EczemaACTeczemaNCT04919330
Acceptance and Commitment Therapy-based Eczema Management Programme
A study testing Family Acceptance and Commitment Therapy-based Eczema Management Programme in people with Eczema, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This pilot randomised wait-list controlled trial aims to determine the feasibility, acceptability and preliminary effects of a Family Acceptance and Commitment Therapy-based Eczema Management Programme (FACT-EMP) on the health outcomes of both children patients and their main caregivers over a 3-month… Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Eczema
- What is being tested?
- Family Acceptance and Commitment Therapy-based Eczema Management Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 Jul 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The parent-child dyads should fulfil the following criteria:
- For the child, he or she should be 6-12 years old and diagnosed with eczema by a physician as documented in the medical records.
- For the parent, he or she should be 19-65 years; either father/mother in each family who is the primary caregiver responsible for the daily care of his/her child (e.g. the same parent who accompanied the child for follow-up appointments of the study hospital at every time), living together with the target child, able to communicate in Cantonese and accessible by telephone.
Who cannot join
- 1. Any parent and/or his/her child who are currently participating in another eczema-related intervention study, or where the child has significant medical morbidities, including congenital problems, oxygen-dependent conditions, or the presence of tracheotomy, will be excluded.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Paediatrics and Adolescent Medicine, Tuen Mun Hospital
Tuenmen, New Territories
About this study
Official title: Embodying a Compassionate Self Through Acceptance and Commitment Therapy for Parents and Children With Eczema: A Family Based Eczema Management Programme
This pilot randomised wait-list controlled trial aims to determine the feasibility, acceptability and preliminary effects of a Family Acceptance and Commitment Therapy-based Eczema Management Programme (FACT-EMP) on the health outcomes of both children patients and their main caregivers over a 3-month post-intervention.
Read the detailed description
Background:
Eczema is the most common paediatric skin condition affecting 15-20% children worldwide and 30% of children in Hong Kong. The highly visible nature of eczema symptoms that deviate from the individual's idealized body image could compromise his/her sense of self, leading to feelings of body image disturbance. It has been reported that children may use their illness to avoid schools, experience low self-esteem, shame and guilt and even stigmatization. In addition, their parents experience high level of stress in caring for their children with eczema, can easily generate shame and guilt feelings if they perceive themselves not performing satisfactory parenting roles in safeguarding their child's health. One emerging therapeutic approach to managing body-image concern, psychological difficulties associated with self-criticism and shame is by fostering self-compassion.
This study is a pilot randomized controlled trial aiming at examining the effects of a family-based eczema management programme in Hong Kong utilizing Acceptance and Commitment Therapy (ACT) to foster self-compassion of parents and their children affected by eczema. It is expected that fostering self-compassion could empower the parent-child dyads in cultivating a more loving, kind and forgiving attitude towards eczema, leading to improved motivation for self-care and better health outcomes. If found effective, the programme can improve the lives of many local families with children living with eczema through addressing their unmet psychological needs. In addition, the programme can be incorporated into current service in hospitals and community settings in Hong Kong and other Chinese communities.
Aim and hypothesis to be tested:
The proposed study will use a single-blinded, pilot randomized wait-list controlled trial design to determine the feasibility, acceptability and preliminary effects of a family ACT-based eczema management programme (FACT-EMP) on the health outcomes of both parent caregivers and children with eczema over 3-month post-intervention. It is hypothesized that when compared with a wait-list control group receiving standard care, the participants of the programme can show significant improvements in:
- childhood eczema severity (primary outcome for children),
- parental eczema management (primary outcome for parents),
- parental depression, anxiety and stress,
- health-related quality of life, psychological flexibility and self-compassion of both caregivers and their children with eczema immediately at immediately and 3-month post-intervention.
Design: A randomized wait-list controlled trial
Participants: Parents and their children aged 6-12 years diagnosed with eczema
Intervention condition: The parent-child dyads will receive four weekly 2-hour sessions of FACT-EMP. In each session, a group of 7-8 parent-child dyads will receive 90 minutes of ACT, followed by 30 minutes of education related to eczema management. The dyads in the wait-list control group will be offered to receive the same intervention after the completion of all assessments of the intervention arm.
