is the total number of incident (new) melanocytic naevi developing on the whole body (excluding the genitals, buttocks and scalp) between the baseline skin examination and the final skin examination.

More specifically, consent was sought from the parents of all Caucasian children aged 1-35 months-old attending the 25 participating daycare centres during the recruitment phase (Nov 1999-July 2002 inclusive). All consenting eligible children underwent a full-body skin examination to identify all of the melanocytic naevi on their body at baseline and annually thereafter for at least 3 years (last follow-up examination conducted July 2005).

Full body melanocytic naevus examinations were conducted in accordance with the IARC Protocol (English et al 1990) and performed by an epidemiologist trained by dermatologists in the recognition of pigmented lesions who had 10+ years experience in conducting skin examinations to count melanocytic naevi (S.L. Harrison). Furthermore, very high concordance of melanocytic nevus counts (concordance correlation coefficient 0.97 (95% CI: 0.95-0.98) was found when comparing blinded counts of the observer (SLH) for a sample of 49 of these children (March 2003, Harrison et al 2005) against those of an experienced visiting dermatologist (Prof J Bauer).
.
Timepoint [1] 295857 0
The total number of incident (new) melanocytic naevi present was assessed yearly for at least 3 years after baseline.
Secondary outcome [1] 316728 0
The secondary outcome is the number of incident (new) melanocytic naevi present on those body-sites specifically protected by the study clothing (i.e. upper arms, thighs, posterior neck).

Full body melanocytic naevus examinations were conducted in accordance with the IARC Protocol (English et al 1990) and performed by an epidemiologist trained by dermatologists in the recognition of pigmented lesions who had 10+ years experience in conducting skin examinations to count melanocytic naevi (S.L. Harrison). Furthermore, very high concordance of melanocytic nevus counts (concordance correlation coefficient 0.97 (95% CI: 0.95-0.98) was found when comparing blinded counts of the observer (SLH) for a sample of 49 of these children (March 2003, Harrison et al 2005) against those of an experienced visiting dermatologist (Prof J Bauer).
.
Timepoint [1] 316728 0
The number of incident (new) melanocytic naevi present on sun-protected body-sites was assessed annually for at least 3 years after baseline.

Eligibility
Key inclusion criteria
Children aged 1–35 months-old of Caucasian decent (i.e. with at least two grandparents of European origin) who regularly attended one of the 25 participating daycare centers in the recruitment period of November 1999 to July 2002 inclusive, and whose parents plan to reside in Townsville for the forseeable future and are willing to provide written informed consent for their child to participate in the study.
Minimum age
1 Months
Maximum age
35 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children 36 months or older;

Children with three of more non-Caucasian grandparents (of non-European origin);

Children who attend a participating daycare center at irregular intervals or on a casual basis;

Children whose parents expect to leave Townsville in less than 12-months;

Children for whom parental consent is not provided.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Cluster randomisation was performed - daycare centres were considered to be the unit of randomization.

Prior to commencing the study, the availability and quality of shade at all daycare centres in Townsville offering care to children under 2years-old was assessed. A 100% response was achieved. Consequently, shade availability and quality was assessed at 28 daycare centres in Townsville in conjunction with a UV Physicist (Dr Aurel Moise) by measuring the ratio of covered to uncovered play areas and the vertical and horizontal penetration of sunlight for at least five shade structures. Information on the amount of shade available was summarised by Dr Moise at the central administration site (3 levels) while the socio-economic status (SES) of the suburb (SEIFA Index 3 levels) in which the daycare centre was located was determined by the study Biostatistician (Dr Buettner).

