Efficacy and Safety of Cream Containing Fig Extract in Subacute and Chronic Eczematous Dermatitis Volunteers

NCT07867249 — Not applicable, Not yet recruiting, 20 participants, Chulalongkorn University

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Registry	NCT07867249, acronym Efficacy and s
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, supportive care
Enrollment	20 (Estimated)
Sponsor	Chulalongkorn University (Other)
Conditions	Subacute and Chronic Eczematous Dermatitis Volunteers
Interventions	Fig extract cream, Placebo cream (Other)
Dates	start 2026-10-01 (estimated), primary completion 2027-05-01 (estimated), completion 2027-05-31 (estimated), first posted 2026-10-09, last updated 2026-10-09

-Summary

This study aims to evaluate the efficacy and safety of a cream containing fig extract in volunteers with subacute and chronic eczematous dermatitis. The affected area of subacute and chronic eczematous dermatitis in each participant will be equally divided into two sections (left and right) using block randomization. One section (Area A) will receive the fig extract cream, while the other section (Area B) will receive a placebo cream as the control. All study assessments, including clinical assessments, skin parameter measurements, patient-reported outcomes, and adverse event assessments, will be performed at baseline and at 1, 2, and 3 weeks after treatment initiation.

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+Detailed description

The severity of subacute and chronic eczematous dermatitis will be assessed using the SCORAD Index and the Eczema Area and Severity Index (EASI). Clinical photographs will be taken to assess the affected area. Skin parameters, including erythema, melanin, hydration, and transepidermal water loss, will also be evaluated. Participants will additionally assess pruritus using the Visual Analogue Scale (VAS) and quality of life using the Dermatology Life Quality Index (DLQI).

+Arms and interventions

Arm	Type	Interventions	Description
Fig extract cream	Experimental	Other: Fig extract cream	Apply the assigned cream to the designated areas, twice daily, in the morning and evening, for 3 weeks.
Placebo cream	Placebo comparator	Other: Placebo cream	Apply the assigned cream to the designated areas, twice daily, in the morning and evening, for 3 weeks.

Fig extract cream (Other): Fig extract cream
Placebo cream (Other): Placebo cream

+Outcome measures

Primary outcomes

The severity of subacute and chronic eczematous dermatitis [3 weeks]: The severity of subacute and chronic eczematous dermatitis will be assessed using the SCORAD Index. The SCORAD Index ranges from 0 to 103, with higher scores indicating greater severity of eczematous dermatitis.

Secondary outcomes

Eczema Area and Severity Index (EASI) [3 weeks]: The severity of subacute and chronic eczematous dermatitis will be assessed using the Eczema Area and Severity Index (EASI). The EASI Index ranges from 0 to 72, with higher scores indicating greater severity of eczematous dermatitis.
Area of dermatitis [3 weeks]: Clinical photographs will be taken to assess the affected area, with a reduction in the affected area indicating improvement after treatment.
Erythema level [3 weeks]: Erythema level will be assessed using a Mexameter. Higher erythema levels indicate greater severity of eczematous dermatitis.
Melanin level [3 weeks]: Melanin level will be assessed using a Mexameter.Higher melanin levels indicate greater severity of eczematous dermatitis.
Skin hydration level [3 weeks]: Skin hydration level will be assessed using a Corneometer. Lower hydration levels indicate greater severity of eczematous dermatitis.
Transepidermal water loss level [3 weeks]: Transepidermal water loss level will be assessed using a Tewameter. Higher transepidermal water loss levels indicate greater severity of eczematous dermatitis.
Pruritus score [3 weeks]: Pruritus score using the Visual Analogue Scale (VAS), ranging from 0 to 10, with higher scores indicating greater severity of itching.
Quality of life score [3 weeks]: Quality of life acore using the Dermatology Life Quality Index (DLQI), with higher scores indicating a greater impact of eczematous dermatitis on quality of life.
Adverse events from using the products [3 weeks]: Adverse events will be assessed by recording the presence or absence of itching, erythema, swelling, vesicles, abnormal breathing, and asthma symptoms.
Satisfaction Score [3 weeks]: Satisfaction Score will be assessed using a numerical rating scale from 0 to 10, where 0 indicates not satisfied at all and 10 indicates very satisfied.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Male or female participants aged 18 years or older.
* Have subacute or chronic eczematous dermatitis greater than 6.25 cm²
* Have SCORAD Index score of less than 50, indicating mild to moderate dermatitis.
* Able to read and write.

Exclusion Criteria:

* Allergic to fig extract
* Have dermatitis on face, genital area, palms, or soles.
* Used topical medications for itching or oral corticosteroids within 2 weeks
* Ppregnant or breastfeeding
* Participating in other clinical research studies

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