Study the Effect of Pulsed Dye Laser Versus Carboxytherapy in the Treatment of Striae Rubra

NCT06591208 | Not Yet Recruiting DMC

• 1 other identifier: effect PDL vs carboxy on stria
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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:

• 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 \& E) and/or 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. 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)
• 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,
• → moderately satisfied,
• → 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.

Conditions

Striae Distensae

Outcome Measures

Primary Outcomes (1)

• Patient Evaluation(mVSS Score, blinded investigators evaluation)

  * 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 Assessment for all patients will be at baseline after last session, and 2 months after last session. * 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 (50-74%improvement in striae) 4. = excellent (75-100% improvement in striae

  6 months

Study Arms (1)

single group 20 patients subjected PDL on one randomized side and carboxytherapy on the other side

OTHER

Device: pulsed dye laser; Device: Carboxytherapy

Interventions

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

single group 20 patients subjected PDL on one randomized side and carboxytherapy on the other side

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".

single group 20 patients subjected PDL on one randomized side and carboxytherapy on the other side

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Both genders are included. 2. Patients above 18 years old. 3. Patients have bilateral symmetrical striae rubra lesions.

You may not qualify if:

• Pregnancy
• Scarring and keloid tendencies.
• Active skin infection, active infection of herpes simplex virus.
• Patient on Prior steroid therapy
• Patient have History of Cushing syndrome
• Patients with concomitant disease during the study (e.g., hepatic, renal, cardiac, autoimmune diseases, diabetes mellitus, and/or bleeding disorders).

Sponsors & Collaborators

• Cairo University: lead

Related Publications (2)

• 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.

  PMID: 29316152 BACKGROUND

• 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.

  PMID: 24852467 BACKGROUND

MeSH Terms

Conditions

Striae Distensae

Interventions

Lasers, Dye

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Rana Fathy Helal, assistant professor

  Cairo University

  PRINCIPAL INVESTIGATOR

• Aya mohamed fahim, assistant professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rawan barakat Saleh, M.B.B.Ch.

CONTACT

+20155-407-3917; barakat_rawan@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: September 11, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: after finishing the paper and and will be always available
• Access Criteria: through the pubmed