Efficacy Of Combined Microneedling Plus Tretinoin In Treatment Of Stria Rubra

NCT07154030 | Not Yet Recruiting Phase 1

• 1 other identifier: Soh-Med-25-7-7MS
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Striae distensae (SD), commonly known as stretch marks, are linear dermal scars accompanied by epidermal atrophy . They are often associated with psychological morbidity with a negative impact on quality of life .They are mainly caused by marked stretching in the skin leading to dermal damage and epidermal thinning, leading to linear atrophic scars . Stretch marks are more common in women , their prevalence in puberty range from 6% to 86% and in obesity, it is 43%. Striae gravidarum (SG), (stretch marks of pregnancy) range between 50% and 90% ,and are more common in younger women.

Conditions

Striae

Keywords

Timolol; Tretinoin; Stria Rubra; Microneedling

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of combined microneedling plus tretinoin 0.025% or timolol 0.5% in treatment of stria rubra by noticing gradual changes in the appearance of skin and continuous photographing the site of lesion to notice the physiological changes

  Evaluate the efficacy of combined microneedling plus tretinoin 0.025% or timolol 0.5% in treatment of stria rubra by noticing gradual changes in the appearance of skin and continuous photographing the site of lesion to notice the physiological changes

  12 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

microneedling plus tretinoin 0.025%

Procedure: Micro needle injection; Procedure: Micro needle injection only

Group 2

EXPERIMENTAL

microneedling plus timolol 0.5%

Procedure: Micro needle injection; Procedure: Micro needle injection only

Interventions

Micro needle injection PROCEDURE

* Disinfection: the affected area by alcohol 70 %. * Topical anaesthetic cream will be applied: pridocaine (lidocaine 2.5% and prilocaine 2.5%) for 30 minutes under occlusion. * Microneedling with tretinoin 0.025% of the affected area will be done by dermapen that will be applied on the affected area as follows: inserting the sterilized needle into the dermapen tip, turning on using speed setting and adjusting speed on 5, needle depth of dermapen will be adjusted to (2- 2.5mm) according to the site of the striae, passing vertically over the striae with dermapen in a stamping pattern until pin point bleeding appear.

Group 1; Group 2

Micro needle injection only PROCEDURE

* Disinfection: the affected area by alcohol 70 %. * Topical anesthetic cream will be applied: pridocaine (lidocaine 2.5% and prilocaine 2.5%) for 30 minutes under occlusion. * Microneedling with timolol 0.5% of the affected area will be done by derma pen that will be applied on the affected area as follows: inserting the sterilized needle into the derma pen tip, turning on using speed setting and adjusting speed on 5, needle depth of derma pen will be adjusted to (2- 2.5mm) according to the site of the striae, passing vertically over the striae with derma pen in a stamping pattern until pin point bleeding appear.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The study will include patients with stria rubra aged ≥18

You may not qualify if:

• \- 1.Pregnant \& lactating patients. 2.Patients with bleeding disorders or on anticoagulant therapy. 3.Patients using drugs that exacerbate the striae as systemic corticosteroids in the preceding two months or topical corticosteroid in the preceding one month.
• Patients having active infection at the treatment area. 5.Patients with keloidal tendency. 6.Patients using other forms of treatment for stria as emollients, glycolic acid peel and laser over the last 2 months.

Sponsors & Collaborators

• Sohag University: lead

Related Links

• Related Info

MeSH Terms

Conditions

Striae Distensae

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kholoud Moustafa Hashem, demonstator

CONTACT

+201092533978; kholed011080@med.sohag.edu.eg

Zeinab baha Gouda, lecturer

CONTACT

zainb.aboelbaha@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: demonstrator od dermatology

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: September 4, 2025
• Study Start: September 5, 2025
• Primary Completion: November 30, 2025
• Study Completion (Estimated): September 5, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share