Recruitment

Recruitment Status
Completed

Inclusion Criterias

The ability to complete the study and to comply with study instructions.
Two forms of non hormonal contraception, including intrauterine devices or properly used barrier methods (eg, male or female condoms, diaphragm, or cervical cap). Subjects with surgical sterilization, including tubal ligation or partner's vasectomy, were to have used a form of non-hormonal contraception. A barrier method or sterilization plus spermatocide were acceptable.
Possessed Fitzpatrick skin type I (always burns easily; never tans), II (always burns easily; tans minimally), or III (burns moderately; tans gradually) that would not interfere with the reading of any skin responses. Determination of skin types was based on sunburn and tanning histories, as well as subjects' opinions of their responses to the first 30 to 45 minutes of sun exposure.
...
The ability to complete the study and to comply with study instructions.
Two forms of non hormonal contraception, including intrauterine devices or properly used barrier methods (eg, male or female condoms, diaphragm, or cervical cap). Subjects with surgical sterilization, including tubal ligation or partner's vasectomy, were to have used a form of non-hormonal contraception. A barrier method or sterilization plus spermatocide were acceptable.
Possessed Fitzpatrick skin type I (always burns easily; never tans), II (always burns easily; tans minimally), or III (burns moderately; tans gradually) that would not interfere with the reading of any skin responses. Determination of skin types was based on sunburn and tanning histories, as well as subjects' opinions of their responses to the first 30 to 45 minutes of sun exposure.
Hormonal contraception, including oral, injectable, or implantable methods started at least 2 months prior to screening. If hormonal contraception was started less than 2 months prior to screening, then a form of non-hormonal contraception was to have been added until the third continuous month of hormonal contraception was completed.
The capability of understanding and providing signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed.
Male or female subjects aged from 18 to 65 years, inclusive, at time of consent.

Exclusion Criterias

Participated in a previous study of the same study product.
History of severe reactions from exposure to sunlight, including previous experience with photoallergy, solar urticaria, polymorphous light eruptions, or other photo exacerbated systemic diseases.
Used antihistamines or prescription anti inflammatory drugs within 72 hours of the day 1 visit. Permitted exceptions were acetaminophen at recommended doses and aspirin at doses of ≤81 mg/day.
...
Participated in a previous study of the same study product.
History of severe reactions from exposure to sunlight, including previous experience with photoallergy, solar urticaria, polymorphous light eruptions, or other photo exacerbated systemic diseases.
Used antihistamines or prescription anti inflammatory drugs within 72 hours of the day 1 visit. Permitted exceptions were acetaminophen at recommended doses and aspirin at doses of ≤81 mg/day.
Female subjects who were pregnant, attempting to become pregnant, or breast feeding.
Employees of Hill Top Research or Stiefel Laboratories involved in the study, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee involved in the study.
Investigator inability to evaluate the skin in and around the potential test sites due to sunburns, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin abnormalities.
Current use of any medication which, in the opinion of the investigator, may have affected the evaluation of the study product or placed the subject at undue risk.
Currently receiving allergy injections, or due to receive an injection, within 7 days prior to screening visit 1, or expected to begin injections during study participation.
Current use or expected use of photosensitizing medications (over-the-counter and prescription), herbal supplements, or any use of a known photosensitizing material.
Received any investigational drug within 4 weeks of study day 1 or who were scheduled to receive an investigational drug other than the study product during the study.
Used topical medications (eg, corticosteroids or immunosuppressives) on potential test sites within the last 7 days prior to screening visit 1.
Participated in any patch test study for irritation or sensitization or any test involving ultraviolet exposures within the last 4 weeks.
Clinically relevant history or presence of respiratory (including chronic asthma requiring repetitive drug interventions), gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders.
Clinically significant skin diseases contraindicating participation or interfering with test site evaluations, including psoriasis, eczema, atopic dermatitis, acne, dysplastic nevi, or other skin pathologies.
Currently diagnosed with cancer or had a previous history of cancer, including skin cancer, or severe photodamaged skin. Severe photodamaged skin was characterized by yellow-gray color, wrinkles with no visible normal skin, and prior skin malignancies.
Used contraindicated prescription drugs within 4 weeks or 5 half-lives, whichever was longer, of first dose of study product, unless agreed as not clinically relevant by the principal investigator and the project physician.
Considered immunocompromised or using immunosuppressant drugs.
Considered unable or unlikely to attend the necessary visits.
Suffered from any disease or condition which, in the opinion of the investigator, may have affected the evaluation of the study product or placed the subject at undue risk.
History of known or suspected intolerance to any of the ingredients of the study products (ie, test and comparator products), to the hypoallergenic tape, or to the cotton patches.
Clinically relevant history of or current evidence of abuse of alcohol or other drugs.
Any major illness within 30 days before the screening examination.

