Acne VulgarisNCT05413200
Investigation of the Effect of Oral Isotretinoin on Skin Thickness and Elasticity in Patients With Atrophic Acne Scar
An observational study of Acne Vulgaris and Isotretinoin, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Acne scar is a common complication of acne vulgaris (AV). Early and effective treatment of AV has a crucial role in managing both acne and acne scarring. Oral isotretinoin (OI) is a widely preferred agent in treating moderate and severe AV worldwide. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acne Vulgaris, Isotretinoin, Atrophic Acne Scar
- What is being tested?
- Isotretinoin
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 4 Jun 2022
- How long will I take part?
- 90 Days
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Thirty patients who applied to the Istanbul Training and Research Hospital, Dermatology Department, between November 2021 and January 2022 diagnosed with moderate and severe AV accompanied by atrophic acne scars were included in the study.
Who may be able to join
- Being over 18 years old
- Being under 65 years old
- Moderate to severe acne vulgaris with atrophic acne scars
- Absence of keloidal or hypertrophic scars
- Planning the use of oral isotretinoin in the treatment
- No additional disease
- Not smoking
- Consent to participate in the study and treatment
Who cannot join
- Using isotretinoin in the last 1 year
- Using topical or systemic medication in addition to oral isotretinoin for the treatment of acne vulgaris
- Having a keloidal or hypertrophic scar
- Being in pregnancy and lactation period
- To plan a pregnancy or are unable to adapt to contraception
- Known chronic diseases; skin cancer and other cancers, uncontrolled such as diabetes, hepatic failure/dysfunction, renal failure/dysfunction, neuromuscular diseases, autoimmune connective tissue diseases, hematological diseases, malabsorption diseases, inflammatory bowel diseases, pseudotumor cerebri, psychiatric diseases, and alcoholism.
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- Severe hypercholesterolemia (>250 mg/dL), hypertriglyceridemia (> 500 mg/dL)
- Elevated liver function tests (ALT, AST, GGT, ALP) exceeding 3 times the upper limit
- Creatine kinase elevation exceeding 5 times the upper limit
- Using regular medication for another known disease
- To smoke
- A dermatological pathology other than facial acne vulgaris. (seborrheic dermatitis, rosacea, perioral dermatitis, herpes infection, impetigo, cutaneous lupus erythematosus, solar keratosis)
- Using Vitamin A
- Those who have or will receive a blood transfusion (during treatment or within 1 month after treatment)
- Hypersensitivity to the drug's preservatives
- Unrealistic expectations from treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Research Hospital
Istanbul, 34098
About this study
Official title: Investigation of the Effect of Oral Isotretinoin on Clinical Severity, Skin Thickness, and Elasticity in Patients With Moderate to Severe Acne Vulgaris and Atrophic Acne Scar by Shear-Wave Elastography
Acne scar is a common complication of acne vulgaris (AV). Early and effective treatment of AV has a crucial role in managing both acne and acne scarring. Oral isotretinoin (OI) is a widely preferred agent in treating moderate and severe AV worldwide. It has been shown that topical retinoids can also be effective in the treatment of atrophic acne scars. However, there is no study in the literature evaluating the effectiveness of OI protocol on atrophic scars with objective data. With the developing sonoelastography technology in recent years, a quantitative, objective, and reliable examination of the elasticity of the skin and subcutaneous tissue can be provided. In this study, for a detailed and objective evaluation of the effects of OI on atrophic acne scars, we investigate the AV severity, atrophic scar grade, scar size (SS), dermis and subcutaneous tissue thickness (STT), and changes in scar and subcutaneous tissue elastic modulus (EM) in moderate and severe AV patients with atrophic acne scars by clinical observation and SWE.
Materials and Methods: It was designed as a single-center, prospective and observational study. Ethics committee approval was obtained. Thirty patients who applied to the Istanbul Training and Research Hospital, Dermatology Department, between November 2021 and January 2022 diagnosed with moderate and severe AV accompanied by atrophic acne scars were included in the study. Demographic characteristics of the patients were recorded. We started the OI with a standard dose regime. On days 0 and 90 of treatment, each patient's AV and scar severity; were evaluated with the global acne grading system (GAGS) and the Goodman and Baron Qualitative Global Scar Rating System (GSRS). On the same days, the dermal thickness (DT), STT, SS, scar, and subcutaneous tissue EM on the right and left cheeks were measured by the same experienced radiologist with SWE. Appropriate statistical methods analyzed the results.