Prior to random assignment of these 28 daycare centers into intervention and control groups, daycare centres were numbered 1-28 and were paired with the centre which most similar to it on the basis of shade availability (3 levels) and SEIFA value (3 levels). Once a list of paired numbered daycare centres was drawn up, allocation concealment was achieved using opaque envelopes containing either a 1 or a 2 and asking the study biostatistician who was "off-site" (i.e. not involved in field work nor in contact with the daycare centres) to select the envelopes that assigned one centre in each pair to the intervention group and the other to the control group. Of the 14 daycare centres allocated to the intervention group, it became evident during recruitment visits that one centre would be impractical for inclusion (and thus deemed ineligible) as it didn't have a separate unit for infants. The same was found to be true for one control daycare centre. All 13 eligible intervention centres agreed to participate and were then notified of their allocation to the clothing intervention group while only 12 of the eligible 13 control centres agreed to participate further.

Because this was a cluster-randomised trial, all eligible children were assigned to the intervention or control group based on the assignment of the daycare centre they attended.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A list was generated containing the names of each of the 28 matched-pairs of daycare centres (matched on 3 levels of shade availability and 3 SEIFA levels as described above). The name of one daycare centre in each pair written in the left-hand column and the other daycare centre name was written in the right-hand column (as shown below).

Pair 1 Centre A Centre B
Pair 2 Centre C Centre D
Pair 3 Centre E Centre F
...etc

A simple randomization process was used to determine which of the daycare centre in each 28 pair would be assigned to the intervention group and which centre would be assigned to the control group. Simple random assignment was achieved by placing a card containing the number 1=intervention group in one opaque envelope and a card containing the number 2=control group in a second opaque envelope.

The chief investigated concealed one envelope in each hand behind her back and asked the study Biostatistician to choose an envelope. The number on the card contained in the chosen envelope (1=intervention or 2=control) was assigned to the centre whose name was written in the left hand column (i.e. Centre A) and the opposite assignment was used for centre B. The cards were returned to the envelopes and concealed behind the Chief Investigators back and she was asked to chose an envelope. The number on the card was assigned to centre C in the 2nd pair and the opposite assignment was given to centre D. This process was repeated for all 28 pairs.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Estimations:
Estimation of the required sample size was based on achieving a 24% reduction in the total number of melanocytic naevi of all sizes and a 30% reduction in melanocytic naevi 2+ mm in diameter by four years of age. This choice was based on reducing the prevalence of melanocytic naevi at age four to that expected for four year-old children raised in the less extreme UVR environment of Sydney (Kelly et al 1994; Harrison et al 1994). In order to detect a 24% reduction in mean total melanocytic naevi (mean number of nevi: 52.3 in Townsville, 40 in Sydney) by age 4 with a power of 80% and a significance level of 0.05, 72 children were required in each of the two groups (standard deviation SD 26.0). To detect a 30% reduction in the mean number of melanocytic naevi 2+ mm in diameter (mean number of naevi: 12.7 in Townsville, 8.9 in Sydney) by age four with a power of 80% and a significance level of 0.05, 110 children were required in each group (SD 10.0). Thus, the study was planned to prevent the development of a mean number of 12.3 incident melanocytic naevi of all sizes and 3.8 incident naevi 2+ mm in diameter (median values: 12 and 3, respectively) over a three-year follow-up period.

In addition, a body-site specific hypothesis was formulated based on preventing a mean of 3.8 naevi (25% reduction; median value 3.75; SD 10.0) on the arms in a three-year period (required sample size: 110 children per group assuming the same specifications as for the two other hypotheses).

Sample size calculation (adjusted for multiple testing of the main hypotheses; adjusted for violation of normality assumptions; adjusted for the design effect of cluster sampling approach (design effect = 1.5)) estimated a necessary sample size of n=230 children per group. As the population of Townsville is transient, the sample size was inflated to account for loss-to-follow up during the three-year study period.

Evaluation of the data:
Categorical data will be described as percentages. Depending on the distribution, numerical data were summarised as mean value and standard deviation (SD) or median value and inter-quartile range (IQR). Comparisons between day-care centres were made using Chi-square tests and non-parametric Wilcoxon tests. Baseline comparisons between children attending intervention and control centres used Chi-square tests, non-parametric Wilcoxon tests, and t-tests, as did baseline comparisons between children who were and were not subsequently lost to follow-up. Comparisons of sun-related behaviours within day-care centre units and of children’s baseline characteristics were adjusted for the cluster effects of the day-care centres. For these cluster-adjusted comparisons, skewed numerical data were logarithmically transformed, resulting in approximately normal distributions.

