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Effect of topical drug made from chamomile and pumpkin on psoriasis plaque improvement

To evaluate the effectiveness of topically applied chamomile–pumpkin semi-solid formulation compared with placebo in the improvement of psoriasis plaque in patients refer to dermatology clinic of Tehran University of Medical Sciences in 2016

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016092830030N1
Enrollment
43
Registered
2016-11-05
Start date
2016-10-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

psoriasis. Psoriasis

Interventions

Intervention 1: Intervention group: semi-solid formulation (combination of chamomile oil and pumpkin oil in a ratio of 1 to 1) topical treatment twice daily for 4 weeks. Intervention 2: Control group:
Treatment - Drugs
Placebo
Intervention group: semi-solid formulation (combination of chamomile oil and pumpkin oil in a ratio of 1 to 1) topical treatment twice daily for 4 weeks
Control group: Liquid paraffin with 0.1 percent chamomile essence, topical treatment twice daily for 4 weeks

Sponsors

Vice chancellor for research, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 60 Years

Inclusion criteria

Inclusion criteria: Main Inclusion criteria: Patients with mild to moderate Psoriasis (less than 10 percent of body surface area); diagnosed by a dermatologist; aged 2-60 years old of both sexes with at least two symmetrical psoriasis plaques in their extensor areas; Discontinuation of topical treatment for at least two weeks prior to the study; Lack of systemic treatment or phototherapy during 4 weeks prior to the study; Absence of skin infections or malignancy in the treatment area; Not using Medications that could Trigger Psoriasis like beta blockers; Taking a written consent form from the patient. Main Exclusion criteria: Lactation; Pregnancy; History of allergy to the active ingredient of the product; History of skin infection or skin malignancy in the treatment area; Allergic reaction to the drug or infection in treatment area; Need to start systemic therapy during the study; Occurrence of events During the study which cause anxiety, Stress or severe mental disturbance in patients; Unwillingness of patients to continue treatment.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Scaling, Thickness, Redness. Timepoint: Before treatment and one month later for each lesion. Method of measurement: Compare photos by dermatologist and assign a number from 0 to 8 (0 no symptoms, 2 mild, 4 moderate, 6 severe, 8 very severe) to each of these signs.;PSI score. Timepoint: Before treatment and one month later for each lesion. Method of measurement: The sum of redness, thickness and scaling score.

Secondary

MeasureTime frame
Photography from lesions. Timepoint: Before treatment and one month later for each lesion. Method of measurement: Canon SX60 HS, with 65x zoom and 21-1365 mm eq lens and resolution 17 Megapixels.;Patient and physician overall estimation of treatment success rate. Timepoint: Before treatment and one month later for each lesion. Method of measurement: At the end of the study, both the dermatologist and patient will determine their estimation of improvement rate in each groups of lesions by assigning a number from 0 to ± 100. These numbers will be analyzed in a qualitative manner: negative number: worsening, 0: unchanged, (0-25 %): mild improvement, [25-50%): moderate improvement), [50-75%): high improvement, [75-100%): very high improvement, 100%: full recovery.;Evaluation of possible side effects of formulation and placebo. Timepoint: Two weeks and a month after treatment. Method of measurement: History taking and photography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSima Kolahdooz

Tehran University of Medical Sciences

simakolahdooz@yahoo.com+98 21 6697 0869

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 23, 2026