Condition category
Skin and Connective Tissue Diseases
Date applied
22/01/2005
Date assigned
19/04/2005
Last edited
15/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.tums.ac.ir/english/

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/16924062

Publication citations

  1. 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.

Additional files

Editorial Notes