Outcomes: The primary outcome for children is childhood eczema severity, while the primary outcome for parents is parental eczema management. The secondary outcomes for children are quality of life, self-compassion and psychological flexibility, while the secondary outcomes for parents are symptoms of depression, anxiety and stress, quality of life, psychological flexibility and self-compassion. The assessments of the aforementioned outcomes will be conducted at baseline, at post-intervention and at 3-month post-intervention by trained nurses/ research staff blinded to treatment allocation.
- Conditions
- Eczema
- Being tested
- Family Acceptance and Commitment Therapy-based Eczema Management Programme, Wait-list Control Group
- Keywords
- Acceptance and Commitment Therapy, Eczema, Randomised Controlled Trial
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Acceptance and Commitment Therapy-based Eczema Management ProgrammeBehavioural
The parent-child dyads will receive four weekly 2-hour sessions of family ACT-based eczema management programme (FACT-EMP). In each session, a group of 6-8 parent-child dyads will receive 90 minutes of ACT, followed by 30 minutes of education related to eczema management. Throughout the sessions, ACT strategies will help the dyads achieve the following therapeutic processes: To weaken the rumination cycle and "fused thoughts" related to eczema with body-image concern, shame and self-criticism for extending kindness and understanding to oneself; to build self-perspective-taking when seeing one's experience as part of the larger human experience; to strengthen their stands for their values related to self-kindness with acceptance of one's experience; and to take steps to act on values while practising kindness and compassion. Same as the waitlist control, the dyads will receive routine eczema care provided by the study hospital, including medical follow-ups and nurses' consultation.
Wait-list Control GroupBehavioural
The parent-child dyads will receive routine eczema care provided by the study hospital, including medical follow-ups and nurses' consultation. To ensure equity of access to potentially effective treatment (i.e., family ACT-based eczema management programme), the dyads in the wait-list control group will receive the same programme after the completion of all assessments of the intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| ACT Group | Experimental | One four weekly 2-hour sessions of family ACT-based eczema management programme (FACT-EMP) and routine eczema care provided by the study hospital, including medical follow-ups and nurses' consultation. Receives: Behavioral: Family Acceptance and Commitment Therapy-based Eczema Management Programme |
| Wait-list Control Group | Other | Routine eczema care provided by the study hospital, including medical follow-ups and nurses' consultation Receives: Behavioral: Wait-list Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's eczema severity
The Severity scoring of atopic dermatitis (SCORAD) will be used to assess the severity of childhood eczema, including the extent and intensity of the disease, and the degree of itching and sleep disturbance (Rehal et al., 2011).
Measured: Change from baseline to 3 months post-intervention
Parent's self-efficacy of eczema management
The 29-item Chinese Version of Parental Self-Efficacy with Eczema Care Index (PASECI; Cheng et al., 2020) will be adopted to assess the parents' self-efficacy for performing eczema management tasks, managing the child's symptoms and behavior. The PASECI is arranged in 4 subscales: Managing Medication, Managing Eczema and Symptoms, Communicating with Health Professionals, and Managing Personal Challenges. Each item is scored on an 11-point Linkert scale, ranging from 0 (Cannot do at all) to 10 (Highly certain can do it). The scores of PASECI are gained by adding items up. The higher the PASECI score, the greater the parental self-efficacy in respective scales. The PASECI possessed high internal consistency (α=.97), test-retest reliability (ICC =.93-.99), and acceptable convergent validity in the Hong Kong population.
Measured: Change from baseline to 3 months post-intervention
Secondary outcomes (7)
Child's quality of life
The 10-item Children's Dermatology Life Quality Index (CDLQI; Chuh, 2003) will be used to assess the quality of life of children living with eczema. A total of six dimensions will be assessed comprising Symptoms and Feelings, Leisure, School or Holidays, Personal Relationships, Sleep, and Treatment. A 4-point scale is used, ranging from 0 (Not at all) to 3 (Very much/Prevented school). The 10-item CDLQI score is calculated by summing the scores of the 10 questions, giving a maximum of 30 and a minimum of 0. The higher the score, the greater the degree of handicap (the more quality of life is impaired). The CDLQI has high internal consistency and a strong correlation with physical-rated disease severity.
