Acne VulgarisNCT05903716
The Effects of Systemic Isotretinoin Treatment on Adrenal Steroid and Sex Hormones Level in Severe Acne Vulgaris
An observational study of Acne Vulgaris, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Acne vulgaris is a chronic inflammatory skin disease involving the pilosebaceous unit, affecting approximately 95% of adolescents and young adults. Follicular hyperkeratinization, increased sebum production, androgen hormones and inflammation play a role in the pathogenesis of acne. Read more about this study
- Who is it for?
- Ages 14 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Hormone and Isotretinoin
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2022to 30 Jun 2023
- 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 14 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Patients who applied to the Dermatology Outpatient Clinic with the diagnosis of severe acne vulgaris and will receive systemic isotrethionine treatment will be evaluated according to the inclusion/exclusion criteria.
Who may be able to join
- Severe to moderate acne vulgaris
- 14 - 20 Years old
- Female patients
Who cannot join
- Male patients
- Patients who received vitamin A or hormone therapy in the last 3 months
- Those with adrenal, thyroid, pituitary gland disease
- Those with psychiatric disorders
- History of drug use that causes acneiform eruption (eg, corticosteroids…)
- Acne conglobata and acne fulminans
Trial locations and contacts
1 site in 1 country.
Ayse Deniz Yucelten, Prof contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University School of Medicine,Department of Dermatology.
Istanbul
Baha Zaben, DR, zabenbaha@gmail.com
About this study
Acne vulgaris is a chronic inflammatory skin disease involving the pilosebaceous unit, affecting approximately 95% of adolescents and young adults.
Follicular hyperkeratinization, increased sebum production, androgen hormones and inflammation play a role in the pathogenesis of acne. Androgens (Testosterone, DHEA-S and DHT) play a role in the development of acne, hypertrophy of the sebaceous glands and increased sebum production. Androgen receptors are located in the basal layer of the sebaceous glands keratinocytes and they are located in the outer sheath of the hair follicle. These receptors are responsible for the proliferative action of keratinocytes.
Read more
The relationship between androgen hormones and acne in women and prepubertal children is well known. Many studies have shown a strong association between acne and hyperandrogenism in women.
Systemic isotretinoin therapy can be used in patients with severe acne vulgaris who do not respond to topical and oral antibiotic treatments.
In recent studies, it has been shown that systemic isotretinoin used in acne treatment changes many hormones such as GnRH, FSH, LH, Estrogen, Progesterone, Testosterone, TSH, T4 and Prolactin and causes side effects such as menstrual irregularity and hirsutism.
However, data on the effect of oral isotretinoin on adrenal and sex hormones are contradictory.
In this study, it was aimed to evaluate the effect of oral isotretinoin on adrenal steroid and sex hormone levels and to compare it with a healthy control.
Isotretinoin treatment is started in acne vulgaris patients at a dose of 0.5-0.8mg/kg/day. The total cumulative dose is 120 mg/kg.
At baseline and at the 3rd month of isotretinoin treatment, 17-OH Progesterone, DHEA, DHEAS, Androstenedione, Aldosterone, Testosterone, Dihydrotestosterone, Estradiol, 17-OH Pregnenolone, Androsterone, Cortisol, Corticosterone, 11-Degesterone, 21, -Deoxycortisol, Pregnenolone, 11-Deoxycorticostreone hormones will be evaluated with LCMS/MS technique.
In addition, the FSH, LH, Prolactin, Estrogen, Testosterone, free testosterone, DHEA-s, SHBG, TSH, T4 hormone levels of the patients will be evaluated by ELISA method.
In the baseline 2nd, 3rd, 4th and 6th months of the treatment and 3 months after the treatment, the patients' height, weight, body mass index measurements, VAS scoring of patient treatment satisfaction, Global Acne Severity Score, Acne Quality of Life Score, and Modified Ferriman Gallwey Score for hirsutism will be recorded.
The side effects of isotretinoin such as menstrual irregularity, increased hair growth, and cheilitis, dryness of the oral mucosa, skin dryness, dermatitis seen in patients during treatment will be recorded.
