Assessment of the effect of phenytoin on cutaneous healing

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN96539803

Enrollment

100

Registered

2009-12-10

Start date

2007-03-16

Completion date

Unknown

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanocytic naevi Cancer Melanocytic naevi

Interventions

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 d

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Immunosuppression 2. Chronic renal insufficiency 3. Serious coagulopathies 4. Have a history of adverse effects caused by phenytoin

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026