Measured: Change from baseline to 3 months post-intervention
Child's self-compassion
The 12-item Self-Compassion Scale for Children (SCS-C; Sutton et al., 2018) will be adopted to measure the self-compassion of children. A 5-point scale is used, ranging from 1 (Never) to 5 (Always). Items on the Self-Compassion Scale for Children (SCS-C) addressed each of the six components of Neff's definition of self-compassion. The items assessing self-judgment, isolation, and over-identification were reverse-scored. The SCS-C comprises negatively-worded items and positively-worded items, each with acceptable internal consistency (α = .81-.83).
Measured: Change from baseline to 3 months post-intervention
Child's psychological flexibility
The 10-item Child and Adolescent Mindfulness Measure (CAMM; Greco et al., 2011) will be adopted to measure the psychological flexibility in terms of acceptance and mindfulness of the children with a 5-point Linkert scale, ranging from 0 (Never true) to 4 (Always true). Total scores on the CAMM were computed by summing the responses to the 10 items, yielding a possible range of 0 - 40. The CAMM has good reliability (α = .78-.83) and positive correlations with quality of life, social skills, and academic performance as well as negative correlations with somatic complaints, internalizing and externalizing symptoms.
Measured: Change from baseline to 3 months post-intervention
Parent's symptoms of depression, anxiety and stress
The 21-item Depression Anxiety Stress Scales-21 (DASS-21; Lovibond et al., 1995) will be applied to evaluate the parents' states of depression, anxiety, and stress. A 4-point Linkert scale is used, ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much/most of the time) with 3 subscales consisting of Depression, Anxiety, and Stress. Higher scores indicate more frequent symptomatology. The reliabilities for the depression, anxiety, and stress subscales in the DASS-21 were .82, .88, and .90, respectively.
Measured: Change from baseline to 3 months post-intervention
Parent's quality of life.
The 28-item Parents' Index of Quality of Life in Atopic Dermatitis (PIQoL-AD; McKenna et al., 2005) will be used to assess the quality of life of parents in caring for children with eczema with a dichotomous yes/no response format, 0 = No and 1 = Yes. The total score of PIQoL-AD ranging from 0 to 28, and a high score indicates poor quality of life. The PiQoL-AD is a standardized measure possessing good internal consistency (α=.88-.93) and test-retest reliability(r=.85) in various populations.
Measured: Change from baseline to 3 months post-intervention
Parent's psychological flexibility
The 7-item Chinese version of the Acceptance and Action Questionnaire-II (AAQ-II; Chong et al., 2019) will be used to assess the psychological flexibility of the parents with a 7-point Likert scale, ranging from 1 (Never true) to 7 (Always true). The item scores are added together to create a total score (range 7 to 49). The higher the total score, the poor psychological flexibility (more psychologically inflexible), and the lower the total score, the better the psychological flexibility. The AAQ-II possessed good internal consistencies (α=.88) and test-retest reliabilities (r=.79-.81) in Hong Kong parents of children with asthma.
Measured: Change from baseline to 3 months post-intervention
Parent's self-compassion
The 26-item Self Compassion Scale (SCS; Chen et al., 2011; Neff et al., 2016) will be adopted to measure self-compassion of the parents covering six domains: Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness, and Over-Identification. An overall self-compassion score was calculated for each participant by reverse coding responses to the negatively worded items comprising self-judgment, isolation, and over-identification subscales, then calculating the means for each of the six subscales, and finally summing the means to create a total self-compassion score. The SCS has good internal reliability in Chinese and Western populations (α ≥ 0.86 in all samples).
Measured: Change from baseline to 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start3 Jul 2021
- Primary completion30 Jun 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EczemaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment; repeated-measures 2-arm randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Tuen Mun Hospital
- Responsible party
- Principal investigator, Yuen Yu CHONG, Chinese University of Hong Kong
- Investigators
- Yuen Yu CHONG, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919330
- Sponsor's protocol ID
- RG2019/2020_A_7
- Acronym
- ACTeczema
- Status last verified
- Jul 2024
- First submitted
- 4 Jun 2021
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chong YY, Chien WT, Mou HY, Leung SP, Wong OY, Lam SY. Acceptance and Commitment Therapy Eczema Management Program for Children With Eczema: A Pilot Randomised Controlled Trial. Clin Exp Allergy. 2025 Aug;55(8):701-715. doi: 10.1111/cea.70003. Epub 2025 Feb 3.
