The Effectiveness of Topical Silicone Application Combined With Photoprotection in the Development of Scarring Following Blepharoplasty

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto de Oftalmología Fundación Conde de Valenciana

About this trial

Assess the efficacy of utilizing topical silicone with photoprotection (Improscar Stick® 50) on the quality of healing following upper blepharoplasty, employing the Vancouver and POSAS scales (both patient and observer) over a minimum follow-up period of three months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The study participants are individuals aged 18 years and older, encompassing both male and female subjects. These participants are undergoing blepharoplasty and have provided their written informed consent to partake in the research.

Disqualifiers

Individuals with a history of previous surgical procedures on the eyelids, apart from the current blepharoplasty. . Those who have previously undergone intralesional modulation are also considered. Individuals with a known allergy to any components of the product under investigation. The presence of local skin infections in the treatment area. Suspicious skin lesions suggestive of malignancy in the eyelid region. Pregnancy or breastfeeding during the study. - Research subjects who, after being included in the study, do not complete the scheduled clinical follow-up. Research subjects who discontinue the use of the topical treatment before the end of the established period. Voluntary withdrawal of informed consent at any stage of the study. Later detection of exclusion criteria that were not identified during the initial evaluation.

Trial design

Design model

Single group

Treatments tested in this trial

  • Silicone-based topical formulation with sunscreen (SPF 50) application

    Drug

    Silicone-based topical formulation with sunscreen (SPF 50), will be administered to the eyelid incisions of research participants who have undergone blepharoplasty.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Improscar Stick® 50, a silicone-based topical formulation with sunscreen (SPF 50) applicationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objetive evaluation

To objectively evaluate the quality of post-surgical eyelid scars, assessments will be conducted based on the Vancouver scale, focusing on vascularity, pigmentation, pliability, and height.

Time frame
From enrollment to the end of treatment at 3 months
2

Subjective evaluation

For subjective evaluation, the POSAS scale will be employed, which consists of two components: one completed by the research subject and the other by the clinical observer. Each component assesses six domains-color, thickness, relief, itching, and pain-using a scoring system ranging from 1 (normal skin) to 10 (worst possible outcome).

Time frame
From enrollment to the end of treatment at 3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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