The outcome measures calculated were: the incidence rate of MN per month of follow-up; the number of incident MN at follow-up; and the number of incident MN on sun-exposed body sites at follow-up.

At final follow-up the primary (total number of incident melanocytic naevi) and secondary outcome measures (number of incident melanocytic naevi at sun-protective body-sites) will be compared between intervention and control children using (1) non-parametric Wilcoxon tests, (2) cluster-adjusted Wald-tests comparing mean values of logarithmically transformed measures, and (3) cluster adjusted multiple regression analyses of logarithmically transformed measures to adjust for confounding variables. A characteristic will be considered to be a confounder when it changes the estimated coefficient of the original regression model by more than 5%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/1999
Date of last participant enrolment
Anticipated
Actual
12/07/2002
Date of last data collection
Anticipated
Actual
1/06/2005
Sample size
Target
500
Accrual to date
Final
749
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 10122 0
4810 - Belgian Gardens
Recruitment postcode(s) [2] 10123 0
4810 - Cape Cleveland
Recruitment postcode(s) [3] 10126 0
4810 - Castle Hill
Recruitment postcode(s) [4] 10125 0
4810 - North Ward
Recruitment postcode(s) [5] 10124 0
4810 - Pallarenda
Recruitment postcode(s) [6] 10127 0
4810 - Railway Estate
Recruitment postcode(s) [7] 10128 0
4810 - Rowes Bay
Recruitment postcode(s) [8] 10129 0
4810 - Shelly Beach
Recruitment postcode(s) [9] 10130 0
4810 - South Townsville
Recruitment postcode(s) [10] 10155 0
4810 - Townsville City
Recruitment postcode(s) [11] 10131 0
4811 - Cluden
Recruitment postcode(s) [12] 10132 0
4811 - Idalia
Recruitment postcode(s) [13] 10133 0
4811 - Oak Valley
Recruitment postcode(s) [14] 10134 0
4811 - Oonoonba
Recruitment postcode(s) [15] 10135 0
4811 - Stuart
Recruitment postcode(s) [16] 10136 0
4811 - Wulguru
Recruitment postcode(s) [17] 10137 0
4812 - Currajong
Recruitment postcode(s) [18] 10138 0
4812 - Gulliver
Recruitment postcode(s) [19] 10139 0
4812 - Hermit Park
Recruitment postcode(s) [20] 10140 0
4812 - Hyde Park
Recruitment postcode(s) [21] 10142 0
4812 - Mundingburra
Recruitment postcode(s) [22] 10143 0
4812 - Mysterton
Recruitment postcode(s) [23] 10144 0
4812 - Pimlico
Recruitment postcode(s) [24] 10145 0
4812 - Rosslea
Recruitment postcode(s) [25] 10146 0
4814 - Aitkenvale
Recruitment postcode(s) [26] 10147 0
4814 - Annandale
Recruitment postcode(s) [27] 10148 0
4814 - Cranbrook
Recruitment postcode(s) [28] 10149 0
4814 - Douglas
Recruitment postcode(s) [29] 10150 0
4814 - Garbutt
Recruitment postcode(s) [30] 10151 0
4814 - Heatley
Recruitment postcode(s) [31] 10152 0
4814 - Mount Louisa
Recruitment postcode(s) [32] 10153 0
4814 - Murray
Recruitment postcode(s) [33] 10158 0
4814 - Vincent
Recruitment postcode(s) [34] 10156 0
4815 - Condon
Recruitment postcode(s) [35] 10157 0
4815 - Kelso
Recruitment postcode(s) [36] 10159 0
4815 - Rasmussen
Recruitment postcode(s) [37] 10160 0
4816 - Alligator Creek
Recruitment postcode(s) [38] 10161 0
4816 - Balgal Beach
Recruitment postcode(s) [39] 10162 0
4817 - Alice River
Recruitment postcode(s) [40] 10163 0
4817 - Bohle Plains
Recruitment postcode(s) [41] 10164 0
4817 - Hervey Range
Recruitment postcode(s) [42] 10165 0
4817 - Kirwan
Recruitment postcode(s) [43] 10168 0
4818 - Black River
Recruitment postcode(s) [44] 10169 0
4818 - Bluewater
Recruitment postcode(s) [45] 10172 0
4818 - Burdell
Recruitment postcode(s) [46] 10173 0
4818 - Bushland Beach
Recruitment postcode(s) [47] 10174 0
4818 - Deeragun
Recruitment postcode(s) [48] 10175 0
4818 - Jensen
Recruitment postcode(s) [49] 10176 0
4818 - Mount Low
Recruitment postcode(s) [50] 10177 0
4818 - Saunders Beach
Recruitment postcode(s) [51] 10178 0
4818 - Yabulu

