Health TrialsbyHealthPanel

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

ConditionSubacute and Chronic Eczematous Dermatitis Volunteers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChulalongkorn University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fig extract cream

    Other intervention

    Fig extract cream

  • Placebo cream

    Other intervention

    Placebo cream

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Fig extract creamExperimental treatment 1 intervention
Group B: Placebo creamPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The severity of subacute and chronic eczematous dermatitis

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.

Time frame
3 weeks

Secondary outcomes

1

Eczema Area and Severity Index (EASI)

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.

Time frame
3 weeks
2

Area of dermatitis

Clinical photographs will be taken to assess the affected area, with a reduction in the affected area indicating improvement after treatment.

Time frame
3 weeks
3

Erythema level

Erythema level will be assessed using a Mexameter. Higher erythema levels indicate greater severity of eczematous dermatitis.

Time frame
3 weeks
4

Melanin level

Melanin level will be assessed using a Mexameter.Higher melanin levels indicate greater severity of eczematous dermatitis.

Time frame
3 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chulalongkorn University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: