Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06591208
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Study the Effect of Pulsed Dye Laser Versus Carboxytherapy in the Treatment of Striae Rubra
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study the Effect of Pulsed Dye Laser Versus Carboxytherapy in the Treatment of Striae Rubra
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical intrapatient randomized trial will be conducted on 20 patients of both genders complaining from bilateral symmetrical striae rubra They will be recruited from Outpatient Clinic of Dermatology Department of Cairo University Hospitals All included patients will be subjected to
1 Informed written consent will be taken from every patient including the study
2 Detailed history including onset course duration of the disease and occupation predisposing factors associated diseases and previous treatments
3 Outcome will be done at baseline after the last session and 2 months after the last session
Photographing documentation two photographs in appropriate views will be taken on two occasions before each session Baseline and 2 months after the last treatment session
Modified Vancouver Scar Scale The modified Vancouver Scar Scale mVSS 1 evaluates four indicators vascularity pigmentation pliability and height It has a score ranging from 0-13 The modified Vancouver Scar Scale mVSS 2 evaluates three indicators vascularity pliability and height It has a score ranging from 0-10
Dermaspectrometer Dermaspectrometer will be measure erythema index at baseline after the last session and 2 months after the last session
Histopathological Assessment Skin biopsies using 4 mm punch biopsies will be obtained from SR before treatment baseline and 2 months after the last treatment sessions The post-treatment biopsy will be taken from the vicinity of the baseline biopsy Tissues will be fixed in 10 buffered formalin will be embedded in paraffin and will be sectioned into 5 µm-thick sections Specimens will be stained with hematoxylin and eosin H ampamp E andor Orcein for demonstration of elastic fibers Histological evaluations will be carried out under a light microscopy
Pathologic assessment for the stria will be evaluated each of the epidermis dermis collagen fibers and elastic fibers Degree of improvement will be assessed by examining the following criteria
AEpidermis Epidermal thickness and presence of rete ridges BDermis Papillary dermal edema dermal vascularity and presence of skin appendages
CCollagen fibers will be assessed for its thickness commenting on whether its fibrillar fine thickness normal thickness or sclerotic besides the presence of perpendicular blood vessels towards the epidermis
DElastic fibers will be evaluated it through Orcein stain for its presence or absence its thickness if present fragmented or fibrillar
Blinded investigator evaluation
Two independent blinded investigators will be assessed clinical improvement Assessment of the standardized photographs using the following score
-1 worse 0 no change
1 weak 1-24 improvement in striae
2 moderate 25-49 improvement in striae
3 good 50-74improvement in striae
4 excellent 75-100 improvement in striae
Patients satisfaction
The patients self-satisfaction for each modality of treatment regarded improvement and side effects of each modality measured on a five-point scale
0 not satisfied
1 moderately satisfied
2 satisfied Treatment Protocol Twenty patients will be subjected to Pulsed Dye Laser PDL on one randomized side of their bodies and carboxytherapy on the other side for four sessions with four weeks interval between sessions Randomization will be done through picking red PDL yellow carboxytherapy cards
After taking photographs patients will be locally anesthetized by topical lidocaine under occlusion for 1 h on the side of carboxytherapy The cream will be wiped off with a wet gauze when the session started Protective eye wear will be provided to the patient treating doctor and all the personnel assisting the procedure
One randomized side of the affected area will be assigned to PDL Cynosure - Chelmsford MA-USA with wavelength 585 nm at a fluence 25-5 Jcm2 pulse duration of 05 ms and spot size 7 -10 mm according to the width of the striae
The other side will be assigned to carboxytherapy Carbo - Programmable automatic carbon dioxide therapy apparatus MA-USA that will be automatically calibrated to adjust the flow rate through regulation of infusion pressure and the dosage of CO2 in ml the infusion velocity consequently will be adjusted to a flow rate of 1 ccsec The injection will be performed slowly subcutaneously by tilting the needle at 15 degree using a sterile disposable insulin needle with the depth adjusted at 2 mm the gas volume per injection spot is 2ml with 15 cm spacing between each injection point
