Comparison of the efficacy of pimecrolimus 1% cream and hydrocortisone 1% cream in facial seborrheic dermatitis: a single-blind randomized clinical trial

ISRCTN ISRCTN77370654
DOI https://doi.org/10.1186/ISRCTN77370654
Secondary identifying numbers N/A
Submission date
22/01/2005
Registration date
19/04/2005
Last edited
15/02/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Alireza Firooz
Scientific

79 Taleghani Avenue
Tehran
14166
Iran

Phone +98 21 8978190
Email firozali@sina.tums.ac.ir

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesPimecrolimus 1% cream improves facial seborrheic dermatitis better than hydrocortisone 1% cream
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSeborrheic dermatitis
InterventionGroup 1: pimecrolimus 1% cream applied twice daily for 2 weeks
Group 2: hydrocortisone acetate 1% cream applied twice daily for 2 weeks
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Pimecrolimus, hydrocortisone
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date20/01/2005
Completion date31/07/2005

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit8 Years
SexBoth
Target number of participants40
Key inclusion criteriaPatients with facial seborrheic dermatitis older than 8 years.
Key exclusion criteria1. 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
Date of first enrolment20/01/2005
Date of final enrolment31/07/2005

Locations

Countries of recruitment

  • Iran

Study participating centre

79 Taleghani Avenue
Tehran
14166
Iran

Sponsor information

Tehran University of Medical Sciences (Iran) - Center for Research and Training in Skin Diseases and Leprosy
Hospital/treatment centre

79 Taleghani Avenue
Tehran
14166
Iran

Website http://www.tums.ac.ir/english/
ROR logo "ROR" https://ror.org/01c4pz451

Funders

Funder type

Hospital/treatment centre

Tehran University of Medical Sciences (Iran) - Center for Research and Training in Skin Diseases and Leprosy

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/08/2006 Yes No