IsotretinoinNCT04660916
Effects of Isotretinoin on the Growth Rate and Thickness of the Nail Plate
An observational study of Isotretinoin and Nail Abnormality, run by Sinan Özçelik at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Isotretinoin, Nail Abnormality
- What is being tested?
- Isotretinoin
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2019to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All participants who are admitted to the outpatient clinic of our tertiary referral hospital were planned to include in the study.
Who may be able to join
- The patients that were planned to begin treatment with isotretinoin for acne
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Isotretinoin on the Morphology, 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.
Read the 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.
- Conditions
- Isotretinoin, Nail Abnormality
- Being tested
- Isotretinoin
- Keywords
- isotretinoin, nail growth rate, nail thickness, 13-cis-retinoic acid
- Medical subject headings
- Nails, Malformed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsotretinoinDrug
Also called Roaccutane, Zoretanin, D10BA01
The effects of isotretinoin on morphology, growth rate, and thickness of the nail plate
| Study group | Role | What they receive |
|---|---|---|
| isotretinoin | The patients aged 18-45 that were planned to begin treatment with isotretinoin for acne Receives: Drug: Isotretinoin | |
| control | Healthy volunteers aged 18-45 without any diseases/drugs affecting the nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 30 days
Changes in nail growth rates by time in the isotretinoin group
It is investigated using repeated measures analysis of variance
Measured: 30 days
Changes in nail thickness by time in the isotretinoin group
It is investigated using repeated measures analysis of variance
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start22 Oct 2019
- Primary completion1 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IsotretinoinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinan Özçelik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sinan Özçelik, Balikesir University
- Investigators
- Sinan Özçelik, MD, Principal investigator, Balıkesir Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660916
- Sponsor's protocol ID
- 19AKD93
- Status last verified
- Dec 2020
- First submitted
- 28 Nov 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Isotretinoin on the Morphology, Growth Rate, and Thickness of the Nail Plate
- ClinicalTrials.gov ID
- NCT04660916
- Acronym / sponsor ID
- 19AKD93
- Conditions
- Isotretinoin, Nail Abnormality
- Keywords
- isotretinoin, nail growth rate, nail thickness, 13-cis-retinoic acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sinan ÖzçelikUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isotretinoin | – | Drug: IsotretinoinThe patients aged 18-45 that were planned to begin treatment with isotretinoin for acne |
| control | – | –Healthy volunteers aged 18-45 without any diseases/drugs affecting the nail |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All participants who are admitted to the outpatient clinic of our tertiary referral hospital were planned to include in the study.
Key inclusion criteria (1 listed)
- The patients that were planned to begin treatment with isotretinoin for acne
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsotretinoinAlso: Roaccutane, Zoretanin, D10BA01The effects of isotretinoin on morphology, growth rate, and thickness of the nail plate | Drug | isotretinoin |
Primary outcome
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.
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.
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.
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.
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
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
Changes in nail growth rates by time in the isotretinoin group
Time frame: 30 days
It is investigated using repeated measures analysis of variance
Changes in nail thickness by time in the isotretinoin group
Time frame: 30 days
It is investigated using repeated measures analysis of variance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma
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Comparison of Itraconazole With Itraconazole and Isotretinoin in the Treatment Duration, Safety a n d Cure Rate in Adult Patients of Tinea Corporis/ Cruris-A Randomised Controlled Trail
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sinan Özçelik, MD principal investigator
Balıkesir Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Isotretinoin and Nail Abnormality, run by Sinan Özçelik at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The lengths and thicknesses of nail plate according to months in the isotretinoin group (time frame: 30 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.