Evaluation of the effect of microneedling and phenytoin cream on atrophic scars compared to microneedling

Evaluation of efficacy and safety of microneedling and phenytoin cream 1% compared to microneedling in atrophic scars caused by facial acne: a double-blind randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211108052997N1

Enrollment

Registered

2021-12-18

Start date

2021-12-31

Completion date

Unknown

Last updated

2022-01-11

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

Conditions

Atrophic Scars. Hypertrophic scar

Interventions

Intervention 1: Intervention group: The intervention group is patients suffering from Atrophic scar lesion. The intervention group will be treated with microneedling and 1% Phenytoin topical cream, ma

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Patients with atrophic facial acne scars aged 18-45 years Patients with skin type 1-4

Exclusion criteria

Exclusion criteria: Sensitivity to phenytoin. Patients who have received laser treatment in the last three months. Patients with active colloidal scar or active skin lesion at the injection site. History of malignancy or receiving chemotherapy.

Design outcomes

Primary

Measure	Time frame
Qualitative intensity of atrophic scar. Timepoint: 1-At the beginning of the study, 2- before the second turn 3- before the third turn. 4. Two months after the end of the treatment period. Method of measurement: Photography by visioface. Objective observation.Visioface a full face photographic method for facial skin analysis. It has an accurate software to take high resolution full face photos and allows faster image capture with automatic skin type classification. By processing these images, skin problems are identified.	—

Measure

Time frame

Qualitative intensity of atrophic scar. Timepoint: 1-At the beginning of the study, 2- before the second turn 3- before the third turn. 4. Two months after the end of the treatment period. Method of measurement: Photography by visioface. Objective observation.Visioface a full face photographic method for facial skin analysis. It has an accurate software to take high resolution full face photos and allows faster image capture with automatic skin type classification. By processing these images, skin problems are identified.

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Secondary

Measure	Time frame
Quantative intensity of atrophic scars. Timepoint: 1) At the beginning of the study. 2) Before the second turn 3) Before the third turn. 4) Two months after the end of the treatment period. Method of measurement: Determine the depth of the scar by shooting by visioface,Scoring with Baron and Goodman scale.;Adverse events. Timepoint: 1) At the beginning of the study. 2) Before the second turn 3) Before the third turn. 4) Two months after the end of the treatment period. Method of measurement: Patient report, physician diagnosis.;The rate of improvement of scar. Timepoint: 1) At the beginning of the study. 2) Before the second turn 3) Before the third turn. 4) Two months after the end of the treatment period. Method of measurement: Patient satisfaction, photography by visioface, physician diagnosis.	—

Measure

Time frame

Quantative intensity of atrophic scars. Timepoint: 1) At the beginning of the study. 2) Before the second turn 3) Before the third turn. 4) Two months after the end of the treatment period. Method of measurement: Determine the depth of the scar by shooting by visioface,Scoring with Baron and Goodman scale.;Adverse events. Timepoint: 1) At the beginning of the study. 2) Before the second turn 3) Before the third turn. 4) Two months after the end of the treatment period. Method of measurement: Patient report, physician diagnosis.;The rate of improvement of scar. Timepoint: 1) At the beginning of the study. 2) Before the second turn 3) Before the third turn. 4) Two months after the end of the treatment period. Method of measurement: Patient satisfaction, photography by visioface, physician diagnosis.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Afsaneh Sadeghzadeh Bazarghan

Iran University of Medical Sciences

Sadeghzadeh.a@iums.ac.ir+98 21 6651 7341

Outcome results

None listed

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