PubMed 39900107
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embodying a Compassionate Self Through Acceptance and Commitment Therapy for Parents and Children With Eczema: A Family Based Eczema Management Programme
- ClinicalTrials.gov ID
- NCT04919330
- Acronym / sponsor ID
- ACTeczema / RG2019/2020_A_7
- Conditions
- Eczema
- Keywords
- Acceptance and Commitment Therapy, Eczema, Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Tuen Mun Hospital
- Study start
- 3 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot randomised wait-list controlled trial aims to determine the feasibility, acceptability and preliminary effects of a Family Acceptance and Commitment Therapy-based Eczema Management Programme (FACT-EMP) on the health outcomes of both children patients and their main caregivers over a 3-month post-intervention.
Detailed description
Background:
Eczema is the most common paediatric skin condition affecting 15-20% children worldwide and 30% of children in Hong Kong. The highly visible nature of eczema symptoms that deviate from the individual's idealized body image could compromise his/her sense of self, leading to feelings of body image disturbance. It has been reported that children may use their illness to avoid schools, experience low self-esteem, shame and guilt and even stigmatization. In addition, their parents experience high level of stress in caring for their children with eczema, can easily generate shame and guilt feelings if they perceive themselves not performing satisfactory parenting roles in safeguarding their child's health. One emerging therapeutic approach to managing body-image concern, psychological difficulties associated with self-criticism and shame is by fostering self-compassion.
This study is a pilot randomized controlled trial aiming at examining the effects of a family-based eczema management programme in Hong Kong utilizing Acceptance and Commitment Therapy (ACT) to foster self-compassion of parents and their children affected by eczema. It is expected that fostering self-compassion could empower the parent-child dyads in cultivating a more loving, kind and forgiving attitude towards eczema, leading to improved motivation for self-care and better health outcomes. If found effective, the programme can improve the lives of many local families with children living with eczema through addressing their unmet psychological needs. In addition, the programme can be incorporated into current service in hospitals and community settings in Hong Kong and other Chinese communities.
Aim and hypothesis to be tested:
The proposed study will use a single-blinded, pilot randomized wait-list controlled trial design to determine the feasibility, acceptability and preliminary effects of a family ACT-based eczema management programme (FACT-EMP) on the health outcomes of both parent caregivers and children with eczema over 3-month post-intervention. It is hypothesized that when compared with a wait-list control group receiving standard care, the participants of the programme can show significant improvements in:
- childhood eczema severity (primary outcome for children),
- parental eczema management (primary outcome for parents),
- parental depression, anxiety and stress,
- health-related quality of life, psychological flexibility and self-compassion of both caregivers and their children with eczema immediately at immediately and 3-month post-intervention.
Design: A randomized wait-list controlled trial
Participants: Parents and their children aged 6-12 years diagnosed with eczema
Intervention condition: The parent-child dyads will receive four weekly 2-hour sessions of FACT-EMP. In each session, a group of 7-8 parent-child dyads will receive 90 minutes of ACT, followed by 30 minutes of education related to eczema management. The dyads in the wait-list control group will be offered to receive the same intervention after the completion of all assessments of the intervention arm.
Outcomes: The primary outcome for children is childhood eczema severity, while the primary outcome for parents is parental eczema management. The secondary outcomes for children are quality of life, self-compassion and psychological flexibility, while the secondary outcomes for parents are symptoms of depression, anxiety and stress, quality of life, psychological flexibility and self-compassion. The assessments of the aforementioned outcomes will be conducted at baseline, at post-intervention and at 3-month post-intervention by trained nurses/ research staff blinded to treatment allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment; repeated-measures 2-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| ACT Group | Experimental | Behavioral: Family Acceptance and Commitment Therapy-based Eczema Management ProgrammeOne four weekly 2-hour sessions of family ACT-based eczema management programme (FACT-EMP) and routine eczema care provided by the study hospital, including medical follow-ups and nurses' consultation. |
| Wait-list Control Group | Other | Behavioral: Wait-list Control GroupRoutine eczema care provided by the study hospital, including medical follow-ups and nurses' consultation |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- For the child, he or she should be 6-12 years old and diagnosed with eczema by a physician as documented in the medical records.
