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NCT Number: NCT04660916

Effects of Isotretinoin on the 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.

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Key information

Conditions

Isotretinoin Nail Abnormality Nails, Malformed Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Balikesir University

Balıkesir, 10145, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

isotretinoin

Drug

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

Other names: Roaccutane, Zoretanin, D10BA01

Primary outcomes

  1. The lengths and thicknesses of nail plate according to months in the isotretinoin group

    Time frame: 30 days

    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.

  2. The lengths and thicknesses of nail plate according to months in the control group

    Time frame: 30 days

    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.

  3. Comparison of nail growth rate according to groups

    Time frame: 30 days

    This is the comparison of monthly nail growth rates according to groups. The values of nail growth rates are recorded in millimeters per month.

  4. Comparison of nail thickness according to groups

    Time frame: 30 days

    This is the comparison of monthly nail thickness according to groups. The values of nail thickness are recorded in millimeters.

  5. The effect of group on the change in growth rate of nail plate by time

    Time frame: 30 days

    It is investigated using repeated measures analysis of variance

  6. The effect of group on the change in thickness of nail plate by time

    Time frame: 30 days

    It is investigated using repeated measures analysis of variance

  7. Changes in nail growth rates by time in the isotretinoin group

    Time frame: 30 days

    It is investigated using repeated measures analysis of variance

  8. Changes in nail thickness by time in the isotretinoin group

    Time frame: 30 days

    It is investigated using repeated measures analysis of variance

Sponsors and collaborators

Lead sponsor

Sinan Özçelik

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 9, 2020
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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