Assessment of the effect of phenytoin on cutaneous healing
| ISRCTN | ISRCTN96539803 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96539803 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/10/2009
- Registration date
- 10/12/2009
- Last edited
- 29/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Carlos Augusto Zanardini Pereira
Scientific
Scientific
Department of the Dermatology Service
Hospital Santa Casa de Curitiba
Praça Rui Barbosa, 694
Curitiba
80010-030
Brazil
Study information
| Study design | Single centre prospective interventional non-randomised controlled clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Assessment of the effect of phenytoin on cutaneous healing from excision of melanocytic nevi on the face and on the back: a single centre prospective non-randomised clinical trial |
| Study objectives | The central hypothesis of this study is that the topical use of phenytoin in cream base accelerates re-epithelialisation of the wound, after surgery of skin lesions, with less healing time and better cosmetic results compared with the use of the cream base alone, for 7, 14, 21 and 60 days post-operatively. |
| Ethics approval(s) | Ethics committee of the Federal University of São Paulo approved on the 16th March 2007 (ref: CEP 0138/07) |
| Health condition(s) or problem(s) studied | Melanocytic naevi |
| Intervention | The nevi injuries located on the face and on the back were excised with either 6 or 8 mm modified punches, in accordance with the nevus diameter, creating a superficial cutaneous wound, of the same diameter and depth in the same patient. Used for healing was a phenytoin topical cream 0.5% and cream control. One of the injuries was cared with a wound dressing with phenytoin and the other with cream (control). The dressing was replaced once a day, until the complete healing of the lesions. The full healing was defined upon the total closure of the injury without evidence of residual exudates or inflammation. The patients returned for a clinical and cosmetic evaluation and photographic documentation at 7, 14, 21 and 60 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Phenytoin |
| Primary outcome measure | For each treatment group, measured at 7, 14, 21 and 60 days: 1. Pain of treatment performed, scored on a visual analogue scale (VAS): 0 (ausente); + (mild); ++ (moderate); +++(greater) 2. Shape and thickness of the scar using the following scale: A = less than 70% elliptic and flat; B = greater than 70% circular and flat; C = less than 10% hypertrophic 3. Cosmetic outcomes; the criteria for evaluation were as follows: excellent, no noticeable scar; good, slightly noticeable scar with normochromia or hypochromia; poor, depressed scar or intense dyschromia |
| Secondary outcome measures | 1. Efficiency of the method, based on evaluations made by the physician and on the comparative photographic documentation 2. Adverse reactions; causative agents of allergic contact dermatitis was observed by the presence of erythema and vesicles The computer application was specifically developed for measuring the cutaneous wound area and scars on digital images. Afterwards, the software automatically calculated its area in mm^2. |
| Overall study start date | 16/03/2007 |
| Completion date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Bearing two or more skin lesions clinically compatible with melanocytic naevi, located in the region of the face or back of the chest 2. Cared at Hospital Santa Casa de Misericórdia in Curitiba 3. Male or female, aged 16 years and older 4. Assessing the possible need for surgical removal of nevi, when they present at least one of the following changes: 4.1. Itching 4.2. Changes in pigmentation 4.3. Inflammation 4.4. Bleeding 4.5. Located in the area of trauma 4.6. Aesthetic reasons |
| Key exclusion criteria | 1. Immunosuppression 2. Chronic renal insufficiency 3. Serious coagulopathies 4. Have a history of adverse effects caused by phenytoin |
| Date of first enrolment | 16/03/2007 |
| Date of final enrolment | 01/05/2009 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Department of the Dermatology Service
Curitiba
80010-030
Brazil
80010-030
Brazil
Sponsor information
Hospital Santa Casa de Curitiba (Brazil)
Hospital/treatment centre
Hospital/treatment centre
c/o Carlos Augusto Zanardini Pereira
Department of the Dermatology Service
Praça Rui Barbosa, 694
Curitba
80010-030
Brazil
"ROR" |
https://ror.org/01by1qv45 |
|---|
Funders
Funder type
University/education
Federal University of São Paulo (Universidade Federal de São Paulo) (Brazil)
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 | 24/08/2010 | 29/12/2020 | Yes | No |
Editorial Notes
29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
