PsychologicalNCT06397664

The Impact of Chronic Adolescent Skin Conditions on Sexual Health

An observational study of Psychological and Sexual Dysfunction, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 17 to 25 years
Conditions the study is for: Psychological, Sexual Dysfunction, Adolescent Development
How many people: 91 participants
Where: 1 siteUnited Kingdom
Study dates: 29 Apr 2024to 30 Dec 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 17 to 25 years
All sexes
No healthy volunteers
Child, Adult

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.

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Churchill Hospital, Oxford University Hospitals NHS Trust
Oxford, Oxford, OX3 7LE

Other trials in United Kingdom

About this study

Official title: A Quantitative and Qualitative Study on the Impact of Chronic Adolescent Skin Conditions on Sexual Health

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.

Conditions: Psychological, Sexual Dysfunction, Adolescent Development, Interaction, Social, Dermatologic Disease
Medical subject headings: Sexual Dysfunction, Physiological, Skin Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

Scores From the Modified Teenager's Quality of Life Index (T-QOL) to 1 Year
The Teenager's Quality of Life Index (T-QOL) questionnaire is a validated, self-reported measure assessing the impact of skin disease on quality of life in adolescents. For this study, the recall period was modified from 1 week to the previous 12 months to capture the impact of chronic relapsing and remitting skin conditions. Total scores range from 0 to 36, comprising three subscales: Self-image (0-16), Physical wellbeing and future aspirations (0-8), and Psychological impact and relationships (0-12). Subscale scores are summed to generate the total score. Higher scores indicate greater impairment in quality of life (worse outcome).
Measured: Baseline assessment at study enrolment, collected prospectively via participant self-report questionnaires.
Scores From the IIEF (International Index of Erectile Function)
The International Index of Erectile Function (IIEF) is a validated, self-reported measure assessing male sexual function, including erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. It comprises five domains: Erectile Function (0-30), Intercourse Satisfaction (0-15), Orgasmic Function (0-10), Sexual Desire (0-10), and Overall Satisfaction (0-10). Domain scores are summed to generate a total score (0-75). For each scale range and the total score, lower scores indicate worse sexual function, while higher scores indicate better sexual function (better outcome). Tables report mean scores ± SEM for each domain and the total score.
Measured: Baseline assessment at study enrolment, collected prospectively via participant self-report questionnaires.
Scores From the FSFI (Female Sexual Function Index)
The Female Sexual Function Index (FSFI) is a validated, self-reported measure assessing female sexual function across six domains: Sexual Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. Raw (unweighted) domain scores are reported in the tables, with the following ranges: Sexual Desire [2-10], Arousal [0-20], Lubrication [0-20], Orgasm [0-15], Satisfaction [2-15], and Pain [0-15]. Domain scores are calculated by summing item responses and applying domain-specific weighting factors, with a maximum weighted score of 6.0 per domain. Weighted domain scores are summed to produce a total score ranging from 2.0 to 36.0 reported in the tables. Higher scores, for individual scale ranges and the total score, indicate better sexual function.
Measured: Baseline assessment at study enrolment, collected prospectively via participant self-report questionnaires.
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.
Measured: Baseline assessment at study enrolment, collected prospectively via participant self-report questionnaires.
Scores From the GAD-7 (Generalised Anxiety Disorder 7-item)
GAD-7 screens for generalised anxiety disorder. The scores range from 0 (unlikely to have GAD) to 21 (most likely to have GAD).
It is self-reported and validated.
Measured: Baseline assessment at study enrolment, collected prospectively via participant self-report questionnaires.

