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

NCT ID: NCT04660916

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-22

Study Completion Date

2020-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Isotretinoin Nail Abnormality

Keywords

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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isotretinoin

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

Isotretinoin

Intervention Type DRUG

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

control

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

No interventions assigned to this group

Interventions

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Isotretinoin

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

Intervention Type DRUG

Other Intervention Names

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Roaccutane Zoretanin D10BA01

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sinan Özçelik

OTHER

Sponsor Role lead

Responsible Party

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Sinan Özçelik

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sinan Özçelik, MD

Role: PRINCIPAL_INVESTIGATOR

Balıkesir Üniversitesi

Locations

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Balikesir University

Balıkesir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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19AKD93

Identifier Type: -

Identifier Source: org_study_id