Clinical trial NCT04660916: Effects of Isotretinoin on the Growth Rate and Thickness of the Nail Plate
Official title: Effects of Isotretinoin on the Morphology, Growth Rate, and Thickness of the Nail Plate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Isotretinoin
Nail Abnormality
Keywords: isotretinoin
nail growth rate
nail thickness
13-cis-retinoic acid
Lead sponsor: Balikesir University
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The lengths and thicknesses of nail plate according to months in the isotretinoin group
timeFrame: 30 days
measure: The lengths and thicknesses of nail plate according to months in the control group
timeFrame: 30 days
measure: Comparison of nail growth rate according to groups
timeFrame: 30 days
measure: Comparison of nail thickness according to groups
timeFrame: 30 days
measure: The effect of group on the change in growth rate of nail plate by time
timeFrame: 30 days
measure: The effect of group on the change in thickness of nail plate by time
timeFrame: 30 days
measure: Changes in nail growth rates by time in the isotretinoin group
timeFrame: 30 days
measure: Changes in nail thickness by time in the isotretinoin group
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Balikesir University
Study officials:
affiliation: Balıkesir Üniversitesi
name: Sinan Özçelik, MD
role: PRINCIPAL_INVESTIGATOR
References: