Fractional Carbon Dioxide Laser: A Novel Therapeutic Option for Lichen Simplex Chronicus

NCT06267066 | Not Yet Recruiting

• 1 other identifier: MD-232-2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this randomized control trial is to compare the use of fractional carbon dioxide (Co2) laser to topical corticosteroids to treat lichen simplex chronicus (LSC) patients presenting to Dermatology outpatient clinic, Faculty of Medicine, Cairo University. Participants will:

• Be assessed clinically by doctor
• Biopsies will be taken from them by doctor
• Receive treatment as laser or topical steroids or both
• Fill in depression questionnaire. Researchers will divide and compare groups as follows: Sixty patients will be divided randomly through closed envelop technique into 2 groups (Group A and B) each of 30 patients. Group A will be subdivided into 2 groups (1 and 2). All LSC lesions will be treated in any patient having multiple lesions.
• Group 1 - A: Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions.
• Group 2 - A: Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions.
• Group B: Patients will be prescribed topical steroids twice daily and topical emollient once daily for 3 months. to see if:
• Pruritus severity scale.
• Scaling, erythema, lichenification excoriation scores
• Visual analogue scale.
• Investigator's Global Assessment.
• Itching mediators (Interleukin-31, Nerve Growth Factor and Substance P assays (itching mediators)
• Depression

Conditions

Lichen Simplex Chronicus

Keywords

Lichen Simplex Chronicus; Fractional carbon dioxide laser; Depression; Interleukin 31; Nerve Growth Factor; Substance P

Outcome Measures

Primary Outcomes (7)

• Comparison between 2 groups regarding change in Pruritus severity scale

  Minimum value: 3 , Maximum value: 22 , higher scores mean a worse outcome.

  through study completion, an average of 5months

• Comparison between 2 groups regarding change in Visual analogue scale

  Minimum value:0 , Maximum value: 10, higher scores mean a worse outcome.

  through study completion, an average of 5months

• Comparison between 2 groups regarding change in Investigator's Global Assessment.

  Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.

  through study completion, an average of 5months

• Comparison between 2 groups regarding change in Scaling score

  Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.

  through study completion, an average of 5months

• Comparison between 2 groups regarding change in Erythema score

  Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.

  through study completion, an average of 5months

• Comparison between 2 groups regarding change in Lichenification score

  Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.

  through study completion, an average of 5months

• Comparison between 2 groups regarding change in Excoriation score

  Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.

  through study completion, an average of 5months

Secondary Outcomes (3)

• change of depression score in both groups.

  through study completion, an average of 5months

• change of itching mediators' levels (IL-31, Nerve Growth Factor and substance) between 2 groups

  through study completion, an average of 5months

• Comparison of itching mediator's levels in lesional, non-lesional skin and healthy controls

  through study completion, an average of 5months

Study Arms (3)

Topical Corticosteroids

ACTIVE COMPARATOR

Patients will be prescribed topical steroids cream twice daily and topical emollient once daily for 3 months.

Drug: Betamethasone Valerate 0.1% Cream; Drug: Vaseline Topical Product

Fractional carbon dioxide

ACTIVE COMPARATOR

Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions.

Device: SmartXide® fractional carbon dioxide laser; Drug: Vaseline Topical Product

Combined topical corticosteroids and Laser

ACTIVE COMPARATOR

Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions.

Drug: Betamethasone Valerate 0.1% Cream; Device: SmartXide® fractional carbon dioxide laser; Drug: Vaseline Topical Product

Interventions

Betamethasone Valerate 0.1% Cream DRUG

Moderate potency

Combined topical corticosteroids and Laser; Topical Corticosteroids

SmartXide® fractional carbon dioxide laser DEVICE

Ablative

Combined topical corticosteroids and Laser; Fractional carbon dioxide

Vaseline Topical Product DRUG

Emollient

Combined topical corticosteroids and Laser; Fractional carbon dioxide; Topical Corticosteroids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with LSC with no underlying dermatological disease, not on topical or systemic treatment for at least 4 weeks prior to study.

You may not qualify if:

• Pregnant and lactating females.
• Patients who are diagnosed with any systemic disease that can result in generalized pruritus (e.g. hepatic, renal, uncontrolled diabetes mellitus, thyroid,….etc ) from history.
• Patients with contraindications to laser e.g., keloidal tendency, post inflammatory hyperpigmentation (PIH).
• Patients with dermatological disease (e.g. psoriasis, atopic dermatitis, ….etc)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Lobna Alieldin

Cairo, 11562, Egypt

Location

Lobna Alieldin

Cairo, 11562, Egypt

Location

Related Publications (1)

• Esmat S, Sany I, Alieldin L, Nour Z, Azzazi Y. Fractional Carbon Dioxide Laser for Lichen Simplex Chronicus: A Randomized Controlled Trial. Dermatol Surg. 2025 Aug 6. doi: 10.1097/DSS.0000000000004809. Online ahead of print.

  PMID: 40767880 DERIVED

MeSH Terms

Conditions

Neurodermatitis; Depression; Hereditary Sensory and Autonomic Neuropathies

Interventions

Betamethasone Valerate

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Behavioral Symptoms; Behavior; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Betamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Experienced dermatologist blinded to the interventions done will assess the patients' at the end of the treatment period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Sixty patients will be divided randomly through closed envelop technique into 2 groups (Group A and B) each of 30 patients. Group A will be subdivided into 2 groups (1 and 2) each of 15 patients. All LSC lesions will be treated in any patient having multiple lesions. Group 1 - A: Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions. Group 2 - A: Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions. Group B: Patients will be prescribed topical steroids twice daily and topical emollient once daily for 3 months.

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 20, 2024
• Study Start: March 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 30, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 months up to 12 months after publication.
• Access Criteria: Researches who provide a methodologically sound proposal to access data to achieve aims in the approved proposal.

Locations

EG (2)