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

Recruiting

• Conditions: Acne Vulgaris
• Interventions: Diagnostic Test: Hormone; Drug: Isotretinoin

• 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.
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Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-09-15
• Study First Submitted: 2023-03-26
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-11
• Last Update Submitted: 2023-06-11
• Study First Posted: 2023-06-15
• Last Update Posted: 2023-06-15
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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

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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

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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