NCT05903716

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

10 months

First QC Date

March 26, 2023

Last Update Submit

June 11, 2023

Conditions

Acne Vulgaris

Keywords

IsotretinoinAdrenal steroid hormonesSex hormones

Outcome Measures

Primary Outcomes (54)

  • FSH Level

    Evaluation FSH levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • FSH Level

    Evaluation FSH levels in after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • LH Level

    Evaluation LH levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • LH Level

    Evaluation LH levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • Prolactin Level

    Evaluation Prolactin levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • Prolactin Level

    Evaluation Prolactin levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • Estrogen Level

    Evaluation Estrogen levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • Estrogen Level

    Evaluation Estrogen levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • Testosterone Level

    Evaluation Testosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • Testosterone Level

    Evaluation Testosterone levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • Free-Testosterone Level

    Evaluation Free-Testosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • Free-Testosterone Level

    Evaluation Free-Testosterone levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • DHEA-s Level

    Evaluation DHEA-s levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • DHEA-s Level

    Evaluation DHEA-s levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • SHBG Level

    Evaluation SHBG levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • SHBG Level

    Evaluation SHBG levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • TSH Level

    Evaluation TSH levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • TSH Level

    Evaluation TSH levels iafter 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • T4 Level

    Evaluation T4 levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • T4 Level

    Evaluation T4 levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • 17-OH Progesteroone Level

    Evaluation 17-OH Progesteroone levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • 17-OH Progesteroone Level

    Evaluation 17-OH Progesteroone after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • DHEA(LCMS) Level

    Evaluation DHEA(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • DHEA(LCMS) Level

    Evaluation DHEA(LCMS) levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • DHEA-S(LCMS) Level

    Evaluation DHEAS(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatmen

    Baseline (Before isotretinoin treatment)

  • DHEA-S(LCMS) Level

    Evaluation DHEAS(LCMS) levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • Androstenedione Level

    Evaluation Androstenedione levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • Androstenedione Level

    Evaluation Androstenedione levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • Aldosterone Level

    Evaluation Aldosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • Aldosterone Level

    Evaluation Aldosterone levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • Testosterone(LCMS) Level

    Evaluation Testosterone(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • Testosterone(LCMS) Level

    Evaluation Testosterone(LCMS) levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • Dihydrotestosterone Level

    Evaluation Dihydrotestosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • Dihydrotestosterone Level

    Evaluation Dihydrotestosterone levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • Estradiol Level

    Evaluation Estradiol levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • Estradiol Level

    Evaluation Estradiol levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • 17-OH Pregnenolone Level

    Evaluation 17-OH Pregnenolone levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • 17-OH Pregnenolone Level

    Evaluation 17-OH Pregnenolone levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • Androsterone Level

    Evaluation Androsterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • Androsterone Level

    Evaluation Androsterone levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • Cortisol Level

    Evaluation Cortisol levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • Cortisol Level

    Evaluation Cortisol levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • Corticosterone Level

    Evaluation Corticosterone levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • Corticosterone Level

    Evaluation Corticosterone after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • 11-Deoxycortisol Level

    Evaluation 11-Deoxycortisol levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • 11-Deoxycortisol Level

    Evaluation 11-Deoxycortisol levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • Progesterone(LCMS) Level

    Evaluation Progesterone(LCMS) levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • Progesterone(LCMS) Level

    Evaluation Progesterone(LCMS) levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • 21-Deoxycortisololone Level

    Evaluation 21-Deoxycortisololone levels in Severe Acne Vulgaris patient Before isotretinoin treatment

    Baseline (Before isotretinoin treatment)

  • 21-Deoxycortisololone Level

    Evaluation 21-Deoxycortisololone levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • 11-Deoxycortisolone Level

    Evaluation 11-Deoxycortisolone levels in Severe Acne Vulgaris patient Before isotretinoin treatmen

    Baseline (Before isotretinoin treatment)

  • 11-Deoxycortisolone Level

    Evaluation 11-Deoxycortisolone levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

  • Pregnenolone Level

    Evaluation Pregnenolone levels in Severe Acne Vulgaris patient Before isotretinoin treatmen

    Baseline (Before isotretinoin treatment)

  • Pregnenolone Level

    Evaluation Pregnenolone levels after 3 month of isotretinoin treatment

    3rd month of isotretinoin treatment

Secondary Outcomes (3)

  • Comparison of hormone levels in acne vulgaris patients and healthy group

    Baseline

  • Menstrual Ä°rregularity

    2. 4. 6. months and 3 month after treatment

  • Relationship between Menstrual irregularity and hormone levels

    3rd month of isotretinoin treatment

Study Arms (2)

Severe acne vulgaris

40 female patients aged 14-20 years, who were diagnosed with severe to moderate acne bulgaris and will be treated with isotretinoin.

Diagnostic Test: HormoneDrug: Isotretinoin

Healthy control

40 female patients aged 14-20 years

Diagnostic Test: Hormone

Interventions

HormoneDIAGNOSTIC_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

Healthy controlSevere acne vulgaris
IsotretinoinDRUG

Ä°n 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

Severe acne vulgaris

Eligibility Criteria

Age14 Years - 20 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Severe to moderate acne vulgaris
  • Years old
  • Female patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine,Department of Dermatology.

Istanbul, Turkey (TĂĽrkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

To investigate the17-OH Progesteroone, DHEA, DHEAS, Androstenedione, Aldosterone, Testosterone, Dihydrotestosterone, Estradiol, 17-OH Pregnenolone, Androsterone, Cortisol, Corticosterone, 11-Deoxycortisol, Progesterone, 21-Deoxycortisololone, 11-Deoxycortisolone, Pregnenolone hormones with LCMS/MS technique a 5 ml blood sample was collected from patients. To investigate FSH, LH, Prolactin, Estrogen, Testosterone, free testosterone, DHEA-s, SHBG, TSH, T4 hormone levels will be evaluated by ELISA method a 5 ml blood sample was collected from patients. .

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Thyroid Function TestsIsotretinoin

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, EndocrineDiagnostic Techniques and ProceduresDiagnosisRetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Central Study Contacts

Baha Zaben, DR

CONTACT

+905459112899zabenbaha@gmail.com

Ayse Deniz Yucelten, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2023

First Posted

June 15, 2023

Study Start

September 15, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

TU(1)