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

NCT ID: NCT03853538

Last Updated: 2020-03-09

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-28

Study Completion Date

2019-03-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Erythema Skin Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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, Bepantol® Derma Spray)

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 the test product 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, Bepantol® Derma Spray)

Intervention Type DRUG

Product is applied to one hemiface.

Semisolid vaseline

Intervention Type OTHER

Product is applied to one hemiface.

Interventions

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BAY207543 (Bepanthol, Bepantol® Derma Spray)

Product is applied to one hemiface.

Intervention Type DRUG

Semisolid vaseline

Product is applied to one hemiface.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medcin Instituto da Pele

São Paulo, , Brazil

Site Status

Countries

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Brazil

Related Links

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https://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

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20505

Identifier Type: -

Identifier Source: org_study_id

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