- For the parent, he or she should be 19-65 years; either father/mother in each family who is the primary caregiver responsible for the daily care of his/her child (e.g. the same parent who accompanied the child for follow-up appointments of the study hospital at every time), living together with the target child, able to communicate in Cantonese and accessible by telephone.
Key exclusion criteria (1 listed)
- 1. Any parent and/or his/her child who are currently participating in another eczema-related intervention study, or where the child has significant medical morbidities, including congenital problems, oxygen-dependent conditions, or the presence of tracheotomy, will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Acceptance and Commitment Therapy-based Eczema Management ProgrammeThe parent-child dyads will receive four weekly 2-hour sessions of family ACT-based eczema management programme (FACT-EMP). In each session, a group of 6-8 parent-child dyads will receive 90 minutes of ACT, followed by 30 minutes of education related to eczema management. Throughout the sessions, ACT strategies will help the dyads achieve the following therapeutic processes: To weaken the rumination cycle and "fused thoughts" related to eczema with body-image concern, shame and self-criticism for extending kindness and understanding to oneself; to build self-perspective-taking when seeing one's experience as part of the larger human experience; to strengthen their stands for their values related to self-kindness with acceptance of one's experience; and to take steps to act on values while practising kindness and compassion. Same as the waitlist control, the dyads will receive routine eczema care provided by the study hospital, including medical follow-ups and nurses' consultation. | Behavioural | ACT Group |
| Wait-list Control GroupThe parent-child dyads will receive routine eczema care provided by the study hospital, including medical follow-ups and nurses' consultation. To ensure equity of access to potentially effective treatment (i.e., family ACT-based eczema management programme), the dyads in the wait-list control group will receive the same programme after the completion of all assessments of the intervention arm. | Behavioural | Wait-list Control Group |
Primary outcome
Child's eczema severity
Time frame: Change from baseline to 3 months post-intervention
The Severity scoring of atopic dermatitis (SCORAD) will be used to assess the severity of childhood eczema, including the extent and intensity of the disease, and the degree of itching and sleep disturbance (Rehal et al., 2011).
Parent's self-efficacy of eczema management
Time frame: Change from baseline to 3 months post-intervention
The 29-item Chinese Version of Parental Self-Efficacy with Eczema Care Index (PASECI; Cheng et al., 2020) will be adopted to assess the parents' self-efficacy for performing eczema management tasks, managing the child's symptoms and behavior. The PASECI is arranged in 4 subscales: Managing Medication, Managing Eczema and Symptoms, Communicating with Health Professionals, and Managing Personal Challenges. Each item is scored on an 11-point Linkert scale, ranging from 0 (Cannot do at all) to 10 (Highly certain can do it). The scores of PASECI are gained by adding items up. The higher the PASECI score, the greater the parental self-efficacy in respective scales. The PASECI possessed high internal consistency (α=.97), test-retest reliability (ICC =.93-.99), and acceptable convergent validity in the Hong Kong population.
7 secondary outcomes
Child's quality of life
Time frame: Change from baseline to 3 months post-intervention
Child's self-compassion
Time frame: Change from baseline to 3 months post-intervention
Child's psychological flexibility
Time frame: Change from baseline to 3 months post-intervention
Parent's symptoms of depression, anxiety and stress
Time frame: Change from baseline to 3 months post-intervention
Parent's quality of life.
Time frame: Change from baseline to 3 months post-intervention
Parent's psychological flexibility
Time frame: Change from baseline to 3 months post-intervention
Parent's self-compassion
Time frame: Change from baseline to 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Derived from this study: PubMed 39900107Chong YY, Chien WT, Mou HY, Leung SP, Wong OY, Lam SY. Acceptance and Commitment Therapy Eczema Management Program for Children With Eczema: A Pilot Randomised Controlled Trial. Clin Exp Allergy. 2025 Aug;55(8):701-715. doi: 10.1111/cea.70003. Epub 2025 Feb 3.
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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.
Yuen Yu CHONG, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Acceptance and Commitment Therapy-based Eczema Management Programme in people with Eczema, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 1 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 12 Jul 2024. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Child's eczema severity (time frame: Change from baseline to 3 months post-intervention). The study lists 2 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 NCT04919330, which also lists 1 linked publication.
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 12 Jul 2024.