Condition category
Cancer
Date applied
18/10/2009
Date assigned
10/12/2009
Last edited
10/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Carlos Augusto Zanardini Pereira

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Hospital Santa Casa de Curitiba (Brazil)

Sponsor details

c/o Carlos Augusto Zanardini Pereira
Department of the Dermatology Service
Praça Rui Barbosa
694
Curitba
80010-030
Brazil

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes