Acanthosis NigricansPhase 4NCT02438020
Study of Efficacy of Metformin in the Treatment of Acanthosis Nigricans in Children With Obesity
A Phase 4 study testing Metformin in people with Acanthosis Nigricans, run by Juan Pablo Castanedo-Cazares at 1 site in Mexico.
Trial summary
Obesity is often accompanied by insulin resistance and/or hyperinsulinemia. Acanthosis nigricans (AN) is a skin condition commonly present on the neck of obese children. Metformin is a useful drug for conditions characterized by insulin resistance.The aim of this study is to compare the efficacy of metformin versus… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Acanthosis Nigricans
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2015to Oct 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed informed consent from children and parents.
- Children younger than 18 years.
- Clinical diagnosis of acanthosis nigricans.
- Obesity.
Who cannot join
- Diabetes mellitus.
- Neurological diseases.
- Congenital diseases.
- Oral treatment for obesity in the last two months.
- Topical treatment for the last two months.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Central Dr.Ignacio Morones Prieto
San Luis Potosí City, San Luis Potosí, 78210
About this study
Official title: Double-blind Randomized Trial Using Oral Metformin Versus Placebo in the Treatment of Acanthosis Nigricans in Children With Obesity
Obesity is often accompanied by insulin resistance and/or hyperinsulinemia. Acanthosis nigricans (AN) is a skin condition commonly present on the neck of obese children. Metformin is a useful drug for conditions characterized by insulin resistance.The aim of this study is to compare the efficacy of metformin versus placebo on AN lesions of the neck as well as their effects on metabolic and anthropometric variables in a sample of obese children. This is a 12-week randomized, double-blind randomized trial involving obese children with AN to receive either metformin or placebo.
Evaluations will be performed every three weeks. Clinical, histological and colorimetric assessments of AN lesions will be compared initially and at the conclusion of the study.
Read the detailed description
Acanthosis nigricans (AN) are lesions affecting localized areas of the skin in persons with obesity and/or hyperinsulinemia. Roughening of the skin is related with histological papillomatosis and the skin darkening is due to hyperkeratosis. Biochemical mechanisms for developing this hyperplastic lesion involve local cutaneous growth factors. Nearly 40% of Native American teenagers have acanthosis nigricans, whereas about 13% of African American, 6% of Hispanic, and less than 1% of white, non-Hispanic children aged 10-19 have clinically apparent acanthosis nigricans. AN is a clinical surrogate of laboratory-documented hyperinsulinemia.
The aim of this study is to compare the efficacy of metformin versus placebo on AN lesions of the neck as well as their effects on metabolic (HOMA, triglycerides, cholesterol) and anthropometric variables (BMI, waist) in a sample of obese children. This is a 12-week randomized, double-blind randomized trial involving obese children with AN to receive either metformin or placebo.
Evaluations will be performed every three weeks. Clinical, histological and colorimetric assessments of AN lesions will be compared initially and at the conclusion of the study. Burke´s scale, papillomatosis and hyperkeratosis, and the L* axis of will be used to measure the AN improvement.
- Conditions
- Acanthosis Nigricans
- Being tested
- Metformin, Placebo
- Keywords
- Acanthosis nigricans, obesity, children, metformin
- Medical subject headings
- Acanthosis Nigricans, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage, Glumetza, Fortamet, Riomet
One tablet of 500 mg will be ingested before the main meal
PlaceboOther
A placebo tablet will be ingested daily before main meal.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | 500 mg metformin oral intake before main meal Receives: Drug: Metformin |
| Placebo | Placebo comparator | Placebo tablet before main meal. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement of acanthosis nigricans
Initial and after intervention assessment of acanthosis nigricans using the quantitative scale of Burke (Diabetes Care 22:1655-1659, 1999).
Five anatomical sites were chosen to assess the presence and extent of AN: neck, axilla, knuckles, elbows, and knees. The neck and axilla are graded for severity on a scale from 0 to 4. For AN present on the neck, texture of the affected area is also measured on a scale from 0 to 3. Knuckles, elbows, and knees are graded as AN present (1) or absent (0). Score goes from 0 to 14.