Funding & Sponsors
Funding source category [1] 291857 0
Government body
Name [1] 291857 0
National Health and Medical Research Council
Country [1] 291857 0
Australia
Funding source category [2] 291858 0
Charities/Societies/Foundations
Name [2] 291858 0
The Parkes Bequest to James Cook University
Country [2] 291858 0
Australia
Funding source category [3] 291859 0
Government body
Name [3] 291859 0
Queensland Health
Country [3] 291859 0
Australia
Funding source category [4] 293169 0
Charities/Societies/Foundations
Name [4] 293169 0
Cancer Council Queensland
Country [4] 293169 0
Australia
Primary sponsor type
Individual
Name
Dr Simone Lee Harrison
Address
Dr Simone Lee Harrison
Skin Cancer Research Group
School of Public Health & Tropical Medicine
James Cook University
1 James Cook Drive
Douglas Townsville
Queensland 4811
Country
Australia
Secondary sponsor category [1] 290523 0
Individual
Name [1] 290523 0
Dr Petra Buttner
Address [1] 290523 0
Dr Petra Buttner
Skin Cancer Research Group
School of Public Health & Tropical Medicine
James Cook University
1 James Cook Drive
Douglas Townsville
Queensland 4811
Country [1] 290523 0
Australia
Secondary sponsor category [2] 290524 0
University
Name [2] 290524 0
James Cook University
Address [2] 290524 0
School of Public Health & Tropical Medicine and
JCU Research Services
James Cook University
1 James Cook Drive
Douglas Townsville
Queensland 4811
Country [2] 290524 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293368 0
James Cook University Human Research Ethics Committee
Ethics committee address [1] 293368 0
James Cook University Human Research Ethics Committee
JCU Research Services
James Cook University
1 James Cook Drive
Townsville Queensland 4811
Ethics committee country [1] 293368 0
Australia
Date submitted for ethics approval [1] 293368 0
01/09/1998
Approval date [1] 293368 0
15/10/1998
Ethics approval number [1] 293368 0
H804

Summary
Brief summary
This is the first RCT to evaluate the efficacy of sun-protective clothing in reducing the rate of development of melanocytic naevi (pigmented moles: a major risk factor for melanoma) in early childhood.

The proposed prospective cluster randomised intervention trial aims to determine whether reducing sun exposure, primarily through the use of sun-protective clothing can delay the development of a significant proportion of the melanocytic naevi which develop in early childhood, and have been shown in numerous case-control studies to be a major risk factor for lifetime melanoma risk.

More specifically, we aim to:

1. determine whether regularly wearing sun-protective clothing can reduce the number of new melanocytic naevi developing on the body during 3 years of follow-up;

2. determine whether regularly wearing sun-protective clothing can reduce the rate of acquisition of melanocytic naevi on those body-sites protected by study clothing (i.e. upper arms, posterior neck, trunk and thighs).


