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The miskin trial for holidaymakers sun protection

A factorial randomised controlled trial of the mISkin Smartphone intervention and sunscreen with SPF 15 vs. SPF 30 to prevent epidermal DNA skin damage amongst holidaymakers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN63943558
Enrollment
200
Registered
2013-02-13
Start date
2012-10-15
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sun protection behaviours amongst holidaymakers Skin and Connective Tissue Diseases Sunburn, unspecified

Interventions

Participants will be randomised to a 2 (mISkin intervention vs. waiting list control [no mISkin intervention]) x 2 (Sunscreen provision: SPF 15 vs. SPF 30) factorial design. 1. Behavioural Intervent

Sponsors

Newcastle University (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Holidaymakers from the North East of England travelling for up to two weeks 2. Age >=18 years old 3. Individuals owning an Android Smartphone, as the mISkin app is available for Android platforms only

Exclusion criteria

Exclusion criteria: 1. People with known dermatological conditions 2. People with known allergic reactions to sunlight and/or sunscreen 3. People under photosensitive drugs for whom UV exposure is undesirable 4. People experiencing ill health 5. Pregnant women 6. Non-English speakers

Design outcomes

Primary

MeasureTime frame
Skin sun damage will be assessed objectively using a reliable epithelial skin swab to test for mitochondrial DNA (mDNA) damage caused by UV exposure (Harbottle et al. 2010) before and after their holiday.

Secondary

MeasureTime frame
1. Sunscreen use(amount) measured by weighting provided sunscreen bottles at baseline and post-test 2. Sunscreen use (frequency and time-stamped patterns) measured using tri-axial accelerometers attached to the sunscreen bottles providing time and date stamped data of bottle movement sufficient to identify instances of use 3. Self-reported sun protection behaviours using the questionnaire developed by Glanz et al. (2008) (at baseline and post-test) 4. Skin damage using a UV photo taken before and after the study displaying sun damage in the form of mottled pigmentation 5. Psychological measures of knowledge, intention, attitudes, self-efficacy, social influences towards sun protection behaviours and consideration of immediate and future consequences based on standard procedures (at baseline and post-test) Internal Pilot (Feasibility) Study To ensure the feasibility of the trial procedures, we will define the period until the first 30 participants have completed the study as internal pilot study. For this internal pilot, the main outcomes are: a) acceptability (measured by completion rates and post study interviews); b) feasibility, measured by attrition rates and user activity in interacting with the mobile-phone intervention. Stop rules: If we find that more than 10 out of the first 30 participants do not accept their group allocation, measurement procedures or other aspects of the trial procedures or if the post holiday interviews identify any significant problems with the acceptability of the trial protocol we will either modify the protocol to enhance acceptability and feasibility based on the insights gained , or we will consider discontinuing the trial. If during this period no significant problems with acceptability and feasibility are detected the data from the internal pilot will become part of the main dataset and analyses as part of the trial. If any major modifications to the protocol need to be implemented, the data from the internal pilot will not

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026