Secondary outcomes (4)

Reduced Confidence in Pursuing Romantic or Intimate Relationships
This outcome is based on qualitative thematic analysis. Participants with different chronic inflammatory skin conditions were analysed together to explore shared experiences of chronic inflammatory disease. Individual diagnostic arms were not analysed separately due to small numbers and because the analysis focused on cross-condition themes rather than condition-specific comparisons. Therefore, Arms/Groups were combined for this outcome.
Measured: One 60-minute interview session (within 3 months from baseline survey)
Symptomatic Manifestations Impeding Intimacy
This outcome is based on qualitative thematic analysis. Participants with different chronic inflammatory skin conditions were analysed together to explore shared experiences of chronic inflammatory disease. While Arms/Groups were combined for the primary analysis, condition-specific sub-themes were examined descriptively where relevant, and are presented as sub-groups within this outcome. Formal condition-specific comparisons were not performed due to small sample sizes.
Measured: One 60-minute interview session (within 3 months from baseline survey)
Feeling Supported But Still Struggling
This outcome is based on qualitative thematic analysis. Participants with different chronic inflammatory skin conditions were analysed together to explore shared experiences of chronic inflammatory disease. Individual diagnostic arms were not analysed separately due to small numbers and because the analysis focused on cross-condition themes rather than condition-specific comparisons. Therefore, Arms/Groups were combined for this outcome.
Measured: One 60-minute interview session (within 3 months from baseline survey)
Participant Perspectives on the Need for Clinicians to Reframe Communication
This outcome is based on qualitative thematic analysis and highlights participants' perspectives on the need for clinicians to reframe communication in clinics to approach the topic of intimacy. Participants with different chronic inflammatory skin conditions were analysed together to explore shared experiences of chronic inflammatory disease. Individual diagnostic arms were not analysed separately due to small numbers and because the analysis focused on cross-condition themes rather than condition-specific comparisons. Therefore, Arms/Groups were combined for this outcome.
Measured: One 60-minute interview session (within 3 months from baseline survey)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Apr 202430 Dec 2024

First posted3 May 2024
Study start29 Apr 2024
Primary completion1 Aug 2024
Study completion30 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PsychologicalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06397664
Sponsor's protocol ID: 329926
Status last verified: Jul 2026
First submitted: 24 Apr 2024
Last updated: 26 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Quantitative and Qualitative Study on the Impact of Chronic Adolescent Skin Conditions on Sexual Health
ClinicalTrials.gov ID: NCT06397664
Acronym / sponsor ID: 329926
Conditions: Psychological, Sexual Dysfunction, Adolescent Development, Interaction, Social, Dermatologic Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Oxford University Hospitals NHS TrustUniversity, hospital or other
Study start: 29 Apr 2024 (actual)
Primary completion: 1 Aug 2024 (actual)
Study completion: 30 Dec 2024 (actual)
First posted: 3 May 2024 (actual)
Results: Posted 26 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 17 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
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.

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Scores From the Modified Teenager's Quality of Life Index (T-QOL) to 1 Year
Time frame: Baseline assessment at study enrolment, collected prospectively via participant self-report questionnaires.
The Teenager's Quality of Life Index (T-QOL) questionnaire is a validated, self-reported measure assessing the impact of skin disease on quality of life in adolescents. For this study, the recall period was modified from 1 week to the previous 12 months to capture the impact of chronic relapsing and remitting skin conditions. Total scores range from 0 to 36, comprising three subscales: Self-image (0-16), Physical wellbeing and future aspirations (0-8), and Psychological impact and relationships (0-12). Subscale scores are summed to generate the total score. Higher scores indicate greater impairment in quality of life (worse outcome).
Scores From the IIEF (International Index of Erectile Function)
Time frame: Baseline assessment at study enrolment, collected prospectively via participant self-report questionnaires.
The International Index of Erectile Function (IIEF) is a validated, self-reported measure assessing male sexual function, including erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. It comprises five domains: Erectile Function (0-30), Intercourse Satisfaction (0-15), Orgasmic Function (0-10), Sexual Desire (0-10), and Overall Satisfaction (0-10). Domain scores are summed to generate a total score (0-75). For each scale range and the total score, lower scores indicate worse sexual function, while higher scores indicate better sexual function (better outcome). Tables report mean scores ± SEM for each domain and the total score.
Scores From the FSFI (Female Sexual Function Index)
Time frame: Baseline assessment at study enrolment, collected prospectively via participant self-report questionnaires.
The Female Sexual Function Index (FSFI) is a validated, self-reported measure assessing female sexual function across six domains: Sexual Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. Raw (unweighted) domain scores are reported in the tables, with the following ranges: Sexual Desire [2-10], Arousal [0-20], Lubrication [0-20], Orgasm [0-15], Satisfaction [2-15], and Pain [0-15]. Domain scores are calculated by summing item responses and applying domain-specific weighting factors, with a maximum weighted score of 6.0 per domain. Weighted domain scores are summed to produce a total score ranging from 2.0 to 36.0 reported in the tables. Higher scores, for individual scale ranges and the total score, indicate better sexual function.
Scores From the PHQ-9 (Patient Health Questionnaire)
Time frame: Baseline assessment at study enrolment, collected prospectively via participant self-report questionnaires.
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.
Scores From the GAD-7 (Generalised Anxiety Disorder 7-item)
Time frame: Baseline assessment at study enrolment, collected prospectively via participant self-report questionnaires.
GAD-7 screens for generalised anxiety disorder. The scores range from 0 (unlikely to have GAD) to 21 (most likely to have GAD). It is self-reported and validated.

