Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
Ethics committee of the Federal University of São Paulo approved on the 16th March 2007 (ref: CEP 0138/07)
Study design
Single centre prospective interventional non-randomised controlled clinical study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
16/03/2007
Overall trial end date
01/05/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Immunosuppression
2. Chronic renal insufficiency
3. Serious coagulopathies
4. Have a history of adverse effects caused by phenytoin
Recruitment start date
16/03/2007
Recruitment end date
01/05/2009
Locations
Countries of recruitment
Brazil
Trial participating centre
Department of the Dermatology Service
Curitiba
80010-030
Brazil
Funders
Funder type
University/education
Funder name
Federal University of São Paulo (Universidade Federal de São Paulo) (Brazil)
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