Evaluation of the Efficacy of Carboxytherapy in Controlling the Exacerbation of Acne Lesions in Patients with Acne Vulgaris Undergoing Oral Isotretinoin Treatment.

Assessment of Efficacy of Carboxytherapy in Management of Exacerbation of Inflammatory and Non-inflammatory Acne Lesions in Patients With Moderate to Severe Acne Vulgaris Under Treatment with Oral Isotretinoin

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250202064604N1

Enrollment

Registered

2025-09-13

Start date

2025-10-31

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Acne vulgaris. Acne vulgaris

Interventions

Intervention 1: Intervention group: Treatment in volunteers with moderate to severe acne is initiated at a dose of 0.5 mg of isotretinoin per kilogram of body weight, based on the presence of indicati

Eligibility

Sex/Gender

All

Age

15 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 15 years Presence of inflammatory and non-inflammatory acne lesions in the facial area on both sides Absence of medication for 6 weeks prior to study start Consent to participate in the study Both genders Initiation of treatment with isotretinion No concurrent use of systemic or topical medication for the treatment of acne lesions No smoking, alcohol consumption or drug abuse No pregnancy No breastfeeding No history of any systemic diseases No active skin infections in the area where carboxytherapy is performed No history of any connective tissue disease

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Count of whiteheads comedones. Timepoint: From the very first session, prior to each treatment session (from week one to week five). Method of measurement: The lesions are counted and recorded separately on both sides of the face.;Count of blackheads comedones. Timepoint: From the very first session, prior to each treatment session (from week one to week five). Method of measurement: The lesions are counted and recorded separately on both sides of the face.;Count of papules. Timepoint: From the very first session, prior to each treatment session (from week one to week five). Method of measurement: The lesions are counted and recorded separately on both sides of the face.;Count of pustules. Timepoint: From the very first session, prior to each treatment session (from week one to week five). Method of measurement: The lesions are counted and recorded separately on both sides of the face.;Count of cysts. Timepoint: From the very first session, prior to each treatment session (from week one to week five). Method of measurement: The lesions are counted and recorded separately on both sides of the face.;Total number of lesions. Timepoint: From the very first session, prior to each treatment session (from week one to week five). Method of measurement: The lesions are counted and recorded separately on both sides of the face.;Acne severity index. Timepoint: From the very first session, prior to each treatment session (from week one to week five). Method of measurement: Lesions are assessed and documented separately for each side of the face.;Patient satisfaction. Timepoint: Starting from the second session(from week two to week five). Method of measurement: The investigator administering the questionnaire asks the participant to report their subjective level of satisfaction with the treatment. The patient will be instructed to express their satisfaction as a percentage: 0% indicating no improvement, 1–25% indicating a poor response, 26–50% a moderate response, 51–75% a good	—

Measure

Time frame

Count of whiteheads comedones. Timepoint: From the very first session, prior to each treatment session (from week one to week five). Method of measurement: The lesions are counted and recorded separately on both sides of the face.;Count of blackheads comedones. Timepoint: From the very first session, prior to each treatment session (from week one to week five). Method of measurement: The lesions are counted and recorded separately on both sides of the face.;Count of papules. Timepoint: From the very first session, prior to each treatment session (from week one to week five). Method of measurement: The lesions are counted and recorded separately on both sides of the face.;Count of pustules. Timepoint: From the very first session, prior to each treatment session (from week one to week five). Method of measurement: The lesions are counted and recorded separately on both sides of the face.;Count of cysts. Timepoint: From the very first session, prior to each treatment session (from week one to week five). Method of measurement: The lesions are counted and recorded separately on both sides of the face.;Total number of lesions. Timepoint: From the very first session, prior to each treatment session (from week one to week five). Method of measurement: The lesions are counted and recorded separately on both sides of the face.;Acne severity index. Timepoint: From the very first session, prior to each treatment session (from week one to week five). Method of measurement: Lesions are assessed and documented separately for each side of the face.;Patient satisfaction. Timepoint: Starting from the second session(from week two to week five). Method of measurement: The investigator administering the questionnaire asks the participant to report their subjective level of satisfaction with the treatment. The patient will be instructed to express their satisfaction as a percentage: 0% indicating no improvement, 1–25% indicating a poor response, 26–50% a moderate response, 51–75% a good

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Same

Arak University of Medical Sciences

mohsensame98@gmail.com+98 86 3417 3532

Outcome results

None listed

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