Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05903716
Status:
RECRUITING
Last Update Posted:
2023-06-15
First Post:
2023-03-26
Brief Title:
The Effects of Systemic Isotretinoin Treatment on Adrenal Steroid and Sex Hormones Level in Severe Acne Vulgaris
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
The Effects of Systemic Isotretinoin Treatment on Adrenal Steroid and Sex Hormones Level in Severe Acne Vulgaris
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05-08mgkgday The total cumulative dose is 120 mgkg
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 LCMSMS 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
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 05-08mgkgday The total cumulative dose is 120 mgkg
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 LCMSMS 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None