Contact information
Type
Scientific
Primary contact
Dr Alireza Firooz
ORCID ID
Contact details
79 Taleghani Avenue
Tehran
14166
Iran
+98 21 8978190
firozali@sina.tums.ac.ir
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Pimecrolimus 1% cream improves facial seborrheic dermatitis better than hydrocortisone 1% cream
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Seborrheic dermatitis
Intervention
Group 1: pimecrolimus 1% cream applied twice daily for 2 weeks
Group 2: hydrocortisone acetate 1% cream applied twice daily for 2 weeks
Intervention type
Drug
Phase
Not Specified
Drug names
Pimecrolimus, hydrocortisone
Primary outcome measure
1. Clinical response (erythema, pruritis, scaling) at 2, 4 and 6 weeks after treatment
2. Patient's general perception about treatment result
3. Adverse events in each treatment group
Secondary outcome measures
Not provided at time of registration
Overall trial start date
20/01/2005
Overall trial end date
31/07/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with facial seborrheic dermatitis older than 8 years.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Presence of active malignancy on the facial lesion
2. Presence of any kind of active viral skin disease on the facial lesion
3. Use of oral steroids in the past two weeks
4. Use of psoralen plus ultraviolet A (PUVA), ultraviolet B (UVB), ultraviolet A (UVA), azathioprine or cyclosporin in past month
5. Application of any topical treatment in past week
6. Use of any systemic antibiotics or antifungals in past 2 weeks
7. Attending in any other research study
Recruitment start date
20/01/2005
Recruitment end date
31/07/2005
Locations
Countries of recruitment
Iran
Trial participating centre
79 Taleghani Avenue
Tehran
14166
Iran
Sponsor information
Organisation
Tehran University of Medical Sciences (Iran) - Center for Research and Training in Skin Diseases and Leprosy
Sponsor details
79 Taleghani Avenue
Tehran
14166
Iran
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Tehran University of Medical Sciences (Iran) - Center for Research and Training in Skin Diseases and Leprosy
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/16924062
Publication citations
-
Results
Firooz A, Solhpour A, Gorouhi F, Daneshpazhooh M, Balighi K, Farsinejad K, Rashighi-Firoozabadi M, Dowlati Y, Pimecrolimus cream, 1%, vs hydrocortisone acetate cream, 1%, in the treatment of facial seborrheic dermatitis: a randomized, investigator-blind, clinical trial., Arch Dermatol, 2006, 142, 8, 1066-1067, doi: 10.1001/archderm.142.8.1066.