Skip to content

Evaluation of the effectiveness of topical product containing henna and turmeric with Persian medicine based formulation in patients with contact dermatitis. Triple-blind clinical trial

Comparison of the effectiveness of topical product containing henna and turmeric with a Persian medicine based formulation with placebo in patients with contact dermatitis. Triple-blind clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220321054336N1
Enrollment
33
Registered
2022-04-09
Start date
2022-05-22
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

contact dermatitis. Irritant contact dermatitis

Interventions

Intervention 1: According to traditional sources and published articles, three components of turmeric, henna and Zaravand were selected to prepare the formulation. Extraction of each ingredient is don

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 18 years and above Acute or recurrent contact dermatitis in a person with a history of mild to moderate contact dermatitis (baseline Three Item Severity score in the range of 1 to 6) • Declare the written consent of the patient to participate in the study and the desire to attend regular treatment and follow-up courses • Have a minimum score of one for the redness and itching option in the Three Item Severity score

Exclusion criteria

Exclusion criteria: Other types of dermatitis except contact dermatitis Use of topical dermatitis medications (except moisturizers) in the last 2 weeks or systemic medications in the last 4 weeks Taking steroids or systemic immunosuppressants with any indication • Pregnant and lactating women • Severe contact dermatitis (Three Item Severity = 9) • Alcohol or drug addiction • Heart disease, kidney disease or asthma • Active skin disease other than contact dermatitis • History of allergies to topical medications or cosmetics (with documentation) Tattooing, scarring, and hyperpigmentation at the lesion site History of any malignant disease or active cancer G6PD enzyme deficiency

Design outcomes

Primary

MeasureTime frame
Disease severity score on a three-item severity scale. Timepoint: Before the start of the study and2 and 4 weeks after the intervention. Method of measurement: Use a three-item intensity score(TIS).;Itching intensity score. Timepoint: Before the start of the study and2 and 4 weeks after the intervention. Method of measurement: Use Visual Analogue Scale(VAS).;Trans epidermal water loss. Timepoint: Before the start of the study and 4 weeks after the intervention. Method of measurement: Use Cutameter M P 580.;Epidermal moisture. Timepoint: Before the start of the study and 4 weeks after the intervention. Method of measurement: Use Cutameter M P 580.;Melanin content. Timepoint: Before the start of the study and 4 weeks after the intervention. Method of measurement: Use Cutameter M P 580.;Hemoglobin content. Timepoint: Before the start of the study and 4 weeks after the intervention. Method of measurement: Use Cutameter M P 580.;Sebum content. Timepoint: Before the start of the study and 4 weeks after the intervention. Method of measurement: Use Cutameter M P 580.;Temperature. Timepoint: Before the start of the study and 4 weeks after the intervention. Method of measurement: Use Cutameter M P 580.;Surface acidity of the lesion(PH). Timepoint: Before the start of the study and 4 weeks after the intervention. Method of measurement: Use Cutameter M P 580.

Secondary

MeasureTime frame
Determining the effectiveness of the studied drug in comparison with placebo on the quality of life of patients. Timepoint: 4 weeks after taking topical Persian medicine drug. Method of measurement: Use of Dermatology Life Quality Index (DLQI) questionnaire.;Determining the side effects of the studied drug. Timepoint: 4 weeks after taking topical Persian medicine drug. Method of measurement: common Terminology Criteria for Adverse Events questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShabnam Khatami

Tehran University of Medical Sciences

khatami.shabnsm.188@gmail.com+98 21 8899 3656

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026