Measured: baseline and 12 weeks
Secondary outcomes (2)
Histological improvement of acanthosis nigricans
Epidermal and stratum corneum thickness of 3 mm skin samples obtained from neck will be measured using an image processing software initially and at the end of trial.
Measured: baseline and 12 weeks
Depigmentation of acanthosis nigricans
Quantification of pigmentation change of lesions by means of the L axis of the CIE system. 0 is pure white, 100 y total dark. Initially, and at the end of study.
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acanthosis NigricansStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan Pablo Castanedo-Cazares
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Central "Dr. Ignacio Morones Prieto"
- Responsible party
- Sponsor-investigator, Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí
- Investigators
- Bertha Torres-Alvarez, MD, Study chair, Hospital Central "Dr. Ignacio Morones Prieto"Juan P Castanedo-Cazares, MD, Study director, Hospital Central "Dr. Ignacio Morones Prieto"Francisco Goldaracena-Orozco, MD, Principal investigator, Hospital Central "Dr. Ignacio Morones Prieto"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438020
- Sponsor's protocol ID
- MET-AN
- Status last verified
- May 2015
- First submitted
- 3 May 2015
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bellot-Rojas P, Posadas-Sanchez R, Caracas-Portilla N, Zamora-Gonzalez J, Cardoso-Saldana G, Jurado-Santacruz F, Posadas-Romero C. Comparison of metformin versus rosiglitazone in patients with Acanthosis nigricans: a pilot study. J Drugs Dermatol. 2006 Oct;5(9):884-9.
PubMed 17039655Freemark M, Bursey D. The effects of metformin on body mass index and glucose tolerance in obese adolescents with fasting hyperinsulinemia and a family history of type 2 diabetes. Pediatrics. 2001 Apr;107(4):E55. doi: 10.1542/peds.107.4.e55.
PubMed 11335776Romo A, Benavides S. Treatment options in insulin resistance obesity-related acanthosis nigricans. Ann Pharmacother. 2008 Jul;42(7):1090-4. doi: 10.1345/aph.1K446. Epub 2008 May 20.
PubMed 18492785
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Trial Using Oral Metformin Versus Placebo in the Treatment of Acanthosis Nigricans in Children With Obesity
- ClinicalTrials.gov ID
- NCT02438020
- Acronym / sponsor ID
- MET-AN
- Conditions
- Acanthosis Nigricans
- Keywords
- Acanthosis nigricans, obesity, children, metformin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Juan Pablo Castanedo-CazaresUniversity, hospital or other
- Collaborators
- Hospital Central "Dr. Ignacio Morones Prieto"
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is often accompanied by insulin resistance and/or hyperinsulinemia. Acanthosis nigricans (AN) is a skin condition commonly present on the neck of obese children. Metformin is a useful drug for conditions characterized by insulin resistance.The aim of this study is to compare the efficacy of metformin versus placebo on AN lesions of the neck as well as their effects on metabolic and anthropometric variables in a sample of obese children. This is a 12-week randomized, double-blind randomized trial involving obese children with AN to receive either metformin or placebo.
Evaluations will be performed every three weeks. Clinical, histological and colorimetric assessments of AN lesions will be compared initially and at the conclusion of the study.
Detailed description
Acanthosis nigricans (AN) are lesions affecting localized areas of the skin in persons with obesity and/or hyperinsulinemia. Roughening of the skin is related with histological papillomatosis and the skin darkening is due to hyperkeratosis. Biochemical mechanisms for developing this hyperplastic lesion involve local cutaneous growth factors. Nearly 40% of Native American teenagers have acanthosis nigricans, whereas about 13% of African American, 6% of Hispanic, and less than 1% of white, non-Hispanic children aged 10-19 have clinically apparent acanthosis nigricans. AN is a clinical surrogate of laboratory-documented hyperinsulinemia.
