Skin Recovery
Conditions
Keywords
Dermal spray, Peeling, Skin hydration, Consumer satisfaction, Sensorial perception
Brief summary
In this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery after a dermatological procedure (peeling) in the intimate area of women. After the peeling, 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
The primary objective is to evaluate the efficacy of the test product to aid skin recovery after peeling in the female intima and inguinal region. 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
Product is applied to one side of the inguinal region.
OTHERSemisolid vaseline
Product is applied to the other side of the inguinal region.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Phototypes I and II according to the Fitzpatrick scale; * Participants willing to have peeling in the genital area to improve the general appearance of the skin and bleaching of spots.
Exclusion criteria
* Pathologies and/or skin injuries, such as psoriasis, sensitive skin, skin cancer, atopic dermatitis or other medical criteria to be considered at the time of evaluation * Hyperpigmentation in the test area that interfere with the evaluation of possible reactions (vascular malformations, scars, increase of pilosity and large amount of nevi) * Pathologies and/or active skin injuries (local and/or disseminated) in the evaluation area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transepidermal water loss by TEWL probe | Up to 23 days | The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment satisfaction | Up to 23 days | Participants assess their treatment satisfaction with a questionnaire consisting of 19 items (each item is scored from 1-5) resulting in a score range of 19 to 95 (a higher score represents better treatment satisfaction). |
| Product evaluation | 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). |
| 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 12 to 60 (a higher score represents higher efficacy). |
| Severity of adverse events by dermatological evaluation | Up to 23 days | — |
| Severity of adverse events by gynecological evaluation | Up to 23 days | — |
| Number of adverse events by gynecological evaluation | Up to 23 days | — |
Countries
Brazil
Outcome results
None listed