Post-inflammatory hyperpigmentation Skin and Connective Tissue Diseases
Conditions
Interventions
At Baseline (Day 1), each participant who fulfilled all inclusion/exclusion criteria was assigned a Randomization Number. This Randomization Number was dispensed in the chronological order of her/his
a technique long used in dermatological research to induce superficial epidermal damage that disrupts the cutaneous epithelial barrier and stimulates various biological responses in the skin. PIHP wou
Sponsors
Isdin (Spain)
Eligibility
Sex/Gender
All
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Signed an informed consent form (ICF) 2. Healthy male or female aged 20 to 50 years inclusive with a known history of PIHP after intense sun exposure 3. Phototype IV or V according to the Fitzpatrick classification 4. Female of non-childbearing potential, defined as a woman without uterus and/or both ovaries, surgically sterile (at least 6 months prior to the Screening visit) or post-menopausal (at least 1 year post cessation of menses) 5. Female of childbearing potential who has been, in the opinion of the Investigator, using an approved method of birth control for at least 1 month prior to the Screening visit and agrees to continue adequate contraception during the entire study period. Reliable methods of contraception are: 5.1. Hormonal method or intrauterine device in use since at least 1 month prior to the Screening visit and during the investigation period 5.2. Bilateral tubal ligation since at least 3 months prior to the Screening visit 5.3. Barrier methods in use for at least 14 days prior to the Screening visit 5.4. Vasectomized partner 5.5. Sexual abstinence, defined as refraining from heterosexual intercourse for at least 3 months prior to the Screening visit and during the entire period of risk associated with the study products 6. Had not been exposed to UV radiation (tanning beds, phototherapy, and sunlight) on the whole body for at least two months before the screening visit and agreed to avoid exposure for the whole duration of the study 7. Agreed not to bathe (no baths or swimming) during the whole study period 8. Agreed not to apply cosmetic, medical, or aesthetic treatments out of the study protocol on the back during the whole study period 9. Affiliated to a health social security system (according to French Law)
Exclusion criteria
Exclusion criteria: 1. Female who was pregnant, parturient or breastfeeding 2. Female of childbearing potential who had a positive urinary pregnancy test at Day 1 3. Had a medical history/condition or was taking medication that could put him or her at undue risk or may have interfered with the study results 4. Had known or suspected allergies or sensitivities to any of the components of the study product 5. Had a recent history of (within the last 3 months) or with an active pityriasis versicolor 6. Excessive number of naevi, freckles, lentigines in test area site (middle back) 7. Had taken a systemic treatment, able to induce an abnormal response to UV, for more than 5 days during the month preceding inclusion (steroids, non-steroidal anti-inflammatories, insulin, anti-hypertensives, antibiotics such as quinolones, tetracyclines, thiazides and fluoroquinolones, and all other photosensitizing treatments), or any treatment capable of inducing an abnormal response to UV or VL (e.g., vitamin A derivatives, psoralen, aminolevulinic acid derivatives), or who planned to take these treatments during the study 8. Protected subject, as defined in the Articles of the French Public Health Code. Article 1121-7: person deprived of liberty by a judicial or administrative decision, or subject to psychiatric care, or person admitted to a health or social institution for purposes other than the research. Article 1121-8: adult person subject to a legal protection measure or unable to express his/her consent; 9. Unable to communicate with or cooperate with the Investigator 10. Currently participating in another clinical study, or who was in an exclusion period of another clinical study 11. Had received 6.000 euros indemnities for participation in clinical trials/investigations in the previous 12 months, including participation in the present study (in accordance with French Law)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin color (Individual Typology Angle [ITA°], Delta L*, Delta a*, Delta b*, Delta E*) measured using Chromameter CR 400 on baseline, Day 3, Day 5, Day 8, Day 15, Day 22 and Day 36 and before any product application | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Erythema is measured by clinical score on baseline, Day 3, Day 5, Day 8, Day 15, and before any product application 2. Pigmentation is measured by clinical score on baseline, Day 3, Day 5, Day 8, Day 15, and before any product application | — |
Countries
France
Contacts
Public ContactMarta Furmanczyk
Outcome results
None listed