UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054398 |
|---|---|
| Receipt number | R000062136 |
| Scientific Title | Effect of oral isotritinion on sexual function and desire in males with acne vulgaris: a cross sectional randomized study |
| Date of disclosure of the study information | 2024/05/16 |
| Last modified on | 2024/05/14 22:10:33 |
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Basic information
Public title
Effect of oral isotritinion on sexual function and desire in males with acne vulgaris: a cross sectional randomized study
Acronym
Effect of oral isotritinion on sexual function and desire in males with acne vulgaris: a cross sectional randomized study
Scientific Title
Effect of oral isotritinion on sexual function and desire in males with acne vulgaris: a cross sectional randomized study
Scientific Title:Acronym
Effect of oral isotritinion on sexual function and desire in males with acne vulgaris: a cross sectional randomized study
Region
| Africa |
Condition
Condition
Acne vulgaris and male sexual dysfunction
Classification by specialty
| Dermatology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the presence of sexual dysfunction in male patients receiving isotretinion for treatment of acne vulgaris.
Assessment of the severity of acne.
Basic objectives2
Others
Basic objectives -Others
To evaluate relationship of male sexual dysfunction & symptoms of anxiety and depression in males caused by acne vulgaris and isotretinion treatment.
To evaluate the effect of isotretinion on male sexual desire
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To identify the presence of sexual dysfunction in male patients receiving isotretinion for treatment of acne vulgaris.
Assessment of the severity of acne.
Key secondary outcomes
To evaluate relationship of male sexual dysfunction & symptoms of anxiety and depression in males caused by acne vulgaris and isotretinion treatment.
To evaluate the effect of isotretinion on male sexual desire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group 1: normal males not receiving isotretinion (control group)
Interventions/Control_2
Group 2: male patient receiving isotretinion for 2 months.
Interventions/Control_3
Group 3: male patient receiving isotretinion for 4 months
Interventions/Control_4
Group 4: male patient receiving isotretinion for 6 months
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
Males with severe nodulocystic acne
Key exclusion criteria
Any male with systemic illnesses or receiving medication causing erectile dysfunction or affecting his desire
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Sameh |
| Middle name | Fayek |
| Last name | GamalEl Din |
Organization
Kasr Alainy faculty of medicine
Division name
Andrology & STDs
Zip code
002
Address
South academy, New cairo, Cairo
TEL
002025729584
samehfayek@kasralainy.edu.eg
Public contact
Name of contact person
| 1st name | Sameh |
| Middle name | Fayek |
| Last name | GamalEl Din |
Organization
Cairo University
Division name
Andrology & STDs
Zip code
002
Address
South academy, New cairo, Cairo
TEL
002025729584
Homepage URL
http://scholar.cu.edu.eg/sfayek
samehfayek@kasralainy.edu.eg
Sponsor or person
Institute
Cairo university
Institute
Department
Personal name
sameh fayek gamalEl Din
Funding Source
Organization
Cairo university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Beni Suef university
Address
Elsaray street elmanial
Tel
0020 25 729 584
samehfayek@kasralainy.edu.eg
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 17 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 17 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 14 | Day |
Last modified on
| 2024 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062136
