Study of the Effect of Fractional co2 Laser Versus Q Switched:NdYAG Laser in the Treatment of Acanthosis Nigricans
Primary Purpose
Acanthosis Nigricans
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
co2 laser
Sponsored by
About this trial
This is an interventional treatment trial for Acanthosis Nigricans
Eligibility Criteria
Inclusion Criteria:
- age more than 18 years old
- both genders
- skin type III to V
- controlled diabetus
Exclusion Criteria:
- pregnancy and lactation
- scarring
- active skin infections
- endocrinal disorders
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1 group of 20 patients doing both types of lasers on 2 sites
Arm Description
comparing both types of laser
Outcomes
Primary Outcome Measures
patient evaluation
Acanthosis nigricans area and severity index is scoring system used to assess patients before the session and after the session to assess finally the improvement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04893304
Brief Title
Study of the Effect of Fractional co2 Laser Versus Q Switched:NdYAG Laser in the Treatment of Acanthosis Nigricans
Official Title
Study of the Effect of Fractional co2 Laser Versus Q Switched:NdYAG Laser in the Treatment of Acanthosis Nigricans
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 30, 2021 (Anticipated)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This prospective randomized comparative split study will be conducted at the outpatient clinic, Dermatology department, Faculty of Medicine, Cairo University and will include 20 patients with acanthosis nigricans in otherwise healthy individuals which will be recruited and assessed for eligibility for inclusion according to the above criteria.
-Evaluation:
All patients will be subjected to:
Pre-operative preparation:
Informed written consent will be taken from every patient prior to the study.
Detailed history taking including onset, course, duration of the disease and occupation (sun-exposed or not), predisposing factors, history of keloid tendency, associated diseases and previous treatments.
Assessment of skin type, BMI, degree of AN, HbA1C, site of lesions in all patients and degree of improvement.
Photography: will evaluate the clinical response to treatment for each patient Photos will be taken before starting the study, before every session, and two weeks after the last session.
Melanin index (MI) will be measured using reflectance spectrophotometer in order to assess the degree of hyperpigmentation before starting the study and two weeks after the last session. Research Template 8 Final Version: April 2019
Acanthosis Nigricans Area and Severity Index (ANASI) score (Zaki et al., 2018) will be done for all patients before starting the study and two weeks after the last session.
Patient satisfaction score will be assessed before starting the study and two weeks after the last session.
Patient evaluation (clinical percentage of improvement).
Operation :
One side of the affected area will be randomly assigned to fractional CO2 laser every four weeks for three months. The other side will be assigned to Q-switched Nd:YAG laser every four weeks for three months.
Method of randomization:
Using closed envelopes containing cards with fractional CO2 Rt and fractional CO2 Lt and the patient will draw one of them blindly. The assessment will be done by blinded investigator. Post-operative: Patients will be instructed to avoid sun exposure for one week after the session and regular use of sun block in between sessions.
Detailed Description
This prospective randomized comparative split study will be conducted at the outpatient clinic, Dermatology department, Faculty of Medicine, Cairo University and will include 20 patients with acanthosis nigricans in otherwise healthy individuals which will be recruited and assessed for eligibility for inclusion according to the above criteria. -Evaluation:
All patients will be subjected to the following:
Pre-operative preparation:
Informed written consent will be taken from every patient prior to the study. Detailed history taking including onset, course, duration of the disease and occupation (sun-exposed or not), predisposing factors, history of keloid tendency, associated diseases and previous treatments.
Assessment of skin type, BMI, degree of AN, HbA1C, site of lesions in all patients and degree of improvement.
Photography: will evaluate the clinical response to treatment for each patient Photos will be taken before starting the study, before every session, and two weeks after the last session.
Melanin index (MI) will be measured using reflectance spectrophotometer in order to assess the degree of hyperpigmentation before starting the study and two weeks after the last session. Research Template 8 Final Version: April 2019 Acanthosis Nigricans Area and Severity Index (ANASI) score (Zaki et al., 2018) will be done for all patients before starting the study and two weeks after the last session.
Patient satisfaction score will be assessed before starting the study and two weeks after the last session.
Patient evaluation (clinical percentage of improvement).
Operation :
One side of the affected area will be randomly assigned to fractional CO2 laser every four weeks for three months. The other side will be assigned to Q-switched Nd:YAG laser every four weeks for three months.
Method of randomization:
Using closed envelopes containing cards with fractional CO2 Rt and fractional CO2 Lt and the patient will draw one of them blindly. The assessment will be done by blinded investigator.
Post-operative: Patients will be instructed to avoid sun exposure for one week after the session and regular use of sun block in between sessions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acanthosis Nigricans
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 group of 20 patients doing both types of lasers on 2 sites
Arm Type
Other
Arm Description
comparing both types of laser
Intervention Type
Device
Intervention Name(s)
co2 laser
Other Intervention Name(s)
NdYAG laser
Intervention Description
types of laser
Primary Outcome Measure Information:
Title
patient evaluation
Description
Acanthosis nigricans area and severity index is scoring system used to assess patients before the session and after the session to assess finally the improvement
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age more than 18 years old
both genders
skin type III to V
controlled diabetus
Exclusion Criteria:
pregnancy and lactation
scarring
active skin infections
endocrinal disorders
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
results and discussion can be shared
IPD Sharing Time Frame
after finishing the paper and will be always be available
IPD Sharing Access Criteria
through the pubmed
Learn more about this trial
Study of the Effect of Fractional co2 Laser Versus Q Switched:NdYAG Laser in the Treatment of Acanthosis Nigricans
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