Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel in Preventing Hypertrophic Scars

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHerbarium Laboratorio Botanico Ltda

About this trial

Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use, comparing it to a benchmark for preventing hypertrophic scars and improving appearance, hydration and pigmentation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants of both sexes aged between 18 and 70 years;

Participants with recent scars (<30 days);

Participants with phototypes III to VI according to the Fitzpatrick scale;

Agree to follow the trial procedures and attend the center on the days and times determined for evaluations;

Disqualifiers

Pregnancy or risk of pregnancy;

History of atopic or allergic reactions to cosmetic products;

Participants who are using topical antibiotics or other skin products on the same area being evaluated;

Immunosuppression due to drugs or active diseases;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Scar gel

    Device

    Health care product (scar gel)

  • Scar gel comparator

    Device

    Health care product (Scar gel comparator)

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Participants of both sexes, 18 - 70 yActive comparator 1 intervention
Group B: Exp.: Participants of both sexes, 18 - 70 yExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Assessment of clinical and perceived efficacy

Evaluate the prevention of hypertrophic scars after 90 days of continuous use of the investigational product. The dermatologist will perform assessments of the clinical parameters using the POSAS scale.

Time frame
90 days

Secondary outcomes

1

Perceived efficacy

To compare the treatments of the benchmark product versus the investigational product in improving the appearance of scars, discomfort, skin hydration, itching and normalization of scar pigmentation, after 90 days of use, through a questionnaire on perceived efficacy.

Time frame
90 days

Other outcomes

Sponsors and contacts

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