The aim of this study is to compare the efficacy of metformin versus placebo on AN lesions of the neck as well as their effects on metabolic (HOMA, triglycerides, cholesterol) and anthropometric variables (BMI, waist) in a sample of obese children. This is a 12-week randomized, double-blind randomized trial involving obese children with AN to receive either metformin or placebo.
Evaluations will be performed every three weeks. Clinical, histological and colorimetric assessments of AN lesions will be compared initially and at the conclusion of the study. Burke´s scale, papillomatosis and hyperkeratosis, and the L* axis of will be used to measure the AN improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Metformin500 mg metformin oral intake before main meal |
| Placebo | Placebo comparator | Other: PlaceboPlacebo tablet before main meal. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Signed informed consent from children and parents.
- Children younger than 18 years.
- Clinical diagnosis of acanthosis nigricans.
- Obesity.
Key exclusion criteria (5 listed)
- Diabetes mellitus.
- Neurological diseases.
- Congenital diseases.
- Oral treatment for obesity in the last two months.
- Topical treatment for the last two months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: Glucophage, Glumetza, Fortamet, RiometOne tablet of 500 mg will be ingested before the main meal | Drug | Metformin |
| PlaceboA placebo tablet will be ingested daily before main meal. | Other | Placebo |
Primary outcome
Clinical improvement of acanthosis nigricans
Time frame: baseline and 12 weeks
Initial and after intervention assessment of acanthosis nigricans using the quantitative scale of Burke (Diabetes Care 22:1655-1659, 1999). Five anatomical sites were chosen to assess the presence and extent of AN: neck, axilla, knuckles, elbows, and knees. The neck and axilla are graded for severity on a scale from 0 to 4. For AN present on the neck, texture of the affected area is also measured on a scale from 0 to 3. Knuckles, elbows, and knees are graded as AN present (1) or absent (0). Score goes from 0 to 14.
2 secondary outcomes
Histological improvement of acanthosis nigricans
Time frame: baseline and 12 weeks
Depigmentation of acanthosis nigricans
Time frame: baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
- Background: PubMed 17039655Bellot-Rojas P, Posadas-Sanchez R, Caracas-Portilla N, Zamora-Gonzalez J, Cardoso-Saldana G, Jurado-Santacruz F, Posadas-Romero C. Comparison of metformin versus rosiglitazone in patients with Acanthosis nigricans: a pilot study. J Drugs Dermatol. 2006 Oct;5(9):884-9.
- Background: PubMed 11335776Freemark M, Bursey D. The effects of metformin on body mass index and glucose tolerance in obese adolescents with fasting hyperinsulinemia and a family history of type 2 diabetes. Pediatrics. 2001 Apr;107(4):E55. doi: 10.1542/peds.107.4.e55.
- Background: PubMed 18492785Romo A, Benavides S. Treatment options in insulin resistance obesity-related acanthosis nigricans. Ann Pharmacother. 2008 Jul;42(7):1090-4. doi: 10.1345/aph.1K446. Epub 2008 May 20.
Related trials for Acanthosis Nigricans
Not yet recruitingPhase 1
Efficacy and Safety Of Fractional Carbon Dioxide Laser Plus Topical Metformin In Treatment Of Acanthosis Nigricans
Acanthosis Nigricans
Active, not recruitingPhase 2
Effect of Metreleptin Therapy in the Treatment of Severe Insulin Resistance
Severe Insulin Resistance
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertha Torres-Alvarez, MD study chair
Hospital Central "Dr. Ignacio Morones Prieto"
Juan P Castanedo-Cazares, MD study director
Hospital Central "Dr. Ignacio Morones Prieto"
Francisco Goldaracena-Orozco, MD principal investigator
Hospital Central "Dr. Ignacio Morones Prieto"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin in people with Acanthosis Nigricans, run by Juan Pablo Castanedo-Cazares at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan P Castanedo-Cazares, MD (524448342795, castanju@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement of acanthosis nigricans (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02438020, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015.