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 Type
OBSERVATIONAL
Enrollment
40
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
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
Marmara University School of Medicine,Department of Dermatology.
Istanbul, Turkey (Türkiye)
RECRUITINGFSH Level
Evaluation FSH levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
FSH Level
Evaluation FSH levels in after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
LH Level
Evaluation LH levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
LH Level
Evaluation LH levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
Prolactin Level
Evaluation Prolactin levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
Prolactin Level
Evaluation Prolactin levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
Estrogen Level
Evaluation Estrogen levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
Estrogen Level
Evaluation Estrogen levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
Testosterone Level
Evaluation Testosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
Testosterone Level
Evaluation Testosterone levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
Free-Testosterone Level
Evaluation Free-Testosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
Free-Testosterone Level
Evaluation Free-Testosterone levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
DHEA-s Level
Evaluation DHEA-s levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
DHEA-s Level
Evaluation DHEA-s levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
SHBG Level
Evaluation SHBG levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
SHBG Level
Evaluation SHBG levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
TSH Level
Evaluation TSH levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
TSH Level
Evaluation TSH levels iafter 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
T4 Level
Evaluation T4 levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
T4 Level
Evaluation T4 levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
17-OH Progesteroone Level
Evaluation 17-OH Progesteroone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
17-OH Progesteroone Level
Evaluation 17-OH Progesteroone after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
DHEA(LCMS) Level
Evaluation DHEA(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
DHEA(LCMS) Level
Evaluation DHEA(LCMS) levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
DHEA-S(LCMS) Level
Evaluation DHEAS(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatmen
Time frame: Baseline (Before isotretinoin treatment)
DHEA-S(LCMS) Level
Evaluation DHEAS(LCMS) levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
Androstenedione Level
Evaluation Androstenedione levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
Androstenedione Level
Evaluation Androstenedione levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
Aldosterone Level
Evaluation Aldosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
Aldosterone Level
Evaluation Aldosterone levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
Testosterone(LCMS) Level
Evaluation Testosterone(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
Testosterone(LCMS) Level
Evaluation Testosterone(LCMS) levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
Dihydrotestosterone Level
Evaluation Dihydrotestosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
Dihydrotestosterone Level
Evaluation Dihydrotestosterone levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
Estradiol Level
Evaluation Estradiol levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
Estradiol Level
Evaluation Estradiol levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
17-OH Pregnenolone Level
Evaluation 17-OH Pregnenolone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
17-OH Pregnenolone Level
Evaluation 17-OH Pregnenolone levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
Androsterone Level
Evaluation Androsterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
Androsterone Level
Evaluation Androsterone levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
Cortisol Level
Evaluation Cortisol levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
Cortisol Level
Evaluation Cortisol levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
Corticosterone Level
Evaluation Corticosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
Corticosterone Level
Evaluation Corticosterone after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
11-Deoxycortisol Level
Evaluation 11-Deoxycortisol levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
11-Deoxycortisol Level
Evaluation 11-Deoxycortisol levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
Progesterone(LCMS) Level
Evaluation Progesterone(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
Progesterone(LCMS) Level
Evaluation Progesterone(LCMS) levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
21-Deoxycortisololone Level
Evaluation 21-Deoxycortisololone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
Time frame: Baseline (Before isotretinoin treatment)
21-Deoxycortisololone Level
Evaluation 21-Deoxycortisololone levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
11-Deoxycortisolone Level
Evaluation 11-Deoxycortisolone levels in Severe Acne Vulgaris patient Before isotretinoin treatmen
Time frame: Baseline (Before isotretinoin treatment)
11-Deoxycortisolone Level
Evaluation 11-Deoxycortisolone levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
Pregnenolone Level
Evaluation Pregnenolone levels in Severe Acne Vulgaris patient Before isotretinoin treatmen
Time frame: Baseline (Before isotretinoin treatment)
Pregnenolone Level
Evaluation Pregnenolone levels after 3 month of isotretinoin treatment
Time frame: 3rd month of isotretinoin treatment
Comparison of hormone levels in acne vulgaris patients and healthy group
Comparison of all hormone levels in acne vulgaris patients and healthy group
Time frame: Baseline
Menstrual İrregularity
Evaluation of side effects such as menstrual irregularity that can be seen due to isotretinoin
Time frame: 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
Time frame: 3rd month of isotretinoin treatment
Ayse Deniz Yucelten, Prof
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