Summary

Conditions
Acne Vulgaris
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Single Group Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Inclusion Criterias

The ability to complete the study and to comply with study instructions.
Two forms of non hormonal contraception, including intrauterine devices or properly used barrier methods (eg, male or female condoms, diaphragm, or cervical cap). Subjects with surgical sterilization, including tubal ligation or partner's vasectomy, were to have used a form of non-hormonal contraception. A barrier method or sterilization plus spermatocide were acceptable.
Possessed Fitzpatrick skin type I (always burns easily; never tans), II (always burns easily; tans minimally), or III (burns moderately; tans gradually) that would not interfere with the reading of any skin responses. Determination of skin types was based on sunburn and tanning histories, as well as subjects' opinions of their responses to the first 30 to 45 minutes of sun exposure.
...
The ability to complete the study and to comply with study instructions.
Two forms of non hormonal contraception, including intrauterine devices or properly used barrier methods (eg, male or female condoms, diaphragm, or cervical cap). Subjects with surgical sterilization, including tubal ligation or partner's vasectomy, were to have used a form of non-hormonal contraception. A barrier method or sterilization plus spermatocide were acceptable.
Possessed Fitzpatrick skin type I (always burns easily; never tans), II (always burns easily; tans minimally), or III (burns moderately; tans gradually) that would not interfere with the reading of any skin responses. Determination of skin types was based on sunburn and tanning histories, as well as subjects' opinions of their responses to the first 30 to 45 minutes of sun exposure.
Hormonal contraception, including oral, injectable, or implantable methods started at least 2 months prior to screening. If hormonal contraception was started less than 2 months prior to screening, then a form of non-hormonal contraception was to have been added until the third continuous month of hormonal contraception was completed.
The capability of understanding and providing signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed.
Male or female subjects aged from 18 to 65 years, inclusive, at time of consent.

Exclusion Criterias

Participated in a previous study of the same study product.
History of severe reactions from exposure to sunlight, including previous experience with photoallergy, solar urticaria, polymorphous light eruptions, or other photo exacerbated systemic diseases.
Used antihistamines or prescription anti inflammatory drugs within 72 hours of the day 1 visit. Permitted exceptions were acetaminophen at recommended doses and aspirin at doses of ≤81 mg/day.
...
Participated in a previous study of the same study product.
History of severe reactions from exposure to sunlight, including previous experience with photoallergy, solar urticaria, polymorphous light eruptions, or other photo exacerbated systemic diseases.
Used antihistamines or prescription anti inflammatory drugs within 72 hours of the day 1 visit. Permitted exceptions were acetaminophen at recommended doses and aspirin at doses of ≤81 mg/day.
Female subjects who were pregnant, attempting to become pregnant, or breast feeding.
Employees of Hill Top Research or Stiefel Laboratories involved in the study, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee involved in the study.
Investigator inability to evaluate the skin in and around the potential test sites due to sunburns, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin abnormalities.
Current use of any medication which, in the opinion of the investigator, may have affected the evaluation of the study product or placed the subject at undue risk.
Currently receiving allergy injections, or due to receive an injection, within 7 days prior to screening visit 1, or expected to begin injections during study participation.
Current use or expected use of photosensitizing medications (over-the-counter and prescription), herbal supplements, or any use of a known photosensitizing material.
Received any investigational drug within 4 weeks of study day 1 or who were scheduled to receive an investigational drug other than the study product during the study.
Used topical medications (eg, corticosteroids or immunosuppressives) on potential test sites within the last 7 days prior to screening visit 1.
Participated in any patch test study for irritation or sensitization or any test involving ultraviolet exposures within the last 4 weeks.
Clinically relevant history or presence of respiratory (including chronic asthma requiring repetitive drug interventions), gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders.
Clinically significant skin diseases contraindicating participation or interfering with test site evaluations, including psoriasis, eczema, atopic dermatitis, acne, dysplastic nevi, or other skin pathologies.
Currently diagnosed with cancer or had a previous history of cancer, including skin cancer, or severe photodamaged skin. Severe photodamaged skin was characterized by yellow-gray color, wrinkles with no visible normal skin, and prior skin malignancies.
Used contraindicated prescription drugs within 4 weeks or 5 half-lives, whichever was longer, of first dose of study product, unless agreed as not clinically relevant by the principal investigator and the project physician.
Considered immunocompromised or using immunosuppressant drugs.
Considered unable or unlikely to attend the necessary visits.
Suffered from any disease or condition which, in the opinion of the investigator, may have affected the evaluation of the study product or placed the subject at undue risk.
History of known or suspected intolerance to any of the ingredients of the study products (ie, test and comparator products), to the hypoallergenic tape, or to the cotton patches.
Clinically relevant history of or current evidence of abuse of alcohol or other drugs.
Any major illness within 30 days before the screening examination.

Tracking Information

NCT #
NCT01929278
Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline