Effects of Isotretinoin on the Growth Rate and Thickness of the Nail Plate

Isotretinoin Clinical Trial

Official title:

Effects of Isotretinoin on the Morphology, Growth Rate, and Thickness of the Nail Plate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04660916
• Other study ID #: 19AKD93
• Status: Completed
• Start date: October 22, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: December 2020
• Source: Balikesir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The nail is an important skin appendage which can provide information about the person's overall health status in addition to having several important functions such as protection, tactile sensation, grasping. Many nail abnormalities which can have considerable psychological impact are side effects of drug administration. Retinoids have various effects on nails. Although isotretinoin as a retinoid has been associated with both decreased and increased nail growth, the great majority of such associations are not evidence-based. So, it was aimed to investigate the effects of isotretinoin on morphology, growth rate, and thickness of the nail plate.

Description:

Isotretinoin has various side effects that affect many organ systems. Some side effects such as nail changes, which do not require treatment cessation, can limit the use of isotretinoin by impairing the patient's quality of life. Although it is known that isotretinoin has various effects on the nails, there is very limited data on effects of isotretinoin on the nails. Therefore, it was aimed to investigate the effect of isotretinoin on the morphology, growth rate, and thickness of the nail plate. The patients aged 18-45 that were planned to begin treatment with isotretinoin for acne in the outpatient clinic and a control group consisting of healthy volunteers are planned to be included in the study. A dermatological examination of skin and nails is conducted in all participants. Isotretinoin treatment at 0.5 mg/kg per day in 2 divided doses will be started to patients with acne. The length and thickness of nail plate are measured by digital caliper before isotretinoin treatment, and repeated during the control visits of the participants at 30 day intervals for 6 months. All the examination and measurements are carried out in both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• The patients that were planned to begin treatment with isotretinoin for acne

Exclusion Criteria:

• Having known diseases (dermatological or systemic disorders) affecting the growth rate and thickness of nail plate

• Using systemic or topical drugs with known effects on nail

• Having traumatic nail abnormalities (onychotillomania, nail biting, habit-tic deformity)

• Having no visible lunula

• Describing any trauma (including cutting or filing nails) between the two measurements

Related Conditions & MeSH terms

• Isotretinoin
• Nail Abnormality

Intervention

Drug:
• Isotretinoin
The effects of isotretinoin on morphology, growth rate, and thickness of the nail plate

Locations

Country	Name	City	State
Turkey	Balikesir University	Balikesir

Sponsors (1)

Lead Sponsor	Collaborator
Sinan Özçelik

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The lengths and thicknesses of nail plate according to months in the isotretinoin group	These are the measures of monthly nail growth rates and thicknesses of nail plate. The lengths and thicknesses of nail plate are recorded in millimeters. Results are presented as mean or median according to whether they are normally distributed or not.	30 days
Primary	The lengths and thicknesses of nail plate according to months in the control group	These are the measures of monthly nail growth rates and thicknesses of nail plate. The lengths and thicknesses of nail plate are recorded in millimeters. Results are presented as mean or median according to whether they are normally distributed or not.	30 days
Primary	Comparison of nail growth rate according to groups	This is the comparison of monthly nail growth rates according to groups. The values of nail growth rates are recorded in millimeters per month.	30 days
Primary	Comparison of nail thickness according to groups	This is the comparison of monthly nail thickness according to groups. The values of nail thickness are recorded in millimeters.	30 days
Primary	The effect of group on the change in growth rate of nail plate by time	It is investigated using repeated measures analysis of variance	30 days
Primary	The effect of group on the change in thickness of nail plate by time	It is investigated using repeated measures analysis of variance	30 days
Primary	Changes in nail growth rates by time in the isotretinoin group	It is investigated using repeated measures analysis of variance	30 days
Primary	Changes in nail thickness by time in the isotretinoin group	It is investigated using repeated measures analysis of variance	30 days