The Effects of Systemic Isotretinoin Treatment on Adrenal Steroid and Sex Hormones Level in Severe Acne Vulgaris

NCT05903716 — Unknown, 40 participants, Marmara University
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RegistryNCT05903716
StatusUnknown
Study typeObservational
Enrollment40 (Estimated)
SponsorMarmara University (Other)
ConditionsAcne Vulgaris
InterventionsHormone, Isotretinoin (Diagnostic test, drug)
Datesstart 2022-09-15, primary completion 2023-06-30 (estimated), completion 2023-06-30 (estimated), first posted 2023-06-15, last updated 2023-06-15
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Acne Vulgaris All trials of Hormone All trials of Isotretinoin

-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

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+Arms and interventions

ArmTypeInterventionsDescription
Severe acne vulgarisDiagnostic 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 controlDiagnostic Test: Hormone40 female patients aged 14-20 years
  • Hormone (Diagnostic 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
  • Isotretinoin (Drug): 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

+Outcome measures

Primary outcomes

  • FSH Level [Baseline (Before isotretinoin treatment)]: Evaluation FSH levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • FSH Level [3rd month of isotretinoin treatment]: Evaluation FSH levels in after 3 month of isotretinoin treatment
  • LH Level [Baseline (Before isotretinoin treatment)]: Evaluation LH levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • LH Level [3rd month of isotretinoin treatment]: Evaluation LH levels after 3 month of isotretinoin treatment
  • Prolactin Level [Baseline (Before isotretinoin treatment)]: Evaluation Prolactin levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • Prolactin Level [3rd month of isotretinoin treatment]: Evaluation Prolactin levels after 3 month of isotretinoin treatment
  • Estrogen Level [Baseline (Before isotretinoin treatment)]: Evaluation Estrogen levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • Estrogen Level [3rd month of isotretinoin treatment]: Evaluation Estrogen levels after 3 month of isotretinoin treatment
  • Testosterone Level [Baseline (Before isotretinoin treatment)]: Evaluation Testosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • Testosterone Level [3rd month of isotretinoin treatment]: Evaluation Testosterone levels after 3 month of isotretinoin treatment
  • Free-Testosterone Level [Baseline (Before isotretinoin treatment)]: Evaluation Free-Testosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • Free-Testosterone Level [3rd month of isotretinoin treatment]: Evaluation Free-Testosterone levels after 3 month of isotretinoin treatment
  • DHEA-s Level [Baseline (Before isotretinoin treatment)]: Evaluation DHEA-s levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • DHEA-s Level [3rd month of isotretinoin treatment]: Evaluation DHEA-s levels after 3 month of isotretinoin treatment
  • SHBG Level [Baseline (Before isotretinoin treatment)]: Evaluation SHBG levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • SHBG Level [3rd month of isotretinoin treatment]: Evaluation SHBG levels after 3 month of isotretinoin treatment
  • TSH Level [Baseline (Before isotretinoin treatment)]: Evaluation TSH levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • TSH Level [3rd month of isotretinoin treatment]: Evaluation TSH levels iafter 3 month of isotretinoin treatment
  • T4 Level [Baseline (Before isotretinoin treatment)]: Evaluation T4 levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • T4 Level [3rd month of isotretinoin treatment]: Evaluation T4 levels after 3 month of isotretinoin treatment
  • 17-OH Progesteroone Level [Baseline (Before isotretinoin treatment)]: Evaluation 17-OH Progesteroone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • 17-OH Progesteroone Level [3rd month of isotretinoin treatment]: Evaluation 17-OH Progesteroone after 3 month of isotretinoin treatment
  • DHEA(LCMS) Level [Baseline (Before isotretinoin treatment)]: Evaluation DHEA(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • DHEA(LCMS) Level [3rd month of isotretinoin treatment]: Evaluation DHEA(LCMS) levels after 3 month of isotretinoin treatment
  • DHEA-S(LCMS) Level [Baseline (Before isotretinoin treatment)]: Evaluation DHEAS(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatmen
  • DHEA-S(LCMS) Level [3rd month of isotretinoin treatment]: Evaluation DHEAS(LCMS) levels after 3 month of isotretinoin treatment