Each patient will be received 4 sessions with 4 weeks intervals
1 Informed written consent will be taken from every patient including the study
2 Detailed history including onset course duration of the disease and occupation predisposing factors associated diseases and previous treatments
3 Outcome will be done at baseline after the last session and 2 months after the last session
Photographing documentation two photographs in appropriate views will be taken on two occasions before each session Baseline and 2 months after the last treatment session
Modified Vancouver Scar Scale The modified Vancouver Scar Scale mVSS 1 evaluates four indicators vascularity pigmentation pliability and height It has a score ranging from 0-13 The modified Vancouver Scar Scale mVSS 2 evaluates three indicators vascularity pliability and height It has a score ranging from 0-10
Dermaspectrometer Dermaspectrometer will be measure erythema index at baseline after the last session and 2 months after the last session
Histopathological Assessment Skin biopsies using 4 mm punch biopsies will be obtained from SR before treatment baseline and 2 months after the last treatment sessions The post-treatment biopsy will be taken from the vicinity of the baseline biopsy Tissues will be fixed in 10 buffered formalin will be embedded in paraffin and will be sectioned into 5 µm-thick sections Specimens will be stained with hematoxylin and eosin H ampamp E andor Orcein for demonstration of elastic fibers Histological evaluations will be carried out under a light microscopy
Pathologic assessment for the stria will be evaluated each of the epidermis dermis collagen fibers and elastic fibers Degree of improvement will be assessed by examining the following criteria
AEpidermis Epidermal thickness and presence of rete ridges BDermis Papillary dermal edema dermal vascularity and presence of skin appendages
CCollagen fibers will be assessed for its thickness commenting on whether its fibrillar fine thickness normal thickness or sclerotic besides the presence of perpendicular blood vessels towards the epidermis
DElastic fibers will be evaluated it through Orcein stain for its presence or absence its thickness if present fragmented or fibrillar
Blinded investigator evaluation
Two independent blinded investigators will be assessed clinical improvement Assessment of the standardized photographs using the following score
-1 worse 0 no change
1 weak 1-24 improvement in striae
2 moderate 25-49 improvement in striae
3 good 50-74improvement in striae
4 excellent 75-100 improvement in striae
Patients satisfaction
The patients self-satisfaction for each modality of treatment regarded improvement and side effects of each modality measured on a five-point scale
0 not satisfied
1 moderately satisfied
2 satisfied Treatment Protocol Twenty patients will be subjected to Pulsed Dye Laser PDL on one randomized side of their bodies and carboxytherapy on the other side for four sessions with four weeks interval between sessions Randomization will be done through picking red PDL yellow carboxytherapy cards
After taking photographs patients will be locally anesthetized by topical lidocaine under occlusion for 1 h on the side of carboxytherapy The cream will be wiped off with a wet gauze when the session started Protective eye wear will be provided to the patient treating doctor and all the personnel assisting the procedure
One randomized side of the affected area will be assigned to PDL Cynosure - Chelmsford MA-USA with wavelength 585 nm at a fluence 25-5 Jcm2 pulse duration of 05 ms and spot size 7 -10 mm according to the width of the striae
The other side will be assigned to carboxytherapy Carbo - Programmable automatic carbon dioxide therapy apparatus MA-USA that will be automatically calibrated to adjust the flow rate through regulation of infusion pressure and the dosage of CO2 in ml the infusion velocity consequently will be adjusted to a flow rate of 1 ccsec The injection will be performed slowly subcutaneously by tilting the needle at 15 degree using a sterile disposable insulin needle with the depth adjusted at 2 mm the gas volume per injection spot is 2ml with 15 cm spacing between each injection point
Each patient will be received 4 sessions with 4 weeks intervals
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None