Atopic Dermatitis (AD)Phase 1NCT07113366
Efficacy of Jelly Fig (Ficus Awkeotsang Makino) Extract for Atopic Dermatitis
A Phase 1 study testing FAE cream in people with Atopic Dermatitis (AD), run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
The study is designed to evaluate the efficacy and safety of a topical formulation containing Ficus awkeotsang Makino extract (FAE), derived from jelly fig, in participants with mild to moderate atopic dermatitis. Ficus awkeotsang is a traditional plant native to Taiwan. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- FAE cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2024to 30 Nov 2024
- Phase
- Phase 1
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥12 years at the time of enrollment
- Clinical diagnosis of atopic dermatitis (AD) according to the Hanifin and Rajka criteria
- Investigator's Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at screening
Who cannot join
- Prior treatment with biologic agents within 16 weeks before baseline
- Use of phototherapy, systemic corticosteroids, or other systemic immunosuppressants within 28 days before baseline
- Use of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 14 days before baseline
- Presence of active skin infections
- Pregnancy or breastfeeding
- Known hypersensitivity to any component of the investigational product
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Veterans General Hospital
Kaohsiung City, Kaohsiung, 813414
About this study
Official title: Improvement of Atopic Dermatitis Symptoms and Signs by Jelly Fig (Ficus Awkeotsang Makino) Extract
The study is designed to evaluate the efficacy and safety of a topical formulation containing Ficus awkeotsang Makino extract (FAE), derived from jelly fig, in participants with mild to moderate atopic dermatitis. Ficus awkeotsang is a traditional plant native to Taiwan.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- FAE cream, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAE creamDrug
Ficus awkeotsang Makino extract (FAE)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| High-dose FAE cream (5.0 mg/mL) | Active comparator | Ficus awkeotsang Makino extract (FAE) Receives: Drug: FAE cream |
| Low- dose FAE cream (1.0 mg/mL) | Active comparator | Ficus awkeotsang Makino extract (FAE) Receives: Drug: FAE cream |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving Investigator's Global Assessment (IGA) Success
IGA success is defined as achieving a score of 0 (clear) or 1 (almost clear) with a ≥2-point improvement from baseline on the 5-point IGA scale. The scale ranges from 0 (clear) to 4 (severe), with lower scores indicating less disease severity.
Unit of Measure: Percentage of participants (%)
Measured: Day 28
Secondary outcomes (3)
Change in Eczema Area and Severity Index (EASI) Score from Baseline to Days 7 and 28
The EASI score ranges from 0 to 72, with higher scores indicating more severe disease. This outcome measures the change in EASI score from baseline.
Unit of Measure: Units on a scale
Measured: Baseline, Day 7, and Day 28
Change in Peak Pruritus Numerical Rating Scale (pp-NRS) Score from Baseline to Days 7 and 28
The pp-NRS is an 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Participants rate their worst itch over the past 24 hours.
Unit of Measure: Units on a scale
Measured: Baseline, Day 7, and Day 28
Change in Body Surface Area (BSA) Affected by Atopic Dermatitis from Baseline to Days 7 and 28
This outcome measures the percentage of body surface area affected by atopic dermatitis.
Unit of Measure: Percent (%)
Measured: Baseline, Day 7, and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 May 2024
- Primary completion1 Jun 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiau-Sheng Jang, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113366
- Sponsor's protocol ID
- KSVGH24-CT3-31
- Status last verified
- May 2024
- First submitted
- 25 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Atopic Dermatitis Symptoms and Signs by Jelly Fig (Ficus Awkeotsang Makino) Extract
- ClinicalTrials.gov ID
- NCT07113366
- Acronym / sponsor ID
- KSVGH24-CT3-31
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 8 Aug 2025 (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.
The study is designed to evaluate the efficacy and safety of a topical formulation containing Ficus awkeotsang Makino extract (FAE), derived from jelly fig, in participants with mild to moderate atopic dermatitis. Ficus awkeotsang is a traditional plant native to Taiwan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-dose FAE cream (5.0 mg/mL) | Active comparator | Drug: FAE creamFicus awkeotsang Makino extract (FAE) |
| Low- dose FAE cream (1.0 mg/mL) | Active comparator | Drug: FAE creamFicus awkeotsang Makino extract (FAE) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥12 years at the time of enrollment
- Clinical diagnosis of atopic dermatitis (AD) according to the Hanifin and Rajka criteria
- Investigator's Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at screening
Key exclusion criteria (6 listed)
- Prior treatment with biologic agents within 16 weeks before baseline
- Use of phototherapy, systemic corticosteroids, or other systemic immunosuppressants within 28 days before baseline
- Use of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 14 days before baseline
- Presence of active skin infections
- Pregnancy or breastfeeding
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 |
|---|---|---|
| FAE creamFicus awkeotsang Makino extract (FAE) | Drug | High-dose FAE cream (5.0 mg/mL), Low- dose FAE cream (1.0 mg/mL) |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Proportion of Participants Achieving Investigator's Global Assessment (IGA) Success
Time frame: Day 28
IGA success is defined as achieving a score of 0 (clear) or 1 (almost clear) with a ≥2-point improvement from baseline on the 5-point IGA scale. The scale ranges from 0 (clear) to 4 (severe), with lower scores indicating less disease severity. Unit of Measure: Percentage of participants (%)
3 secondary outcomes
Change in Eczema Area and Severity Index (EASI) Score from Baseline to Days 7 and 28
Time frame: Baseline, Day 7, and Day 28
Change in Peak Pruritus Numerical Rating Scale (pp-NRS) Score from Baseline to Days 7 and 28
Time frame: Baseline, Day 7, and Day 28
Change in Body Surface Area (BSA) Affected by Atopic Dermatitis from Baseline to Days 7 and 28
Time frame: Baseline, Day 7, and Day 28
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 8 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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?
A Phase 1 study testing FAE cream in people with Atopic Dermatitis (AD), run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
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 6 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 8 Aug 2025. 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 Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of Participants Achieving Investigator's Global Assessment (IGA) Success (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2025.