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

NCT04660916 | Completed FDA Drug

• 1 other identifier: 19AKD93
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Isotretinoin; Nail Abnormality

Keywords

isotretinoin; nail growth rate; nail thickness; 13-cis-retinoic acid

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

isotretinoin

The patients aged 18-45 that were planned to begin treatment with isotretinoin for acne

Drug: Isotretinoin

control

Healthy volunteers aged 18-45 without any diseases/drugs affecting the nail

Interventions

Isotretinoin DRUG

The effects of isotretinoin on morphology, growth rate, and thickness of the nail plate

Also known as: Roaccutane, Zoretanin, D10BA01

isotretinoin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sinan Özçelik: lead

Study Sites (1)

Balikesir University

Balıkesir, 10145, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nails, Malformed

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Sinan Özçelik, MD

  Balıkesir Üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 28, 2020
• First Posted: December 9, 2020
• Study Start: October 22, 2019
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: December 9, 2020

Record last verified: 2020-12

Locations

TU (1)