*Hormone tests were performed on 2th and 3rd days of menstruation
- Conditions
- Acne Vulgaris
- Being tested
- Hormone, Isotretinoin
- Keywords
- Isotretinoin, Adrenal steroid hormones, Sex hormones
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HormoneDiagnostic test
At baseline 17-OH Progesterone, DHEA, DHEAS, Androstenedione, Aldosterone, Testosterone, Dihydrotestosterone, Estradiol, 17-OH Pregnenolone, Androsterone, Cortisol, Corticosterone, 11-Degesterone, 21, -Deoxycortisol, Pregnenolone, 11-Deoxycorticostreone hormones will be evaluated.In addition, the FSH, LH, Prolactin, Estrogen, Testosterone, free testosterone, DHEA-s, SHBG, TSH, T4 hormone levels of the patients will be evaluated from all patients
IsotretinoinDrug
İn the 3rd month of isotretinoin treatment, 17-OH Progesterone, DHEA, DHEAS, Androstenedione, Aldosterone, Testosterone, Dihydrotestosterone, Estradiol, 17-OH Pregnenolone, Androsterone, Cortisol, Corticosterone, 11-Degesterone, 21, -Deoxycortisol, Pregnenolone, 11-Deoxycorticostreone hormones will be evaluated.In addition, the FSH, LH, Prolactin, Estrogen, Testosterone, free testosterone, DHEA-s, SHBG, TSH, T4 hormone levels of the patients will be evaluated by ELISA method
| Study group | Role | What they receive |
|---|---|---|
| Severe acne vulgaris | 40 female patients aged 14-20 years, who were diagnosed with severe to moderate acne bulgaris and will be treated with isotretinoin. Receives: Diagnostic Test: Hormone; Drug: Isotretinoin | |
| Healthy control | 40 female patients aged 14-20 years Receives: Diagnostic Test: Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
FSH Level
Evaluation FSH levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
FSH Level
Evaluation FSH levels in after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
LH Level
Evaluation LH levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
LH Level
Evaluation LH levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
Prolactin Level
Evaluation Prolactin levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
Prolactin Level
Evaluation Prolactin levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
Estrogen Level
Evaluation Estrogen levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
Estrogen Level
Evaluation Estrogen levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
Testosterone Level
Evaluation Testosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
Testosterone Level
Evaluation Testosterone levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
Free-Testosterone Level
Evaluation Free-Testosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
Free-Testosterone Level
Evaluation Free-Testosterone levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
DHEA-s Level
Evaluation DHEA-s levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
DHEA-s Level
Evaluation DHEA-s levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
SHBG Level
Evaluation SHBG levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
SHBG Level
Evaluation SHBG levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
TSH Level
Evaluation TSH levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
TSH Level
Evaluation TSH levels iafter 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
T4 Level
Evaluation T4 levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
T4 Level
Evaluation T4 levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
17-OH Progesteroone Level
Evaluation 17-OH Progesteroone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
17-OH Progesteroone Level
Evaluation 17-OH Progesteroone after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
DHEA(LCMS) Level
Evaluation DHEA(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
DHEA(LCMS) Level
Evaluation DHEA(LCMS) levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
DHEA-S(LCMS) Level
Evaluation DHEAS(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatmen
Measured: Baseline (Before isotretinoin treatment)
DHEA-S(LCMS) Level
Evaluation DHEAS(LCMS) levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
Androstenedione Level
Evaluation Androstenedione levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
Androstenedione Level
Evaluation Androstenedione levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
Aldosterone Level
Evaluation Aldosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
Aldosterone Level
Evaluation Aldosterone levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
Testosterone(LCMS) Level
Evaluation Testosterone(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
Testosterone(LCMS) Level
Evaluation Testosterone(LCMS) levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
Dihydrotestosterone Level
Evaluation Dihydrotestosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
Dihydrotestosterone Level
Evaluation Dihydrotestosterone levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
Estradiol Level
Evaluation Estradiol levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
Estradiol Level
Evaluation Estradiol levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
17-OH Pregnenolone Level
Evaluation 17-OH Pregnenolone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
17-OH Pregnenolone Level
Evaluation 17-OH Pregnenolone levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
Androsterone Level
Evaluation Androsterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
Androsterone Level
Evaluation Androsterone levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
Cortisol Level
Evaluation Cortisol levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
