Clinical trial NCT05903716: The Effects of Systemic Isotretinoin Treatment on Adrenal Steroid and Sex Hormones Level in Severe Acne Vulgaris
Official title: The Effects of Systemic Isotretinoin Treatment on Adrenal Steroid and Sex Hormones Level in Severe Acne Vulgaris
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acne Vulgaris
Keywords: Isotretinoin
Adrenal steroid hormones
Sex hormones
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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


Eligibility criteria: Inclusion Criteria:

* Severe to moderate acne vulgaris
* 14 - 20 Years old
* Female patients

Exclusion Criteria:

* 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

Primary outcomes:
measure: FSH Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: FSH Level
timeFrame: 3rd month of isotretinoin treatment
measure: LH Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: LH Level
timeFrame: 3rd month of isotretinoin treatment
measure: Prolactin Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: Prolactin Level
timeFrame: 3rd month of isotretinoin treatment
measure: Estrogen Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: Estrogen Level
timeFrame: 3rd month of isotretinoin treatment
measure: Testosterone Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: Testosterone Level
timeFrame: 3rd month of isotretinoin treatment
measure: Free-Testosterone Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: Free-Testosterone Level
timeFrame: 3rd month of isotretinoin treatment
measure: DHEA-s Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: DHEA-s Level
timeFrame: 3rd month of isotretinoin treatment
measure: SHBG Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: SHBG Level
timeFrame: 3rd month of isotretinoin treatment
measure: TSH Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: TSH Level
timeFrame: 3rd month of isotretinoin treatment
measure: T4 Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: T4 Level
timeFrame: 3rd month of isotretinoin treatment
measure: 17-OH Progesteroone Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: 17-OH Progesteroone Level
timeFrame: 3rd month of isotretinoin treatment
measure: DHEA(LCMS) Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: DHEA(LCMS) Level
timeFrame: 3rd month of isotretinoin treatment
measure: DHEA-S(LCMS) Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: DHEA-S(LCMS) Level
timeFrame: 3rd month of isotretinoin treatment
measure: Androstenedione Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: Androstenedione Level
timeFrame: 3rd month of isotretinoin treatment
measure: Aldosterone Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: Aldosterone Level
timeFrame: 3rd month of isotretinoin treatment
measure: Testosterone(LCMS) Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: Testosterone(LCMS) Level
timeFrame: 3rd month of isotretinoin treatment
measure: Dihydrotestosterone Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: Dihydrotestosterone Level
timeFrame: 3rd month of isotretinoin treatment
measure: Estradiol Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: Estradiol Level
timeFrame: 3rd month of isotretinoin treatment
measure: 17-OH Pregnenolone Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: 17-OH Pregnenolone Level
timeFrame: 3rd month of isotretinoin treatment
measure: Androsterone Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: Androsterone Level
timeFrame: 3rd month of isotretinoin treatment
measure: Cortisol Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: Cortisol Level
timeFrame: 3rd month of isotretinoin treatment
measure: Corticosterone Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: Corticosterone Level
timeFrame: 3rd month of isotretinoin treatment
measure: 11-Deoxycortisol Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: 11-Deoxycortisol Level
timeFrame: 3rd month of isotretinoin treatment
measure: Progesterone(LCMS) Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: Progesterone(LCMS) Level
timeFrame: 3rd month of isotretinoin treatment
measure: 21-Deoxycortisololone Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: 21-Deoxycortisololone Level
timeFrame: 3rd month of isotretinoin treatment
measure: 11-Deoxycortisolone Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: 11-Deoxycortisolone Level
timeFrame: 3rd month of isotretinoin treatment
measure: Pregnenolone Level
timeFrame: Baseline (Before isotretinoin treatment)
measure: Pregnenolone Level
timeFrame: 3rd month of isotretinoin treatment
Secondary outcomes:
measure: Comparison of hormone levels in acne vulgaris patients and healthy group
timeFrame: Baseline
measure: Menstrual İrregularity
timeFrame: 2. 4. 6. months and 3 month after treatment
measure: Relationship between Menstrual irregularity and hormone levels
timeFrame: 3rd month of isotretinoin treatment
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine,Department of Dermatology.
Study officials:
References: