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

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

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.

Study Overview

• Status: Completed
• Conditions: Nail Abnormality; Isotretinoin
• Intervention / Treatment: Drug: Isotretinoin

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Turkey
  • Balıkesir, Turkey, 10145
    • Balikesir University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All participants who are admitted to the outpatient clinic of our tertiary referral hospital were planned to include in the study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
isotretinoin; The patients aged 18-45 that were planned to begin treatment with isotretinoin for acne	Drug: Isotretinoin; The effects of isotretinoin on morphology, growth rate, and thickness of the nail plate; Other Names: Roaccutane; Zoretanin; D10BA01
control; Healthy volunteers aged 18-45 without any diseases/drugs affecting the nail

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Changes in nail growth rates by time in the isotretinoin group	It is investigated using repeated measures analysis of variance	30 days
Changes in nail thickness by time in the isotretinoin group	It is investigated using repeated measures analysis of variance	30 days

Collaborators and Investigators

• Sponsor: Sinan Özçelik
• Investigators: Principal Investigator: Sinan Özçelik, MD, Balıkesir Üniversitesi

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2019
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: November 28, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: isotretinoin; nail growth rate; nail thickness; 13-cis-retinoic acid
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Nails, Malformed; Dermatologic Agents; Isotretinoin
• Other Study ID Numbers: 19AKD93

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No