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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05903716
• Other study ID #: 09.2022.464
• Status: Recruiting
• Start date: September 15, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2023
• Source: Marmara University
• Contact: Baha Zaben, DR
• Phone: +905459112899
• Email: zabenbaha[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Diagnostic Test:
• Hormone
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

Drug:
• Isotretinoin
In 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

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine,Department of Dermatology.	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FSH Level	Evaluation FSH levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	FSH Level	Evaluation FSH levels in after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	LH Level	Evaluation LH levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	LH Level	Evaluation LH levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	Prolactin Level	Evaluation Prolactin levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	Prolactin Level	Evaluation Prolactin levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	Estrogen Level	Evaluation Estrogen levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	Estrogen Level	Evaluation Estrogen levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	Testosterone Level	Evaluation Testosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	Testosterone Level	Evaluation Testosterone levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	Free-Testosterone Level	Evaluation Free-Testosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	Free-Testosterone Level	Evaluation Free-Testosterone levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	DHEA-s Level	Evaluation DHEA-s levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	DHEA-s Level	Evaluation DHEA-s levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	SHBG Level	Evaluation SHBG levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	SHBG Level	Evaluation SHBG levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	TSH Level	Evaluation TSH levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	TSH Level	Evaluation TSH levels iafter 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	T4 Level	Evaluation T4 levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	T4 Level	Evaluation T4 levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	17-OH Progesteroone Level	Evaluation 17-OH Progesteroone levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	17-OH Progesteroone Level	Evaluation 17-OH Progesteroone after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	DHEA(LCMS) Level	Evaluation DHEA(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	DHEA(LCMS) Level	Evaluation DHEA(LCMS) levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	DHEA-S(LCMS) Level	Evaluation DHEAS(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatmen	Baseline (Before isotretinoin treatment)
Primary	DHEA-S(LCMS) Level	Evaluation DHEAS(LCMS) levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	Androstenedione Level	Evaluation Androstenedione levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	Androstenedione Level	Evaluation Androstenedione levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	Aldosterone Level	Evaluation Aldosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	Aldosterone Level	Evaluation Aldosterone levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	Testosterone(LCMS) Level	Evaluation Testosterone(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	Testosterone(LCMS) Level	Evaluation Testosterone(LCMS) levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	Dihydrotestosterone Level	Evaluation Dihydrotestosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	Dihydrotestosterone Level	Evaluation Dihydrotestosterone levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	Estradiol Level	Evaluation Estradiol levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	Estradiol Level	Evaluation Estradiol levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	17-OH Pregnenolone Level	Evaluation 17-OH Pregnenolone levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	17-OH Pregnenolone Level	Evaluation 17-OH Pregnenolone levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	Androsterone Level	Evaluation Androsterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	Androsterone Level	Evaluation Androsterone levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	Cortisol Level	Evaluation Cortisol levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	Cortisol Level	Evaluation Cortisol levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	Corticosterone Level	Evaluation Corticosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	Corticosterone Level	Evaluation Corticosterone after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	11-Deoxycortisol Level	Evaluation 11-Deoxycortisol levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	11-Deoxycortisol Level	Evaluation 11-Deoxycortisol levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	Progesterone(LCMS) Level	Evaluation Progesterone(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	Progesterone(LCMS) Level	Evaluation Progesterone(LCMS) levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	21-Deoxycortisololone Level	Evaluation 21-Deoxycortisololone levels in Severe Acne Vulgaris patient Before isotretinoin treatment	Baseline (Before isotretinoin treatment)
Primary	21-Deoxycortisololone Level	Evaluation 21-Deoxycortisololone levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	11-Deoxycortisolone Level	Evaluation 11-Deoxycortisolone levels in Severe Acne Vulgaris patient Before isotretinoin treatmen	Baseline (Before isotretinoin treatment)
Primary	11-Deoxycortisolone Level	Evaluation 11-Deoxycortisolone levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Primary	Pregnenolone Level	Evaluation Pregnenolone levels in Severe Acne Vulgaris patient Before isotretinoin treatmen	Baseline (Before isotretinoin treatment)
Primary	Pregnenolone Level	Evaluation Pregnenolone levels after 3 month of isotretinoin treatment	3rd month of isotretinoin treatment
Secondary	Comparison of hormone levels in acne vulgaris patients and healthy group	Comparison of all hormone levels in acne vulgaris patients and healthy group	Baseline
Secondary	Menstrual Irregularity	Evaluation of side effects such as menstrual irregularity that can be seen due to isotretinoin	2. 4. 6. months and 3 month after treatment
Secondary	Relationship between Menstrual irregularity and hormone levels	Evaluation of the relationship between menstrual irregularity and changes in hormone levels	3rd month of isotretinoin treatment