Cortisol Level
Evaluation Cortisol levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
Corticosterone Level
Evaluation Corticosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
Corticosterone Level
Evaluation Corticosterone after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
11-Deoxycortisol Level
Evaluation 11-Deoxycortisol levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
11-Deoxycortisol Level
Evaluation 11-Deoxycortisol levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
Progesterone(LCMS) Level
Evaluation Progesterone(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
Progesterone(LCMS) Level
Evaluation Progesterone(LCMS) levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
21-Deoxycortisololone Level
Evaluation 21-Deoxycortisololone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Measured: Baseline (Before isotretinoin treatment)
21-Deoxycortisololone Level
Evaluation 21-Deoxycortisololone levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
11-Deoxycortisolone Level
Evaluation 11-Deoxycortisolone levels in Severe Acne Vulgaris patient Before isotretinoin treatmen
Measured: Baseline (Before isotretinoin treatment)
11-Deoxycortisolone Level
Evaluation 11-Deoxycortisolone levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
Pregnenolone Level
Evaluation Pregnenolone levels in Severe Acne Vulgaris patient Before isotretinoin treatmen
Measured: Baseline (Before isotretinoin treatment)
Pregnenolone Level
Evaluation Pregnenolone levels after 3 month of isotretinoin treatment
Measured: 3rd month of isotretinoin treatment
Secondary outcomes (3)
Comparison of hormone levels in acne vulgaris patients and healthy group
Comparison of all hormone levels in acne vulgaris patients and healthy group
Measured: Baseline
Menstrual İrregularity
Evaluation of side effects such as menstrual irregularity that can be seen due to isotretinoin
Measured: 2. 4. 6. months and 3 month after treatment
Relationship between Menstrual irregularity and hormone levels
Evaluation of the relationship between menstrual irregularity and changes in hormone levels
Measured: 3rd month of isotretinoin treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 Sep 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
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.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903716
- Sponsor's protocol ID
- 09.2022.464
- Status last verified
- Jun 2023
- First submitted
- 26 Mar 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Systemic Isotretinoin Treatment on Adrenal Steroid and Sex Hormones Level in Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT05903716
- Acronym / sponsor ID
- 09.2022.464
- Conditions
- Acne Vulgaris
- Keywords
- Isotretinoin, Adrenal steroid hormones, Sex hormones
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 15 Jun 2023 (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 vulgaris is a chronic inflammatory skin disease involving the pilosebaceous unit, affecting approximately 95% of adolescents and young adults.
Follicular hyperkeratinization, increased sebum production, androgen hormones and inflammation play a role in the pathogenesis of acne. Androgens (Testosterone, DHEA-S and DHT) play a role in the development of acne, hypertrophy of the sebaceous glands and increased sebum production. Androgen receptors are located in the basal layer of the sebaceous glands keratinocytes and they are located in the outer sheath of the hair follicle. These receptors are responsible for the proliferative action of keratinocytes.
The relationship between androgen hormones and acne in women and prepubertal children is well known. Many studies have shown a strong association between acne and hyperandrogenism in women.
Systemic isotretinoin therapy can be used in patients with severe acne vulgaris who do not respond to topical and oral antibiotic treatments.
In recent studies, it has been shown that systemic isotretinoin used in acne treatment changes many hormones such as GnRH, FSH, LH, Estrogen, Progesterone, Testosterone, TSH, T4 and Prolactin and causes side effects such as menstrual irregularity and hirsutism.
However, data on the effect of oral isotretinoin on adrenal and sex hormones are contradictory.
In this study, it was aimed to evaluate the effect of oral isotretinoin on adrenal steroid and sex hormone levels and to compare it with a healthy control.
Isotretinoin treatment is started in acne vulgaris patients at a dose of 0.5-0.8mg/kg/day. The total cumulative dose is 120 mg/kg.
At baseline and at the 3rd month of isotretinoin treatment, 17-OH Progesterone, DHEA, DHEAS, Androstenedione, Aldosterone, Testosterone, Dihydrotestosterone, Estradiol, 17-OH Pregnenolone, Androsterone, Cortisol, Corticosterone, 11-Degesterone, 21, -Deoxycortisol, Pregnenolone, 11-Deoxycorticostreone hormones will be evaluated with LCMS/MS technique.
In addition, the FSH, LH, Prolactin, Estrogen, Testosterone, free testosterone, DHEA-s, SHBG, TSH, T4 hormone levels of the patients will be evaluated by ELISA method.
In the baseline 2nd, 3rd, 4th and 6th months of the treatment and 3 months after the treatment, the patients' height, weight, body mass index measurements, VAS scoring of patient treatment satisfaction, Global Acne Severity Score, Acne Quality of Life Score, and Modified Ferriman Gallwey Score for hirsutism will be recorded.
The side effects of isotretinoin such as menstrual irregularity, increased hair growth, and cheilitis, dryness of the oral mucosa, skin dryness, dermatitis seen in patients during treatment will be recorded.
