NCT06397664

Brief Summary

Background: Skin conditions are common in young people and are known to adversely affect emotional well-being and quality of life in a range of ways, including negative impact on intimate relationships. However, despite its importance, it has been shown that dermatology consultations rarely address issues like genital skin involvement or sexual dysfunction. Furthermore, there is currently very little data on the scale of the problem, risk factors, psychological impact of skin on sexual function or understanding of the most appropriate ways to manage it in this age group. Research aims: The Dermatology department at Oxford University Hospitals National Health Service Trust (Oxford, United Kingdom) have already set up an award-winning specialist dermatology service for young people with embedded psychological support. This study further explores how services can be improved by evaluating the impact of chronic skin conditions on quality of life and sexual dysfunction in adolescents. By identifying the associated risk factors, recommendations can be made to effectively meet the physical and mental health needs of adolescents. Design and methods: The study will gain perspectives from follow-up patients aged 17 - 25 years seen by the Dermatology departments in Oxford University Hospitals National Health Service Trust (Oxford, United Kingdom). They will complete an online anonymous survey to share how their skin condition affects their quality of life, including sex and intimacy, and how services can be improved to meet their needs. In-depth interviews will then be conducted in those who volunteer, to better understand the nuances of unmet needs. Participation is voluntary. Dissemination: Results of the research will be disseminated by national and international conferences, publications in academic dermatology journals and collaborations with other NHS departments. Improvements will be made to the local adolescent dermatology service as a result and shared via local meetings and posters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

April 29, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

April 24, 2024

Last Update Submit

January 10, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Scores from the modified T-QOL (Teenager's Quality of Life Index) to 1 year

    T-QOL is modified to 1 year to reflect the impact of chronic skin conditions. Scores range from 0 (least impairment on quality of life) to 36 (greatest impairment on quality of life). It is self-reported and validated.

    Baseline (Retrospective study)

  • Scores from the IIEF (International Index of Erectile Function)

    IIEF reflects 5 domains - male erectile function (maximum score 30) and intercourse satisfaction (maximum score 15), orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction (maximum scores of 10). Low scores correlate with worse outcomes. It is self-reported and validated.

    Baseline (Retrospective study)

  • Scores from the FSFI (Female Sexual Function Index)

    FSFI reflects 6 domains - female sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. All domains have a maximum score of 6 and can be totalled. Low scores correlate with worse outcomes. It is self-reported and validated.

    Baseline (Retrospective study)

  • Scores from the PHQ-9 (Patient Health Questionnaire)

    PHQ-9 is a diagnostic tool to monitor depression severity. Scores range from 0 (no depression) to 27 (severe depression). It is self-reported and validated.

    Baseline (Retrospective study)

  • Scores from the GAD-2 (Generalised Anxiety Disorder 2-item)

    GAD-2 initially screens for generalised anxiety disorder. The scores range from 0 (unlikely to have GAD) to 6 (most likely to have GAD). It is self-reported and validated.

    Baseline (Retrospective study)

Secondary Outcomes (1)

  • A narrative synthesis detailing risk factors impacting sexual function in adolescents with chronic skin conditions

    Baseline (Retrospective study)

Eligibility Criteria

Age17 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants are adolescents aged 17-25 (inclusive) who have a chronic skin condition and are seen as follow-up patients under the Oxford University Hospitals National Health Service Trust Dermatology Department.

You may qualify if:

  • The participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 17-25 (inclusive).
  • Diagnosed with a long-term skin condition and seen as a follow-up patient in the clinic.
  • Recruited from Paediatric/Adolescent, General and Acne clinics under the Oxford University Hospitals National Health Service Trust Dermatology Department.
  • Fluent in English (reading and writing).

You may not qualify if:

  • No informed consent was given to participate in the study or use the data for research purposes.
  • No capacity to make an informed decision to consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Churchill Hospital, Oxford University Hospitals NHS Trust

Oxford, Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalSkin Diseases

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

April 24, 2024

First Posted

May 3, 2024

Study Start

April 29, 2024

Primary Completion

August 1, 2024

Study Completion

December 30, 2024

Last Updated

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations