Formulation of a topical gel containing Lawsonia inermis and Crocin and evaluation its effects on preventing radiation-induced dermatitis.

Formulation of a topical gel containing Lawsonia inermis and Crocin and evaluation its effects on preventing radiation-induced dermatitis in breast cancer patients: A randomized double-blinded placebo-controlled trial.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191106045356N20

Enrollment

Registered

2024-08-15

Start date

2024-08-21

Completion date

Unknown

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis. Dermatitis, unspecified

Interventions

Intervention 1: Intervention group: It includes 25 patients referred to the radiotherapy center who meet the inclusion criteria, whose order and type of intervention is random based on the RND () fun

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients starting radiotherapy Patients aged 18 to 65 years

Exclusion criteria

Exclusion criteria: Patients with skin diseases Allergy to henna or crocin Severe systemic diseases such as uncontrolled diabetes, epilepsy, immune system defects, etc.

Design outcomes

Primary

Measure	Time frame
Severity of erythema or redness. Timepoint: During and after treatment, every ten days, the skin condition undergoing radiotherapy is evaluated for the severity of redness, dryness, itching, burning and pain. Method of measurement: Scoring erythema or redness using a questionnaire.;Severity of itching. Timepoint: During and after treatment, every ten days, the skin condition undergoing radiotherapy is evaluated for the severity of redness, dryness, itching, burning and pain. Method of measurement: Scoring itching using a questionnaire.;Severity of pain. Timepoint: During and after treatment, every ten days, the skin condition undergoing radiotherapy is evaluated for the severity of redness, dryness, itching, burning and pain. Method of measurement: Scoring pain using a questionnaire.;Skin dryness score. Timepoint: During and after treatment, every ten days, the skin condition undergoing radiotherapy is evaluated for the severity of redness, dryness, itching, burning and pain. Method of measurement: Scoring skin dryness using a questionnaire.	—

Measure

Time frame

Severity of erythema or redness. Timepoint: During and after treatment, every ten days, the skin condition undergoing radiotherapy is evaluated for the severity of redness, dryness, itching, burning and pain. Method of measurement: Scoring erythema or redness using a questionnaire.;Severity of itching. Timepoint: During and after treatment, every ten days, the skin condition undergoing radiotherapy is evaluated for the severity of redness, dryness, itching, burning and pain. Method of measurement: Scoring itching using a questionnaire.;Severity of pain. Timepoint: During and after treatment, every ten days, the skin condition undergoing radiotherapy is evaluated for the severity of redness, dryness, itching, burning and pain. Method of measurement: Scoring pain using a questionnaire.;Skin dryness score. Timepoint: During and after treatment, every ten days, the skin condition undergoing radiotherapy is evaluated for the severity of redness, dryness, itching, burning and pain. Method of measurement: Scoring skin dryness using a questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Reza Lotfaliani

Yazd University of Medical Sciences

Lotf726@yahoo.com+98 35 3820 3419

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026