*Hormone tests were performed on 2th and 3rd days of menstruation
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe acne vulgaris | – | Diagnostic Test: Hormone, Drug: Isotretinoin40 female patients aged 14-20 years, who were diagnosed with severe to moderate acne bulgaris and will be treated with isotretinoin. |
| Healthy control | – | Diagnostic Test: Hormone40 female patients aged 14-20 years |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients who applied to the Dermatology Outpatient Clinic with the diagnosis of severe acne vulgaris and will receive systemic isotrethionine treatment will be evaluated according to the inclusion/exclusion criteria.
Key inclusion criteria (3 listed)
- Severe to moderate acne vulgaris
- 14 - 20 Years old
- Female patients
Key exclusion criteria (6 listed)
- Male patients
- Patients who received vitamin A or hormone therapy in the last 3 months
- Those with adrenal, thyroid, pituitary gland disease
- Those with psychiatric disorders
- History of drug use that causes acneiform eruption (eg, corticosteroids…)
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 |
|---|---|---|
| HormoneAt baseline 17-OH Progesterone, DHEA, DHEAS, Androstenedione, Aldosterone, Testosterone, Dihydrotestosterone, Estradiol, 17-OH Pregnenolone, Androsterone, Cortisol, Corticosterone, 11-Degesterone, 21, -Deoxycortisol, Pregnenolone, 11-Deoxycorticostreone hormones will be evaluated.In addition, the FSH, LH, Prolactin, Estrogen, Testosterone, free testosterone, DHEA-s, SHBG, TSH, T4 hormone levels of the patients will be evaluated from all patients | Diagnostic test | Healthy control, Severe acne vulgaris |
| Isotretinoinİn the 3rd month of isotretinoin treatment, 17-OH Progesterone, DHEA, DHEAS, Androstenedione, Aldosterone, Testosterone, Dihydrotestosterone, Estradiol, 17-OH Pregnenolone, Androsterone, Cortisol, Corticosterone, 11-Degesterone, 21, -Deoxycortisol, Pregnenolone, 11-Deoxycorticostreone hormones will be evaluated.In addition, the FSH, LH, Prolactin, Estrogen, Testosterone, free testosterone, DHEA-s, SHBG, TSH, T4 hormone levels of the patients will be evaluated by ELISA method | Drug | Severe acne vulgaris |
Primary outcome
FSH Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation FSH levels in Severe Acne Vulgaris patient Before isotretinoin treatment
FSH Level
Time frame: 3rd month of isotretinoin treatment
Evaluation FSH levels in after 3 month of isotretinoin treatment
LH Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation LH levels in Severe Acne Vulgaris patient Before isotretinoin treatment
LH Level
Time frame: 3rd month of isotretinoin treatment
Evaluation LH levels after 3 month of isotretinoin treatment
Prolactin Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation Prolactin levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Prolactin Level
Time frame: 3rd month of isotretinoin treatment
Evaluation Prolactin levels after 3 month of isotretinoin treatment
Estrogen Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation Estrogen levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Estrogen Level
Time frame: 3rd month of isotretinoin treatment
Evaluation Estrogen levels after 3 month of isotretinoin treatment
Testosterone Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation Testosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Testosterone Level
Time frame: 3rd month of isotretinoin treatment
Evaluation Testosterone levels after 3 month of isotretinoin treatment
Free-Testosterone Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation Free-Testosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Free-Testosterone Level
Time frame: 3rd month of isotretinoin treatment
Evaluation Free-Testosterone levels after 3 month of isotretinoin treatment
DHEA-s Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation DHEA-s levels in Severe Acne Vulgaris patient Before isotretinoin treatment
DHEA-s Level
Time frame: 3rd month of isotretinoin treatment
Evaluation DHEA-s levels after 3 month of isotretinoin treatment
SHBG Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation SHBG levels in Severe Acne Vulgaris patient Before isotretinoin treatment
SHBG Level
Time frame: 3rd month of isotretinoin treatment
Evaluation SHBG levels after 3 month of isotretinoin treatment
TSH Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation TSH levels in Severe Acne Vulgaris patient Before isotretinoin treatment
TSH Level
Time frame: 3rd month of isotretinoin treatment
Evaluation TSH levels iafter 3 month of isotretinoin treatment
T4 Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation T4 levels in Severe Acne Vulgaris patient Before isotretinoin treatment
T4 Level
Time frame: 3rd month of isotretinoin treatment
Evaluation T4 levels after 3 month of isotretinoin treatment
17-OH Progesteroone Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation 17-OH Progesteroone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
17-OH Progesteroone Level
Time frame: 3rd month of isotretinoin treatment
Evaluation 17-OH Progesteroone after 3 month of isotretinoin treatment
DHEA(LCMS) Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation DHEA(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment
