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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03852563
Other study ID # 20577
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 18, 2019
Est. completion date April 22, 2019

Study information

Verified date April 2020
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date April 22, 2019
Est. primary completion date April 22, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BAY207543 (Bepanthol)
Product is applied to one hemiface.
Other:
Semisolid vaseline
Product is applied to one hemiface.

Locations

Country Name City State
Brazil Medcin Instituto da Pele Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Skin barrier integrity by TEWL probe The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300. Up to 23 days
Primary Dermic temperature by thermographic camera (FLIR) Up to 23 days
Secondary Skin properties of the participants Investigators assess various skin properties of the participants with a questionnaire (each scored from 1 to 5), resulting in an overall efficacy score from 8 to 55 (a higher score represents higher efficacy). Up to 23 days
Secondary Treatment satisfaction Participants assess their treatment satisfaction with a questionnaire consisting of 23 items (each item is scored from 1-5) resulting in a score range of 23 to 115 (a higher score represents better treatment satisfaction). Up to 23 days
Secondary Product evaluation Participants assess their sensorial perception of different product attributes (e.g. smell, absorption) with a questionnaire consisting of 7 items (each item is scored from 1-5) resulting in a score range from 7 to 35 (a higher score represents higher product satisfaction). Up to 23 days
Secondary Number of adverse events by dermatological evaluation Up to 23 days
Secondary Number of adverse events by ophthalmologic valuation Up to 23 days
Secondary Severity of adverse events by dermatological evaluation Up to 23 days
Secondary Severity of adverse events by ophthalmologic valuation Up to 23 days
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