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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:
Informed written consent will be taken from every patient including the study.
Detailed history including onset, course, duration of the disease and occupation, predisposing factors, associated diseases and previous treatments.
Outcome will be done at baseline, after the last session and 2 months after the last session:
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.
A.Epidermis: Epidermal thickness and presence of rete ridges B.Dermis: Papillary dermal edema, dermal vascularity, and presence of skin appendages.
C.Collagen fibers will be assessed for its thickness, commenting on whether it's fibrillar, fine thickness, normal thickness or sclerotic, besides the presence of perpendicular blood vessels towards the epidermis.
D.Elastic 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,
= weak (1-24% improvement in striae),
= moderate (25-49% improvement in striae),
= good (50-74%improvement in striae)
= excellent (75-100% improvement in striae)
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,
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 2.5-5 J/cm2, pulse duration of 0.5 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 cc/sec. 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 1.5 cm spacing between each injection point.
Each patient will be received 4 sessions with 4 weeks' intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single group 20 patients subjected PDL on one randomized side and carboxytherapy on the other side | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulsed dye laser | Device | PDL (Cynosure - Chelmsford, MA-USA) wavelength 585 nm at a fluence 2.5-5 J/cm2, pulse duration of 0.5 ms and spot size 7 -10 mm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Evaluation(mVSS Score, blinded investigators evaluation) |
Two independent blinded investigators will be assessed clinical improvement. Assessment of the standardized photographs using the following score: -1 = worse, 0 = no change,
| 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rawan barakat Saleh, M.B.B.Ch. | Contact | +20155-407-3917 | barakat_rawan@icloud.com |
| Name | Affiliation | Role |
|---|---|---|
| Rana Fathy Helal, assistant professor | Cairo University | Principal Investigator |
| Aya mohamed fahim, assistant professor | Cairo University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29316152 | Result | Hodeib AA, Hassan GFR, Ragab MNM, Hasby EA. Clinical and immunohistochemical comparative study of the efficacy of carboxytherapy vs platelet-rich plasma in treatment of stretch marks. J Cosmet Dermatol. 2018 Dec;17(6):1008-1015. doi: 10.1111/jocd.12481. Epub 2018 Jan 7. | |
| 24852467 | Result | Shokeir H, El Bedewi A, Sayed S, El Khalafawy G. Efficacy of pulsed dye laser versus intense pulsed light in the treatment of striae distensae. Dermatol Surg. 2014 Jun;40(6):632-40. doi: 10.1111/dsu.0000000000000007. |
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results and discussion can be shared
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after finishing the paper and and will be always available
through the pubmed
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| ID | Term |
|---|---|
| D057896 | Striae Distensae |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054025 | Lasers, Dye |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Carboxytherapy | Device | carboxytherapy (Carbo - Programmable automatic carbon dioxide therapy apparatus, MA-USA) that was automatically calibrated to adjust the flow rate, through regulation of infusion pressure and the dosage of CO2 in ml. the infusion velocity consequently was adjusted to a flow rate of 1 cc/. The injection 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 1.5 cm spacing between each injection point. End point was skin distension with the gas giving the characteristic "popcorn appearance". |
|