4 secondary outcomes

Reduced Confidence in Pursuing Romantic or Intimate Relationships
Time frame: One 60-minute interview session (within 3 months from baseline survey)
Symptomatic Manifestations Impeding Intimacy
Time frame: One 60-minute interview session (within 3 months from baseline survey)
Feeling Supported But Still Struggling
Time frame: One 60-minute interview session (within 3 months from baseline survey)
Participant Perspectives on the Need for Clinicians to Reframe Communication
Time frame: One 60-minute interview session (within 3 months from baseline survey)

Results and safety

Results posted to the registry on 26 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Controls	10	8
Eczema	24	21
Acne	35	24
Chronic Spontaneous Urticaria	6	6
Hidradenitis Suppurativa	7	5
Psoriasis	3	3
Lichen Sclerosis	1	1
Other Diagnosis	5	5

Primary outcome: Scores From the Modified Teenager's Quality of Life Index (T-QOL) to 1 Year

Time frame: Baseline assessment at study enrolment, collected prospectively via participant self-report questionnaires.. Mean (Standard Error). Unit: Score on a scale

Measure	Controls n = 8	Eczema n = 21	Acne n = 24	Chronic Spontaneous Urticaria n = 6	Hidradenitis Suppurativa n = 5	Psoriasis n = 3	Lichen Sclerosis n = 1	Others n = 5
T-QoL Total	5 (0.96)	20 (1.63)	15 (1.42)	16 (2.53)	20 (3.61)	15 (1.67)	12 (0.00)	18.2 (3.94)
Self-Image	3 (0.75)	10 (0.96)	9 (0.73)	9 (1.22)	10 (1.50)	9 (1.33)	7 (0.00)	11 (1.83)
Physical Wellbeing	0.38 (0.26)	4.48 (0.43)	1.50 (0.30)	3.00 (0.63)	3.60 (0.26)	3.33 (0.33)	1.00 (0.00)	2.60 (1.33)
Psychological impact and relationships	0.88 (0.30)	5.52 (0.49)	4.75 (0.57)	3.83 (0.79)	6.40 (1.29)	3.33 (0.33)	4.00 (0)	4.80 (1.56)

Population analysed: The modified Teenager's Quality of Life Index (T-QOL) was analysed only for conditions with three or more participants. Although the "Other Diagnosis" arm comprised five participants in total, each individual condition within this arm had fewer than three participants, precluding meaningful arm-level reporting.

Primary outcome: Scores From the IIEF (International Index of Erectile Function)

Time frame: Baseline assessment at study enrolment, collected prospectively via participant self-report questionnaires.. Mean (Standard Error). Unit: Score on a scale

Measure	Eczema n = 7	Acne n = 6	Hidradenitis Suppurativa n = 2	Psoriasis n = 2
Overall Satisfaction	8.00 (0.72)	8.17 (0.83)	3.50 (0.50)	8.00 (2.00)
Erectile Function	24.71 (3.66)	29.50 (0.34)	18.50 (8.50)	16.50 (13.50)
Orgasmic Function	7.86 (1.20)	9.67 (0.33)	3.00 (1.00)	5.50 (4.50)
Sexual Desire	7.14 (0.86)	7.67 (0.76)	4.50 (2.50)	6.00 (3.00)
Intercourse Satisfaction	10.86 (1.98)	12.83 (1.25)	11.00 (1.00)	7.50 (7.50)
Total Score	58.57 (7.95)	43.50 (30.50)	67.83 (2.77)	40.50 (11.50)

Population analysed: The IIEF outcome measure was analysed only for male participants who reported sexual experience. No participants in the "Controls", "Chronic Spontaneous Urticaria", "Lichen Sclerosis" or "Other Diagnosis" arms met this criterion; therefore, results for these arms are not reported.

