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

NCT ID: NCT03852563

Last Updated: 2020-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-18

Study Completion Date

2019-04-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this study, researchers want to learn more about the effect of dexpanthenol cream on skin recovery and reduction of skin rash after a dermatological procedure (ablative laser) on the face for treatment of fine wrinkles, scars and open pores in adult women.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective is to evaluate the efficacy of the test product to aid skin recovery and reduction of erythema after 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Erythema Skin Recovery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Women_Hemiface BAY207543

Adult women receive BAY207543 randomized to one hemiface and semisolid vaseline to the other hemiface after ablative skin lasering. The hemiface with BAY207543 is investigated.

Group Type EXPERIMENTAL

BAY207543 (Bepanthol)

Intervention Type DRUG

Product is applied to one hemiface.

Semisolid vaseline

Intervention Type OTHER

Product is applied to one hemiface.

Women_Hemiface Vaseline

Adult women receive BAY207543 randomized to one hemiface and semisolid vaseline to the other hemiface after ablative skin lasering. The hemiface with vaseline is investigated.

Group Type ACTIVE_COMPARATOR

BAY207543 (Bepanthol)

Intervention Type DRUG

Product is applied to one hemiface.

Semisolid vaseline

Intervention Type OTHER

Product is applied to one hemiface.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BAY207543 (Bepanthol)

Product is applied to one hemiface.

Intervention Type DRUG

Semisolid vaseline

Product is applied to one hemiface.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Phototypes I or II according to the Fitzpatrick scale
* Participants willing to perform the dermatological procedure (ablative laser) on the face for treatment of fine wrinkles, scars and open pores, rosacea
* 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 and cutaneous marks 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
* People with entropy, ectropion, stye, conjunctivitis, uveitis or other active eye diseases
* People with corneal ulcerations, blepharitis, meibomitis, pterygium, trichiasis, distichiasis or other eye diseases of moderate or serious intensity
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medcin Instituto da Pele

São Paulo, , Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Related Links

Access external resources that provide additional context or updates about the study.

https://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20577

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.