- Conditions
- Acne Vulgaris, Isotretinoin, Atrophic Acne Scar
- Being tested
- Isotretinoin
- Keywords
- acne vulgaris, oral isotretinoin theraphy, atrophic acne scars, Shear-Wave Elastography, skin elasticity
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsotretinoinDrug
oral isotretinoin with a standard dose regime for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients diagnosed with moderate and severe AV accompanied by atrophic acne scars Receives: Drug: Isotretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline atrophic acne scar severity at 90 days
Change from baseline Goodman and Baron Qualitative Global Scar Rating System (first grade: grade 1, last grade: grade 4. Scar severity increases with increasing grade) at 90 days
Measured: Day 0-90
Change from baseline skin thickness at 90 days
Change from baseline dermal and subcutaneous tissue thickness at 90 days
Measured: Day 0-90
Change from baseline skin elasticity at 90 days
Change from baseline scar and subcutaneous tissue elasticity at 90 days
Measured: Day 0-90
Secondary outcomes (1)
Change from baseline acne vulgaris severity at 90 days
Change from baseline Global Acne Grading System (minimum score:0, maximum score: 44, severity increases with increasing score) at 90 days
Measured: Day 0-90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Nov 2021
- Primary completion7 Apr 2022
- Study completion4 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cemre Busra Turk, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413200
- Sponsor's protocol ID
- 98
- Status last verified
- Jun 2022
- First submitted
- 4 Jun 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Oral Isotretinoin on Clinical Severity, Skin Thickness, and Elasticity in Patients With Moderate to Severe Acne Vulgaris and Atrophic Acne Scar by Shear-Wave Elastography
- ClinicalTrials.gov ID
- NCT05413200
- Acronym / sponsor ID
- 98
- Conditions
- Acne Vulgaris, Isotretinoin, Atrophic Acne Scar
- Keywords
- acne vulgaris, oral isotretinoin theraphy, atrophic acne scars, Shear-Wave Elastography, skin elasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 4 Jun 2022 (actual)
- First posted
- 9 Jun 2022 (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.
Acne scar is a common complication of acne vulgaris (AV). Early and effective treatment of AV has a crucial role in managing both acne and acne scarring. Oral isotretinoin (OI) is a widely preferred agent in treating moderate and severe AV worldwide. It has been shown that topical retinoids can also be effective in the treatment of atrophic acne scars. However, there is no study in the literature evaluating the effectiveness of OI protocol on atrophic scars with objective data. With the developing sonoelastography technology in recent years, a quantitative, objective, and reliable examination of the elasticity of the skin and subcutaneous tissue can be provided. In this study, for a detailed and objective evaluation of the effects of OI on atrophic acne scars, we investigate the AV severity, atrophic scar grade, scar size (SS), dermis and subcutaneous tissue thickness (STT), and changes in scar and subcutaneous tissue elastic modulus (EM) in moderate and severe AV patients with atrophic acne scars by clinical observation and SWE.
Materials and Methods: It was designed as a single-center, prospective and observational study. Ethics committee approval was obtained. Thirty patients who applied to the Istanbul Training and Research Hospital, Dermatology Department, between November 2021 and January 2022 diagnosed with moderate and severe AV accompanied by atrophic acne scars were included in the study. Demographic characteristics of the patients were recorded. We started the OI with a standard dose regime. On days 0 and 90 of treatment, each patient's AV and scar severity; were evaluated with the global acne grading system (GAGS) and the Goodman and Baron Qualitative Global Scar Rating System (GSRS). On the same days, the dermal thickness (DT), STT, SS, scar, and subcutaneous tissue EM on the right and left cheeks were measured by the same experienced radiologist with SWE. Appropriate statistical methods analyzed the results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Drug: IsotretinoinPatients diagnosed with moderate and severe AV accompanied by atrophic acne scars |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Thirty patients who applied to the Istanbul Training and Research Hospital, Dermatology Department, between November 2021 and January 2022 diagnosed with moderate and severe AV accompanied by atrophic acne scars were included in the study.
Key inclusion criteria (8 listed)
- Being over 18 years old
- Being under 65 years old
- Moderate to severe acne vulgaris with atrophic acne scars
- Absence of keloidal or hypertrophic scars
- Planning the use of oral isotretinoin in the treatment
Key exclusion criteria (16 listed)
- Using isotretinoin in the last 1 year
- Using topical or systemic medication in addition to oral isotretinoin for the treatment of acne vulgaris
- Having a keloidal or hypertrophic scar
- Being in pregnancy and lactation period
- To plan a pregnancy or are unable to adapt to contraception
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 |
|---|---|---|
| Isotretinoinoral isotretinoin with a standard dose regime for 90 days | Drug | Patients |
Primary outcome
Change from baseline atrophic acne scar severity at 90 days
Time frame: Day 0-90
Change from baseline Goodman and Baron Qualitative Global Scar Rating System (first grade: grade 1, last grade: grade 4. Scar severity increases with increasing grade) at 90 days
Change from baseline skin thickness at 90 days
Time frame: Day 0-90
Change from baseline dermal and subcutaneous tissue thickness at 90 days
Change from baseline skin elasticity at 90 days
Time frame: Day 0-90
Change from baseline scar and subcutaneous tissue elasticity at 90 days
1 secondary outcome
Change from baseline acne vulgaris severity at 90 days
Time frame: Day 0-90
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 Jun 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acne Vulgaris and Isotretinoin, run by Istanbul Training and Research Hospital 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 8 inclusion and 16 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 Jun 2022. 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?
Change from baseline atrophic acne scar severity at 90 days (time frame: Day 0-90). The study lists 3 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 Jun 2022.