  • Androstenedione Level [Baseline (Before isotretinoin treatment)]: Evaluation Androstenedione levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • Androstenedione Level [3rd month of isotretinoin treatment]: Evaluation Androstenedione levels after 3 month of isotretinoin treatment
  • Aldosterone Level [Baseline (Before isotretinoin treatment)]: Evaluation Aldosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • Aldosterone Level [3rd month of isotretinoin treatment]: Evaluation Aldosterone levels after 3 month of isotretinoin treatment
  • Testosterone(LCMS) Level [Baseline (Before isotretinoin treatment)]: Evaluation Testosterone(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • Testosterone(LCMS) Level [3rd month of isotretinoin treatment]: Evaluation Testosterone(LCMS) levels after 3 month of isotretinoin treatment
  • Dihydrotestosterone Level [Baseline (Before isotretinoin treatment)]: Evaluation Dihydrotestosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • Dihydrotestosterone Level [3rd month of isotretinoin treatment]: Evaluation Dihydrotestosterone levels after 3 month of isotretinoin treatment
  • Estradiol Level [Baseline (Before isotretinoin treatment)]: Evaluation Estradiol levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • Estradiol Level [3rd month of isotretinoin treatment]: Evaluation Estradiol levels after 3 month of isotretinoin treatment
  • 17-OH Pregnenolone Level [Baseline (Before isotretinoin treatment)]: Evaluation 17-OH Pregnenolone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • 17-OH Pregnenolone Level [3rd month of isotretinoin treatment]: Evaluation 17-OH Pregnenolone levels after 3 month of isotretinoin treatment
  • Androsterone Level [Baseline (Before isotretinoin treatment)]: Evaluation Androsterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • Androsterone Level [3rd month of isotretinoin treatment]: Evaluation Androsterone levels after 3 month of isotretinoin treatment
  • Cortisol Level [Baseline (Before isotretinoin treatment)]: Evaluation Cortisol levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • Cortisol Level [3rd month of isotretinoin treatment]: Evaluation Cortisol levels after 3 month of isotretinoin treatment
  • Corticosterone Level [Baseline (Before isotretinoin treatment)]: Evaluation Corticosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • Corticosterone Level [3rd month of isotretinoin treatment]: Evaluation Corticosterone after 3 month of isotretinoin treatment
  • 11-Deoxycortisol Level [Baseline (Before isotretinoin treatment)]: Evaluation 11-Deoxycortisol levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • 11-Deoxycortisol Level [3rd month of isotretinoin treatment]: Evaluation 11-Deoxycortisol levels after 3 month of isotretinoin treatment
  • Progesterone(LCMS) Level [Baseline (Before isotretinoin treatment)]: Evaluation Progesterone(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • Progesterone(LCMS) Level [3rd month of isotretinoin treatment]: Evaluation Progesterone(LCMS) levels after 3 month of isotretinoin treatment
  • 21-Deoxycortisololone Level [Baseline (Before isotretinoin treatment)]: Evaluation 21-Deoxycortisololone levels in Severe Acne Vulgaris patient Before isotretinoin treatment
  • 21-Deoxycortisololone Level [3rd month of isotretinoin treatment]: Evaluation 21-Deoxycortisololone levels after 3 month of isotretinoin treatment
  • 11-Deoxycortisolone Level [Baseline (Before isotretinoin treatment)]: Evaluation 11-Deoxycortisolone levels in Severe Acne Vulgaris patient Before isotretinoin treatmen
  • 11-Deoxycortisolone Level [3rd month of isotretinoin treatment]: Evaluation 11-Deoxycortisolone levels after 3 month of isotretinoin treatment
  • Pregnenolone Level [Baseline (Before isotretinoin treatment)]: Evaluation Pregnenolone levels in Severe Acne Vulgaris patient Before isotretinoin treatmen
  • Pregnenolone Level [3rd month of isotretinoin treatment]: Evaluation Pregnenolone levels after 3 month of isotretinoin treatment

Secondary outcomes

  • 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
  • Relationship between Menstrual irregularity and hormone levels [3rd month of isotretinoin treatment]: Evaluation of the relationship between menstrual irregularity and changes in hormone levels

+Eligibility

Sex: Female, ages: 14 Years to 20 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Marmara University School of Medicine,Department of Dermatology.IstanbulTurkey (Türkiye)Recruiting