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
Scientific
79 Taleghani Avenue
Tehran
14166
Iran
| Phone | +98 21 8978190 |
|---|---|
| firozali@sina.tums.ac.ir |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Pimecrolimus 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 20/01/2005 |
| Completion date | 31/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | Patients with facial seborrheic dermatitis older than 8 years. |
| Key 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 |
| Date of first enrolment | 20/01/2005 |
| Date of final enrolment | 31/07/2005 |
Locations
Countries of recruitment
- Iran
Study participating centre
79 Taleghani Avenue
Tehran
14166
Iran
14166
Iran
Sponsor information
Tehran University of Medical Sciences (Iran) - Center for Research and Training in Skin Diseases and Leprosy
Hospital/treatment centre
Hospital/treatment centre
79 Taleghani Avenue
Tehran
14166
Iran
| Website | http://www.tums.ac.ir/english/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
