Erythema, Skin Recovery
Conditions
Keywords
Skin cream, Ablative lasering, Skin hydration, Consumer satisfaction, Sensorial perception
Brief 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.
Detailed 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.
Interventions
DRUGBAY207543 (Bepanthol)
Product is applied to one hemiface.
OTHERSemisolid vaseline
Product is applied to one hemiface.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin barrier integrity by TEWL probe | Up to 23 days | The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300. |
| Dermic temperature by thermographic camera (FLIR) | Up to 23 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Product evaluation | Up to 23 days | 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). |
| Number of adverse events by dermatological evaluation | Up to 23 days | — |
| Skin properties of the participants | 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 8 to 55 (a higher score represents higher efficacy). |
| Severity of adverse events by dermatological evaluation | Up to 23 days | — |
| Severity of adverse events by ophthalmologic valuation | Up to 23 days | — |
| Number of adverse events by ophthalmologic valuation | Up to 23 days | — |
| Treatment satisfaction | Up to 23 days | 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). |
Countries
Brazil
Outcome results
None listed