|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
25 May 2015 |
|
Main ID: |
NCT02438020 |
|
Date of registration:
|
03/05/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Study of Efficacy of Metformin in the Treatment of Acanthosis Nigricans in Children With Obesity
|
|
Scientific title:
|
Double-blind Randomized Trial Using Oral Metformin Versus Placebo in the Treatment of Acanthosis Nigricans in Children With Obesity |
|
Date of first enrolment:
|
June 2015 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Not yet recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT02438020 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Mexico
| | | | | | | |
|
Contacts
|
|
Name:
|
Juan P Castanedo-Cazares, MD |
|
Address:
|
|
|
Telephone:
|
524448342795 |
|
Email:
|
castanju@yahoo.com |
|
Affiliation:
|
|
|
|
Name:
|
Francisco Goldaracena-Orozco, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hospital Central "Dr. Ignacio Morones Prieto" |
|
|
Name:
|
Bertha Torres-Alvarez, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hospital Central "Dr. Ignacio Morones Prieto" |
|
|
Name:
|
Juan P Castanedo-Cazares, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hospital Central "Dr. Ignacio Morones Prieto" |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Signed informed consent from children and parents.
- Children younger than 18 years.
- Clinical diagnosis of acanthosis nigricans.
- Obesity.
Exclusion Criteria:
- Diabetes mellitus.
- Neurological diseases.
- Congenital diseases.
- Oral treatment for obesity in the last two months.
- Topical treatment for the last two months.
Age minimum:
8 Years
Age maximum:
17 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Acanthosis Nigricans
|
|
Intervention(s)
|
|
Other: Placebo
|
|
Drug: Metformin
|
|
Primary Outcome(s)
|
|
Clinical improvement of acanthosis nigricans
[Time Frame: baseline and 12 weeks]
|
|
Secondary Outcome(s)
|
|
Depigmentation of acanthosis nigricans
[Time Frame: baseline and 12 weeks]
|
|
Histological improvement of acanthosis nigricans
[Time Frame: baseline and 12 weeks]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|