DHEA(LCMS) Level
Time frame: 3rd month of isotretinoin treatment
Evaluation DHEA(LCMS) levels after 3 month of isotretinoin treatment
DHEA-S(LCMS) Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation DHEAS(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatmen
DHEA-S(LCMS) Level
Time frame: 3rd month of isotretinoin treatment
Evaluation DHEAS(LCMS) levels after 3 month of isotretinoin treatment
Androstenedione Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation Androstenedione levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Androstenedione Level
Time frame: 3rd month of isotretinoin treatment
Evaluation Androstenedione levels after 3 month of isotretinoin treatment
Aldosterone Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation Aldosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Aldosterone Level
Time frame: 3rd month of isotretinoin treatment
Evaluation Aldosterone levels after 3 month of isotretinoin treatment
Testosterone(LCMS) Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation Testosterone(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Testosterone(LCMS) Level
Time frame: 3rd month of isotretinoin treatment
Evaluation Testosterone(LCMS) levels after 3 month of isotretinoin treatment
Dihydrotestosterone Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation Dihydrotestosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Dihydrotestosterone Level
Time frame: 3rd month of isotretinoin treatment
Evaluation Dihydrotestosterone levels after 3 month of isotretinoin treatment
Estradiol Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation Estradiol levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Estradiol Level
Time frame: 3rd month of isotretinoin treatment
Evaluation Estradiol levels after 3 month of isotretinoin treatment
17-OH Pregnenolone Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation 17-OH Pregnenolone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
17-OH Pregnenolone Level
Time frame: 3rd month of isotretinoin treatment
Evaluation 17-OH Pregnenolone levels after 3 month of isotretinoin treatment
Androsterone Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation Androsterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Androsterone Level
Time frame: 3rd month of isotretinoin treatment
Evaluation Androsterone levels after 3 month of isotretinoin treatment
Cortisol Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation Cortisol levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Cortisol Level
Time frame: 3rd month of isotretinoin treatment
Evaluation Cortisol levels after 3 month of isotretinoin treatment
Corticosterone Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation Corticosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Corticosterone Level
Time frame: 3rd month of isotretinoin treatment
Evaluation Corticosterone after 3 month of isotretinoin treatment
11-Deoxycortisol Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation 11-Deoxycortisol levels in Severe Acne Vulgaris patient Before isotretinoin treatment
11-Deoxycortisol Level
Time frame: 3rd month of isotretinoin treatment
Evaluation 11-Deoxycortisol levels after 3 month of isotretinoin treatment
Progesterone(LCMS) Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation Progesterone(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Progesterone(LCMS) Level
Time frame: 3rd month of isotretinoin treatment
Evaluation Progesterone(LCMS) levels after 3 month of isotretinoin treatment
21-Deoxycortisololone Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation 21-Deoxycortisololone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
21-Deoxycortisololone Level
Time frame: 3rd month of isotretinoin treatment
Evaluation 21-Deoxycortisololone levels after 3 month of isotretinoin treatment
11-Deoxycortisolone Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation 11-Deoxycortisolone levels in Severe Acne Vulgaris patient Before isotretinoin treatmen
11-Deoxycortisolone Level
Time frame: 3rd month of isotretinoin treatment
Evaluation 11-Deoxycortisolone levels after 3 month of isotretinoin treatment
Pregnenolone Level
Time frame: Baseline (Before isotretinoin treatment)
Evaluation Pregnenolone levels in Severe Acne Vulgaris patient Before isotretinoin treatmen
Pregnenolone Level
Time frame: 3rd month of isotretinoin treatment
Evaluation Pregnenolone levels after 3 month of isotretinoin treatment
3 secondary outcomes
Comparison of hormone levels in acne vulgaris patients and healthy group
Time frame: Baseline
Menstrual İrregularity
Time frame: 2. 4. 6. months and 3 month after treatment
Relationship between Menstrual irregularity and hormone levels
Time frame: 3rd month of isotretinoin treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
Ayse Deniz Yucelten, Prof contact
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, run by Marmara University 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baha Zaben, DR (+905459112899, zabenbaha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FSH Level (time frame: Baseline (Before isotretinoin treatment)). The study lists 54 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 15 Jun 2023.