The Effects of Systemic Isotretinoin Treatment on Adrenal Steroid and Sex Hormones Level in Severe Acne Vulgaris
- Registration Number
- NCT05903716
- Lead Sponsor
- Marmara University
- Brief 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. 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 40
- Severe to moderate acne vulgaris
- 14 - 20 Years old
- Female patients
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Severe acne vulgaris Hormone 40 female patients aged 14-20 years, who were diagnosed with severe to moderate acne bulgaris and will be treated with isotretinoin. Healthy control Hormone 40 female patients aged 14-20 years Severe acne vulgaris Isotretinoin 40 female patients aged 14-20 years, who were diagnosed with severe to moderate acne bulgaris and will be treated with isotretinoin.
- Primary Outcome Measures
Name Time Method DHEA(LCMS) Level 3rd month of isotretinoin treatment Evaluation DHEA(LCMS) levels after 3 month of isotretinoin treatment
T4 Level 3rd month of isotretinoin treatment Evaluation T4 levels after 3 month of isotretinoin treatment
17-OH Progesteroone Level 3rd month of isotretinoin treatment Evaluation 17-OH Progesteroone after 3 month of isotretinoin treatment
DHEA-S(LCMS) Level 3rd month of isotretinoin treatment Evaluation DHEAS(LCMS) levels after 3 month of isotretinoin treatment
Testosterone(LCMS) Level 3rd month of isotretinoin treatment Evaluation Testosterone(LCMS) levels after 3 month of isotretinoin treatment
Estrogen Level 3rd month of isotretinoin treatment Evaluation Estrogen levels after 3 month of isotretinoin treatment
DHEA-s Level 3rd month of isotretinoin treatment Evaluation DHEA-s levels after 3 month of isotretinoin treatment
Androstenedione Level 3rd month of isotretinoin treatment Evaluation Androstenedione levels after 3 month of isotretinoin treatment
FSH Level 3rd month of isotretinoin treatment Evaluation FSH levels in after 3 month of isotretinoin treatment
Testosterone Level 3rd month of isotretinoin treatment Evaluation Testosterone levels after 3 month of isotretinoin treatment
LH Level 3rd month of isotretinoin treatment Evaluation LH levels after 3 month of isotretinoin treatment
Prolactin Level 3rd month of isotretinoin treatment Evaluation Prolactin levels after 3 month of isotretinoin treatment
TSH Level 3rd month of isotretinoin treatment Evaluation TSH levels iafter 3 month of isotretinoin treatment
Androsterone Level 3rd month of isotretinoin treatment Evaluation Androsterone levels after 3 month of isotretinoin treatment
21-Deoxycortisololone Level 3rd month of isotretinoin treatment Evaluation 21-Deoxycortisololone levels after 3 month of isotretinoin treatment
Free-Testosterone Level 3rd month of isotretinoin treatment Evaluation Free-Testosterone levels after 3 month of isotretinoin treatment
SHBG Level 3rd month of isotretinoin treatment Evaluation SHBG levels after 3 month of isotretinoin treatment
Corticosterone Level 3rd month of isotretinoin treatment Evaluation Corticosterone after 3 month of isotretinoin treatment
Aldosterone Level 3rd month of isotretinoin treatment Evaluation Aldosterone levels after 3 month of isotretinoin treatment
Dihydrotestosterone Level 3rd month of isotretinoin treatment Evaluation Dihydrotestosterone levels after 3 month of isotretinoin treatment
Cortisol Level 3rd month of isotretinoin treatment Evaluation Cortisol levels after 3 month of isotretinoin treatment
Estradiol Level 3rd month of isotretinoin treatment Evaluation Estradiol levels after 3 month of isotretinoin treatment
17-OH Pregnenolone Level 3rd month of isotretinoin treatment Evaluation 17-OH Pregnenolone levels after 3 month of isotretinoin treatment
11-Deoxycortisol Level 3rd month of isotretinoin treatment Evaluation 11-Deoxycortisol levels after 3 month of isotretinoin treatment
Progesterone(LCMS) Level 3rd month of isotretinoin treatment Evaluation Progesterone(LCMS) levels after 3 month of isotretinoin treatment
11-Deoxycortisolone Level 3rd month of isotretinoin treatment Evaluation 11-Deoxycortisolone levels after 3 month of isotretinoin treatment
Pregnenolone Level 3rd month of isotretinoin treatment Evaluation Pregnenolone levels after 3 month of isotretinoin treatment
- Secondary Outcome Measures
Name Time Method Relationship between Menstrual irregularity and hormone levels 3rd month of isotretinoin treatment Evaluation of the relationship between menstrual irregularity and changes in hormone levels
Comparison of hormone levels in acne vulgaris patients and healthy group Baseline Comparison of all hormone levels in acne vulgaris patients and healthy group
Menstrual İrregularity 2. 4. 6. months and 3 month after treatment Evaluation of side effects such as menstrual irregularity that can be seen due to isotretinoin
Trial Locations
- Locations (1)
Marmara University School of Medicine,Department of Dermatology.
🇹🇷Istanbul, Turkey