Skin Recovery
Conditions
Keywords
Dermal spray, Laser depilation, 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 for hair removal (laser depilation) in the groin and intimate area in adult women. After the hair removal procedure, participants will return within 3 weeks for 3 visits to the study center to investigate the skin condition such as redness, irritation, softness of skin and possible side effects. Study participants will also 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 lasering depilation in the 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 one 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 a dermatological procedure (laser depilation) in the inguinal region to remove hairs in the region
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 * Hyperpigmentations 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 |
|---|---|---|
| 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 9 to 45 (a higher score represents higher efficacy). |
| Treatment satisfaction | Up to 23 days | Participants assess their treatment satisfaction with a questionnaire consisting of 13 items (each item is scored from 1-5) resulting in a score range of 13 to 65 (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 | — |
| Severity of adverse events by dermatological evaluation | Up to 23 days | — |
Countries
Brazil
Outcome results
None listed