Skip to main content
OpenTrials
Completed

NCT Number: NCT03853538

A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Face Skin to Recover After Cosmetic Lasering

In this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery and reduction of skin redness after a dermatological procedure (non-ablative laser) on the face for treatment of fine wrinkles, scars, open pores and change of pigmentation.

After the dermatological procedure, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such redness, irritation, softness and possible side effects. In addition, study participants will be asked about their general acceptance of dexpanthenol dermal spray.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Erythema Behavior Consumer Behavior Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin Recovery Skin and Connective Tissue Diseases

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Medcin Instituto da Pele

São Paulo, 06023-070, Brazil

About this study

The primary objective is to evaluate the efficacy of the test product to aid skin recovery and reduction of erythema after non-ablative lasering on the face.

Secondary objectives comprise clinical efficacy with respect to skin hydration, softness, vitality, appearance etc. and skin recovery, consumer judgement of product performance and acceptability, and safety.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Phototypes I or II according to the Fitzpatrick scale
  • Participants willing to perform the dermatological procedure (non-ablative laser) on the face for treatment of fine wrinkles, scars and open pores, rosacea, poikiloderma, and melasma
  • Normal eye examination

Exclusion criteria

  • Cutaneous pathologies and/or injuries as psoriasis, sensible skin, cancer of the skin, rosacea, atopic dermatitis or other medical criteria to be considered at the moment of the evaluation;
  • Hyperpigmentation in the test area that intervenes with the evaluation of possible reactions
  • Active cutaneous pathologies and/or injuries (local and/or disseminated) in the evaluation area
  • Aesthetic or dermatological treatment in the area of evaluation up to 04 weeks before the selection

Treatment and study plan

BAY207543 (Bepanthol, Bepantol® Derma Spray)

Drug

Product is applied to one hemiface.

Semisolid vaseline

Other

Product is applied to one hemiface.

Primary outcomes

  1. Transepidermal water loss by TEWL probe

    Time frame: Up to 23 days

    The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300.

  2. Dermic temperature by thermographic camera (FLIR T530sc)

    Time frame: Up to 23 days

Secondary outcomes

  1. Skin properties of the participants

    Time frame: Up to 23 days

    Investigators assess various skin properties of the participants with a questionnaire (each scored from 1 to 5), resulting in an overall efficacy score from 9 to 45 (a higher score represents higher efficacy).

  2. Treatment satisfaction

    Time frame: Up to 23 days

    Participants assess their treatment satisfaction with a questionnaire consisting of 13 items (each item is scored from 1-5) resulting in a score range of 13 to 65 (a higher score represents better treatment satisfaction).

  3. Product evaluation

    Time frame: Up to 23 days

    Participants assess their sensorial perception of different product attributes (e.g. smell, absorption) with a questionnaire consisting of 6 items (each item is scored from 1-5) resulting in a score range from 6 to 30 (a higher score represents higher product satisfaction).

  4. Number of adverse events by dermatological evaluation

    Time frame: Up to 23 days

  5. Number of adverse events by ophthalmologic valuation

    Time frame: Up to 23 days

  6. Severity of adverse events by dermatological evaluation

    Time frame: Up to 23 days

  7. Severity of adverse events by ophthalmologic valuation

    Time frame: Up to 23 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Evaluation of the Safety and Efficacy of the Product Bepantol® Derma Spray After the Dermatological Procedure in the Face - 21 Days of Follow-up.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 25, 2019
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.