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

S

Sinan Özçelik

Status

Completed

Conditions

Nail Abnormality
Isotretinoin

Treatments

Drug: Isotretinoin

Study type

Observational

Funder types

Other

Identifiers

NCT04660916
19AKD93

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

70 participants in 2 patient groups

isotretinoin
Description:
The patients aged 18-45 that were planned to begin treatment with isotretinoin for acne
Treatment:
Drug: Isotretinoin
control
Description:
Healthy volunteers aged 18-45 without any diseases/drugs affecting the nail

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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