Assessment of the effect of phenytoin on cutaneous healing

ISRCTN	ISRCTN96539803
DOI	https://doi.org/10.1186/ISRCTN96539803
Protocol serial number	N/A
Sponsor	Hospital Santa Casa de Curitiba (Brazil)
Funder	Federal University of São Paulo (Universidade Federal de São Paulo) (Brazil)

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

Department of the Dermatology Service
Hospital Santa Casa de Curitiba
Praça Rui Barbosa, 694
Curitiba
80010-030
Brazil

Study information

Primary study design	Interventional
Study design	Single centre prospective interventional non-randomised controlled clinical study
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Phenytoin
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	01/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.