Trial website
Trial related presentations / publications
Publications:

Harrison SL, Buettner PG, MacLennan R. The North Queensland sun-safe clothing study: Design and baseline results of a randomized trial to determine the effectiveness of sun-protective clothing in preventing melanocytic nevi. Am J Epidemiol 2005;161(6):536-45.


Published Conference Abstract:

Harrison SL, Buettner PG, MacLennan R, Woosnam J, Hutton L. Baseline results of a unique randomised controlled trial to determine whether the development of melanocytic naevi (moles) in early childhood can be prevented. Tropical Health and Cancer Research in Clinical Practice. Joint Australasian College of Tropical Medicine (ACTM) and North Queensland Centre for Clinical Research (NQCCR) Meeting. Annals of the ACTM 2007;8(1):27-8.


S Harrison, Buettner PG, MacLennan R, Woosnam J, Hutton L, Nowak M. Sun-safe clothing helps to prevent the development of pigmented moles - Results of a randomised control trial in young Australian children. Annals of the ACTM 2010;11(2):49-50.

Other conference presentations:

Harrison S, Buettner P, Nowak M, Woosnam J, Hutton L, MacLennan R. Preventing pigmented moles in children: Results of an RCT in young children from QLD. Under the Queensland Sun Symposium coordinated by the Skin Cancer Prevention Working Group. Royal Brisbane Hospital, 27 July 2010.


SL Harrison, PG Buettner, R MacLennan. Sun-protective clothing slows the rate of development of melanocytic naevi (pigmented moles) in very young Australian children – Results of a cluster-randomised controlled trial (RCT) conducted in 25 childcare centres in Queensland, Australia. The first International Conference on UV and Skin Cancer Prevention. 3-5th May 2011, Copenhagen Denmark.
Public notes
Attachments [1] 541 541 0 0
/AnzctrAttachments/369130-Harrison Am J Epi 2005.pdf
Attachments [2] 543 543 0 0
/AnzctrAttachments/369130-369130-Harrison et al Annals ACTM 2010 p51.docx

Contacts
Principal investigator
Name 59578 0
A/Prof Simone Lee Harrison
Address 59578 0
JCU Skin Cancer Research Group
College of Public Health and Medicial and Veterinary Sciences
James Cook University
1 James Cook Drive
Douglas Townsville
Queensland 4811
Country 59578 0
Australia
Phone 59578 0
+61 7 44331749
Fax 59578 0
+61 7 44331767
Email 59578 0
simone.harrison@jcu.edu.au
Contact person for public queries
Name 59579 0
A/Prof Simone Lee Harrison
Address 59579 0
JCU Skin Cancer Research Group
College of Public Health and Medicial and Veterinary Sciences
James Cook University
1 James Cook Drive
Douglas Townsville
Queensland 4811
Country 59579 0
Australia
Phone 59579 0
+61 7 44331749
Fax 59579 0
+61 7 44331767
Email 59579 0
simone.harrison@jcu.edu.au
Contact person for scientific queries
Name 59580 0
A/Prof Simone Lee Harrison
Address 59580 0
JCU Skin Cancer Research Group
College of Public Health and Medicial and Veterinary Sciences
James Cook University
1 James Cook Drive
Douglas Townsville
Queensland 4811
Country 59580 0
Australia
Phone 59580 0
+61 7 44331749
Fax 59580 0
+61 7 44331767
Email 59580 0
simone.harrison@jcu.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23387Ethical approval    369130-(Uploaded-10-03-2023-20-41-24)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually
Current Study Results
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Update to Study Results
Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSun-Protective Clothing Worn Regularly during Early Childhood Reduces the Number of New Melanocytic Nevi: The North Queensland Sun-Safe Clothing Cluster Randomized Controlled Trial.2023https://dx.doi.org/10.3390/cancers15061762
N.B. These documents automatically identified may not have been verified by the study sponsor.