Primary outcome: Scores From the FSFI (Female Sexual Function Index)

Time frame: Baseline assessment at study enrolment, collected prospectively via participant self-report questionnaires.. Mean (Standard Error). Unit: Scores on a scale

Measure	Controls n = 8	Eczema n = 14	Acne n = 16	Chronic Spontaneous Urticaria n = 6	Hidradenitis Suppurativa n = 3	Psoriasis n = 1	Lichen Sclerosis n = 1
Total Weighted FSFI Scores	19.75 (4.17)	15.64 (3.34)	22.00 (2.36)	25.83 (3.05)	8.00 (8.00)	27.00 (0)	29.00 (0)
Desire (Unweighted)	5.13 (0.97)	4.50 (0.86)	5.56 (0.74)	6.33 (0.95)	1.67 (1.67)	4.00 (0)	6.00 (0)
Arousal (Unweighted)	11.13 (2.57)	9.86 (2.20)	13.13 (1.50)	14.17 (2.07)	4.00 (4.00)	11.00 (0)	17.00 (0)
Lubrication (Unweighted)	12.13 (3.15)	10.00 (2.35)	15.38 (1.57)	15.67 (1.91)	6.67 (6.67)	19.00 (0)	15.00 (0)
Orgasm (Unweighted)	9.25 (2.15)	5.86 (1.55)	8.69 (1.11)	11.17 (1.70)	3.00 (3.00)	14.00 (0)	15.00 (0)
Satisfaction (Unweighted)	9.88 (1.68)	7.29 (1.54)	10.00 (1.27)	11.83 (1.22)	4.67 (4.67)	14.00 (0)	14.00 (0)
Pain (Unweighted)	4.88 (1.56)	4.5 (1.21)	6.50 (0.90)	9.50 (1.96)	1.67 (1.67)	10.00 (0)	10.00 (0)

Population analysed: Only female participants with sexual experience were included in this analysis. Therefore, the "Other Diagnosis" arm is not included in the results as no females in this arm had any sexual experience.

Primary outcome: Scores From the PHQ-9 (Patient Health Questionnaire)

Time frame: Baseline assessment at study enrolment, collected prospectively via participant self-report questionnaires.. Mean (Standard Error). Unit: score on a scale

Measure	Controls n = 8	Eczema n = 21	Acne n = 24	Chronic Spontaneous Urticaria n = 6	Hidradenitis Suppurativa n = 5	Psoriasis n = 3	Lichen Sclerosis n = 1	Others n = 5
Value	9.25 (1.97)	10.05 (1.61)	5.58 (1.17)	9.33 (2.94)	13.20 (3.65)	3.67 (1.76)	10.00 (0.00)	9.40 (3.64)

Population analysed: The PHQ-9 was analysed only for conditions with three or more participants. Although the "Other Diagnosis" arm comprised five participants in total, each individual condition within this arm had fewer than three participants, precluding meaningful arm-level reporting.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored or assessed. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Observational Cohort	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Recruitment and retention in adolescent populations may be challenging and could affect achievable sample size. The distribution of dermatologic conditions among participants may be uneven, potentially limiting planned cross-condition comparisons. The study population may not be fully demographically representative, which may affect generalisability. Available patient-reported outcome measures are not specifically validated for adolescents with chronic skin conditions.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Psychological and Sexual Dysfunction, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Scores From the Modified Teenager's Quality of Life Index (T-QOL) to 1 Year (time frame: Baseline assessment at study enrolment, collected prospectively via participant self-report questionnaires.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06397664.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.